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PrE1003: Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction

Sponsor
PrECOG, LLC. (Other)
Overall Status
Terminated
CT.gov ID
NCT00790842
Collaborator
Celgene (Industry)
63
Enrollment
16
Locations
3
Arms
109.5
Actual Duration (Months)
3.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.

Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment.

OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]).

Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity.

Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only).

After completion of study treatment, patients are followed every 6 months for up to 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function
Actual Study Start Date :
Jan 21, 2009
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Mar 8, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A - CrCl 30-60 mL/min

Creatinine clearance 30 - 60 mL/min, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

Drug: Lenalidomide
Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity.
Other Names:
  • Revlimid

    • Drug: Dexamethasone
    40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity.
    Other Names:
  • Decadron

    • Drug: Anticoagulants
    Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
    Other Names:
  • Aspirin
  • Heparin
  • Low Molecular Weight Heparin
  • Coumadin

    		•
    Experimental: Group B, CrCl < 30 mL/min

    Creatinine clearance < 30 mL/min, not on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

    Drug: Lenalidomide
    Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity.
    Other Names:
  • Revlimid

    • Drug: Dexamethasone
    40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity.
    Other Names:
  • Decadron

    • Drug: Anticoagulants
    Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
    Other Names:
  • Aspirin
  • Heparin
  • Low Molecular Weight Heparin
  • Coumadin

    		•
    Experimental: Group C, CrCl < 30 mL/min, on dialysis

    Creatinine clearance < 30 mL/min and on dialysis, lenalidomide dose determined in phase I, dexamethasone 40 mg orally days 1, 8, 15 and 22 of a 28 day cycle, and anticoagulants.

    Drug: Lenalidomide
    Given by mouth days 1-21 of a 28-day cycle. There is a 7 day rest (days 22-28). Continue until disease progression or unacceptable toxicity.
    Other Names:
  • Revlimid

    • Drug: Dexamethasone
    40 mg given by mouth days 1, 8, 15 and 22 of a 28-day cycle. Continue until disease progression or unacceptable toxicity.
    Other Names:
  • Decadron

    • Drug: Anticoagulants
    Anticoagulation consisted of aspirin at either 81 mg/day or 325 mg/day at the physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin.
    Other Names:
  • Aspirin
  • Heparin
  • Low Molecular Weight Heparin
  • Coumadin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy [First cycle of therapy (28 days)]

      Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: Grade 3 or higher neutropenia with fever ≥38.5 degrees C Grade 4 neutropenia ≥7 days Grade 4 or higher thrombocytopenia Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause

    2. Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR] [56 months]

      Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components

    Secondary Outcome Measures

    1. Overall Survival Time [56 months]

      Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.

    2. Duration of Response [56 months]

      Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.

    3. Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient [56 months]

      The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.

    4. Renal Function Over Time [56 months]

      To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.

    5. Pharmacokinetics of Lenalidomide in Impaired Renal Function [56 months]

      To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).

    6. Progression-free Survival [56 months]

      Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosed with previously treated multiple myeloma.

    • Measurable disease assessed by one of the following ≤21 days prior to registration:

    • Serum monoclonal protein ≥1 g by protein electrophoresis

    • Urine monoclonal protein >200 mg on 24 hour electrophoresis

    • Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio

    • Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease)

    • If both serum and urine m-components are present, both must be followed in order to evaluate response.

    • All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ≥2 weeks prior to registration.

    • Age ≥18 years.

    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

    • Acceptable organ and marrow function ≤21 days prior to registration:

    • Absolute neutrophil count (ANC) ≥1000/mm³

    • Platelet count ≥75,000/mm³

    • Total bilirubin ≤2 mg/dL

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal

    • Renal impairment at baseline as measured by serum creatinine clearance (CrCl) ≤60 mL/min ≤21 days prior to registration.

    • Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ≥28 days prior to, during, and for ≥28 days after completion of study therapy.

    • Able to take required prophylactic anticoagulation.

    • Able to understand and willingness to sign a written informed consent.

    • Willing to provide blood samples for research purposes (Mayo Clinic sites only).

    • If previously received lenalidomide, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥6 months from start of that therapy.

    Exclusion Criteria:

    • Concurrent use of other anti-cancer agents or treatments. Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.

    • Uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection requiring IV antibiotics

    • Symptomatic congestive heart failure

    • Unstable angina pectoris

    • Uncontrolled cardiac arrhythmia

    • Psychiatric illness/social situation that would limit compliance with study requirements.

    • Any of the following as this regimen may be harmful to a developing fetus or nursing child:

    • Pregnant women

    • Breast-feeding women

    • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.

    • HIV-positive patients on combination antiretroviral therapy.

    • Known hypersensitivity to thalidomide or other immunomodulatory drugs.

    • History of Stevens-Johnson syndrome characterized by a desquamating rash while taking thalidomide or similar drugs.

    • Other active malignancy except for non melanoma skin cancer or in situ cervical or breast cancer.

    • Concurrent radiation therapy, except for palliation of a single painful bone lesion or fracture.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259-5499
    2 Emory University Winship Cancer Atlanta Georgia United States 30322
    3 University of IL at Chicago Chicago Illinois United States 60612
    4 McFarland Clinic Ames Iowa United States 50010
    5 Siouxland Hematology Oncology Associates Sioux City Iowa United States 51101
    6 Michigan Cancer Research Consortium and Oncology Research- St. Joseph Mercy Hospital - Ann Arbor Ann Arbor Michigan United States 48106-0955
    7 Mayo Clinic Rochester Minnesota United States 55905
    8 Metro MN CCOP Saint Louis Park Minnesota United States 55416
    9 Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    10 Kinston Medical Specialists Kinston North Carolina United States 28501
    11 University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
    12 Reading Hospital and Medical Center West Reading Pennsylvania United States 19611
    13 WVU Mary Babb Randolph Cancer Center Morgantown West Virginia United States 26506
    14 Gundersen Lutheran La Crosse Wisconsin United States 54601
    15 Waukesha Memorial Hospital (ProHealth Care) Waukesha Wisconsin United States 53188
    16 Aurora Cancer Center Wauwatosa Wisconsin United States 53226

    Sponsors and Collaborators

    • PrECOG, LLC.
    • Celgene

    Investigators

    • Study Chair: Joseph R. Mikhael, MD, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    PrECOG, LLC.
    ClinicalTrials.gov Identifier:
    NCT00790842
    Other Study ID Numbers:
    • PrE1003
    • RV-MM-PrECOG-0394
    First Posted:
    Nov 14, 2008
    Last Update Posted:
    Oct 24, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PrECOG, LLC.
    Refractory Multiple Myeloma
    Relapsed Multiple Myeloma
    Multiple Myeloma with Renal Dysfunction
    Stage I Multiple Myeloma
    Stage II Multiple Myeloma
    Stage III Multiple Myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Plasmacytoma
    Aspirin
    Dexamethasone
    Lenalidomide
    Heparin
    Calcium heparin
    Heparin, Low-Molecular-Weight
    Tinzaparin
    Dalteparin
    Anticoagulants

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C, Lenalidomide 25 mg/Day
    Arm/Group Description Creatinine clearance (CrCl) of 30 - 60 mL/min. Lenalidomide 10 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 15 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of 30 - 60 mL/min. Treated with lenalidomide 25 mg/day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide 15 mg/every other day on days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of <30 mL/min, not on dialysis. Treated with lenalidomide 25 mg every other day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 15 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance < 30 mL/min, not on dialysis. Treated with lenalidomide at 25 mg/day for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Creatinine clearance of 30 - 60 mL/min and on dialysis. Treated with lenalidomide 15 mg 3 days/week for days 1-21 and dexamethasone 40 mg/day on days 1, 8, 15 and 22 of a 28-day cycle. Anticoagulation consisting of aspirin at 81 or 325 mg/day at physician's discretion. Heparin, low molecular weight heparin, or coumadin could be used if the patient was intolerant to aspirin. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 15 mg 3 times per week, dexamethasone and anticoagulant Creatinine Clearance < 30 mL/min and on dialysis, treated with lenalidomide 10 mg/day, dexamethasone, and anticoagulants Creatinine clearance < 30 mL/min and on dialysis, treated with lenalidomide at 25 mg/day, dexamethasone, and anticoagulants
    Period Title: Dose Level 1
    STARTED 6 0 0 3 0 0 0 3 0 0 0
    Began Treatment 6 0 0 3 0 0 0 3 0 0 0
    COMPLETED 3 0 0 1 0 0 0 1 0 0 0
    NOT COMPLETED 3 0 0 2 0 0 0 2 0 0 0
    Period Title: Dose Level 1
    STARTED 0 3 0 0 3 0 0 0 3 0 0
    Began Treatment 0 3 0 0 3 0 0 0 3 0 0
    COMPLETED 0 0 0 0 2 0 0 0 1 0 0
    NOT COMPLETED 0 3 0 0 1 0 0 0 2 0 0
    Period Title: Dose Level 1
    STARTED 0 0 7 0 0 3 0 0 0 3 0
    Began Treatment 0 0 6 0 0 3 0 0 0 3 0
    COMPLETED 0 0 2 0 0 2 0 0 0 1 0
    NOT COMPLETED 0 0 5 0 0 1 0 0 0 2 0
    Period Title: Dose Level 1
    STARTED 0 0 0 0 0 0 8 0 0 0 5
    Began Treatment 0 0 0 0 0 0 8 0 0 0 5
    COMPLETED 0 0 0 0 0 0 6 0 0 0 3
    NOT COMPLETED 0 0 0 0 0 0 2 0 0 0 2
    Period Title: Dose Level 1
    STARTED 0 0 14 0 0 0 2 0 0 0 0
    Began Treatment 0 0 14 0 0 0 2 0 0 0 0
    COMPLETED 0 0 7 0 0 0 1 0 0 0 0
    NOT COMPLETED 0 0 7 0 0 0 1 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis Total
    Arm/Group Description Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis. Total of all reporting groups
    Overall Participants 29 19 14 62
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    73
    72
    64
    71.5
    Sex: Female, Male (Count of Participants)
    Female
    13
    44.8%
    12
    63.2%
    6
    42.9%
    31
    50%
    Male
    16
    55.2%
    7
    36.8%
    8
    57.1%
    31
    50%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    29
    100%
    18
    94.7%
    14
    100%
    61
    98.4%
    Unknown or Not Reported
    0
    0%
    1
    5.3%
    0
    0%
    1
    1.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    1
    7.1%
    1
    1.6%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    10.3%
    2
    10.5%
    3
    21.4%
    8
    12.9%
    White
    26
    89.7%
    16
    84.2%
    10
    71.4%
    52
    83.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    5.3%
    0
    0%
    1
    1.6%
    Creatinine Clearance (mL/min) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [mL/min]
    42.6
    22.8
    11.5
    27.4

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
    Description Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: Grade 3 or higher neutropenia with fever ≥38.5 degrees C Grade 4 neutropenia ≥7 days Grade 4 or higher thrombocytopenia Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
    Time Frame First cycle of therapy (28 days)

    Outcome Measure Data

    Analysis Population Description
    Patients treated during the dose finding phase of the study
    Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Arm/Group Description CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants. CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants. CrCl < 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    Measure Participants 6 3 6 3 3 3 8 3 3 3 5
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A Lenalidomide 10 mg/Day, Group A Lenalidomide 15 mg/Day, Group A Lenalidomide 25 mg/Day
    Comments Recommended Phase 2 dose for Group A
    Type of Statistical Test Other
    Comments Recommended Phase 2 dose for Group A
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Dose in milligrams per day
    Estimated Value 25
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Group B Lenalidomide 15 mg/2 Days, Group B Lenalidomide 25 mg/2 Days, Group B Lenalidomide 15 mg/Day, Group B Lenalidomide 25 mg/Day
    Comments Recommended phase 2 dose for patients in Group B
    Type of Statistical Test Other
    Comments Recommended phase 2 dose for patients in Group B
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Dose in milligrams/day
    Estimated Value 25
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/minute who are not on dialysis
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Group C Lenalidomide 15 mg 3x/Week, Group C Lenalidomide 10 mg/Day, Group C Lenalidomide 15 mg/Day, Group C Lenalidomide 25 mg/Day
    Comments Recommended phase 2 dose for Group C
    Type of Statistical Test Other
    Comments Recommended phase 2 dose for Group C
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Lenalidomide dose in mg/day
    Estimated Value 25
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/min who are receiving dialysis
    2. Primary Outcome
    Title Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
    Description Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    Patients treated at the recommended phase II dose
    Arm/Group Title Group A CrCl 30-60 mL/Min Group B CrCL<30 mL/Min, Not on Dialysis Group C CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    Measure Participants 20 10 5
    Number (90% Confidence Interval) [percentage of participants]
    60.0
    206.9%
    60.0
    315.8%
    20.0
    142.9%
    3. Secondary Outcome
    Title Overall Survival Time
    Description Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    Eligible, treated patients
    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    Measure Participants 29 19 14
    Median (90% Confidence Interval) [months]
    20.8
    20.0
    NA
    4. Secondary Outcome
    Title Duration of Response
    Description Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression.
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    Patients treated at the recommended phase II dose who experienced a response to treatment
    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Lenalidomide 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    Measure Participants 12 6 1
    Median (Inter-Quartile Range) [Months]
    21.8
    8.4
    25.4
    5. Secondary Outcome
    Title Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient
    Description The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    All patients who started treatment
    Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/Week Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Arm/Group Description CrCl 30-60 mL/min, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl < 30 mL/min, not on dialysis. Lenalidomide days 15 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, not on dialysis. Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, not on dialysis. Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg 3 times a week from days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis, Lenalidomide 10 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis, Lenalidomide 15 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis, Lenalidomide 25 mg/day on days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    Measure Participants 6 3 6 14 3 3 3 8 2 3 3 3 5
    None
    3
    10.3%
    1
    5.3%
    1
    7.1%
    1
    1.6%
    1
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    3
    NaN
    0
    NaN
    0
    NaN
    2
    NaN
    Grade 1
    0
    0%
    0
    0%
    1
    7.1%
    4
    6.5%
    0
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    2
    NaN
    0
    NaN
    Grade 2
    2
    6.9%
    0
    0%
    0
    0%
    3
    4.8%
    0
    NaN
    0
    NaN
    1
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Grade 3
    1
    3.4%
    1
    5.3%
    4
    28.6%
    6
    9.7%
    1
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    Grade 4
    0
    0%
    1
    5.3%
    0
    0%
    0
    0%
    1
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Grade 5
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    6. Secondary Outcome
    Title Renal Function Over Time
    Description To describe renal function over time and to evaluate the safety profile of a onetime increase in lenalidomide dose at least 2 cycles after start of treatment due to improved renal function.
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    This outcome was not analyzed because the dose increase was not implemented.
    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    Measure Participants 0 0 0
    7. Secondary Outcome
    Title Pharmacokinetics of Lenalidomide in Impaired Renal Function
    Description To determine the pharmacokinetics of lenalidomide administration in myeloma patients with impaired renal function (pharmacokinetic analysis will be performed in up to 12 consented Mayo Clinic subjects treated during the Phase II component of the trial (only).
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    As only 1 patient was enrolled from Mayo Clinic during the Phase II component of the study, samples were neither collected nor analyzed for this endpoint.
    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    Measure Participants 0 0 0
    8. Secondary Outcome
    Title Progression-free Survival
    Description Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
    Time Frame 56 months

    Outcome Measure Data

    Analysis Population Description
    Patients treated at the recommended phase II dose
    Arm/Group Title Group A=30-60 CrCl (mL/Min) Group B=CrCL<30 mL/Min Not on Dialysis Group C=CrCL<30 mL/Min and on Dialysis
    Arm/Group Description Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    Measure Participants 20 10 5
    Median (90% Confidence Interval) [Months]
    12.6
    11.4
    NA

    Adverse Events

    Time Frame Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution.
    Adverse Event Reporting Description Serious adverse events include any adverse event occurring at least once at grade 3 or higher. The remaining adverse events occurring in at least 5% of patients (3 or more patients) are reported as other adverse events. Events were captured during each clinic visit while on treatment and for 30 days following the end of treatment.
    Arm/Group Title Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Arm/Group Description CrCl 30-60 mL/min. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl 30-60 mL/min. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl <30 mL/min, not on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Enrolled after determination of recommended phase 2 dose. CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg three times weekly for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. CrCl < 30 mL/min, on dialysis. Lenalidomide 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    All Cause Mortality
    Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 4/14 (28.6%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 0/5 (0%)
    Serious Adverse Events
    Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/6 (83.3%) 2/3 (66.7%) 5/6 (83.3%) 10/14 (71.4%) 3/3 (100%) 3/3 (100%) 1/3 (33.3%) 5/8 (62.5%) 1/2 (50%) 2/3 (66.7%) 3/3 (100%) 3/3 (100%) 4/5 (80%)
    Blood and lymphatic system disorders
    Anemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/5 (20%)
    Other (Eosinophilia) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Pancytopenia) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Thrombocytopenia) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Cardiac disorders
    Atrioventricular Block Complete 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Heart Failure 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Myocardial infarction 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Ear and labyrinth disorders
    Middle ear inflammation 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Eye disorders
    Cataract 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Vitreous hemorrhage 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Gastrointestinal disorders
    Abdominal Distension 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Ascites 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Colitis 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Constipation 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Diarrhea 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Dysphagia 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Gastric hemorrhage 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/5 (0%)
    Intra-abdominal hemorrhage 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Pancreatitis 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/5 (0%)
    Small intestinal obstruction 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Diverticulitis) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    General disorders
    Death 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Multi-organ failure 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/5 (0%)
    Hepatobiliary disorders
    Other (Hepatic cirrhosis) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Hepatobiliary disease) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Infections and infestations
    Abdominal Infection 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Lung infection 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 2/3 (66.7%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 1/3 (33.3%) 0/3 (0%) 1/3 (33.3%) 1/5 (20%)
    Sepsis 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/5 (0%)
    Upper respiratory infection 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Urinary tract infection 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Cellulitis) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Clostridial infection) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Localized infection) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Injury, poisoning and procedural complications
    Fall 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Fracture 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Investigations
    Creatinine Increased 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    INR increased 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Lymphocyte count decreased 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/5 (40%)
    Neutrophil count decreased 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Platelet count decreased 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Weight gain 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    White blood cell count decreased 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Metabolism and nutrition disorders
    Anorexia 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Dehydration 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypercalcemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hyperglycemia 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hyperkalemia 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Hypoalbuminemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Hypocalcemia 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypokalemia 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 2/14 (14.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hyponatremia 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypophosphatemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    Generalized muscle weakness 0/6 (0%) 0/3 (0%) 2/6 (33.3%) 2/14 (14.3%) 1/3 (33.3%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Other (pulmonary mass) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Nervous system disorders
    Memory impairment 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Peripheral motor neuropathy 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Somnolence 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Syncope 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Tremor 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (post-traumatic pain) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Psychiatric disorders
    Agitation 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Delirium 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Depression 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Insomnia 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/6 (0%) 0/3 (0%) 0/6 (0%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/8 (25%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Chronic kidney injury 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Cystitis noninfective 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Uremic encephalopathy) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    Hiccups 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Vascular disorders
    Hypotension 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Peripheral ischemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Thromboembolic Event 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Vasculitis 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Not Including Serious) Adverse Events
    Group A Lenalidomide 10 mg/Day Group A Lenalidomide 15 mg/Day Group A Lenalidomide 25 mg/Day Group A Expansion Cohort Group B Lenalidomide 15 mg/2 Days Group B Lenalidomide 25 mg/2 Days Group B Lenalidomide 15 mg/Day Group B Lenalidomide 25 mg/Day Group B Expansion Cohort Group C Lenalidomide 15 mg 3x/wk Group C Lenalidomide 10 mg/Day Group C Lenalidomide 15 mg/Day Group C Lenalidomide 25 mg/Day
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/6 (83.3%) 2/3 (66.7%) 6/6 (100%) 14/14 (100%) 1/3 (33.3%) 3/3 (100%) 3/3 (100%) 8/8 (100%) 2/2 (100%) 1/3 (33.3%) 2/3 (66.7%) 3/3 (100%) 4/5 (80%)
    Blood and lymphatic system disorders
    Anemia 0/6 (0%) 0/3 (0%) 0/6 (0%) 2/14 (14.3%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Cardiac disorders
    Atrial fibrillation 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/5 (0%)
    Eye disorders
    Blurred vision 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Watering eyes 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Gastrointestinal disorders
    Constipation 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Diarrhea 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Fecal incontinence 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Mucositis oral 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Infections and infestations
    Upper respiratory infection 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Injury, poisoning and procedural complications
    Bruising 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Fall 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Laceration) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Investigations
    Alkaline phosphatase increased 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Lymphocyte count decreased 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/8 (25%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Neutrophil count decreased 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Platelet count decreased 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Weight loss 0/6 (0%) 1/3 (33.3%) 2/6 (33.3%) 2/14 (14.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    White blood cell count decreased 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/14 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Metabolism and nutrition disorders
    Anorexia 0/6 (0%) 1/3 (33.3%) 3/6 (50%) 4/14 (28.6%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Dehydration 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hyperglycemia 0/6 (0%) 1/3 (33.3%) 3/6 (50%) 2/14 (14.3%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypoalbuminemia 0/6 (0%) 1/3 (33.3%) 3/6 (50%) 3/14 (21.4%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypocalcemia 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 6/14 (42.9%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hypokalemia 0/6 (0%) 0/3 (0%) 4/6 (66.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Hyponatremia 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 3/14 (21.4%) 0/3 (0%) 2/3 (66.7%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/6 (0%) 0/3 (0%) 0/6 (0%) 4/14 (28.6%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Back pain 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Chest wall pain 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Generalized muscle weakness 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 5/14 (35.7%) 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Myalgia 0/6 (0%) 0/3 (0%) 2/6 (33.3%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Pain in extremity 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 3/14 (21.4%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Other (Muscle spasms) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/8 (37.5%) 0/2 (0%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/5 (20%)
    Nervous system disorders
    Dizziness 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 3/14 (21.4%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Dysgeusia 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Headache 0/6 (0%) 0/3 (0%) 0/6 (0%) 2/14 (14.3%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/2 (50%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Psychiatric disorders
    Insomnia 1/6 (16.7%) 1/3 (33.3%) 1/6 (16.7%) 2/14 (14.3%) 1/3 (33.3%) 1/3 (33.3%) 2/3 (66.7%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Renal and urinary disorders
    Urinary frequency 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 4/14 (28.6%) 0/3 (0%) 1/3 (33.3%) 1/3 (33.3%) 1/8 (12.5%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/5 (0%)
    Dyspnea 0/6 (0%) 0/3 (0%) 2/6 (33.3%) 5/14 (35.7%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 1/2 (50%) 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/5 (0%)
    Skin and subcutaneous tissue disorders
    Dry skin 0/6 (0%) 0/3 (0%) 2/6 (33.3%) 1/14 (7.1%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Pruritus 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/14 (7.1%) 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/5 (20%)
    Vascular disorders
    Hypotension 0/6 (0%) 0/3 (0%) 0/6 (0%) 2/14 (14.3%) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 0/2 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/5 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title PrECOG Statistician
    Organization PrECOG
    Phone 978-835-3516
    Email jbmanola@gmail.com
    Responsible Party:
    PrECOG, LLC.
    ClinicalTrials.gov Identifier:
    NCT00790842
    Other Study ID Numbers:
    • PrE1003
    • RV-MM-PrECOG-0394
    First Posted:
    Nov 14, 2008
    Last Update Posted:
    Oct 24, 2018
    Last Verified:
    Sep 1, 2018