Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01054144
Collaborator
Celgene (Industry)
27
Enrollment
1
Location
1
Arm
130.3
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1. Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth). However, if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will be continued until their disease progresses. See the intervention descriptions for further details.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma
Actual Study Start Date :
Jan 14, 2010
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Nov 24, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Response Adapted Therapy

Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.

Drug: Lenalidomide
Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue
Other Names:
  • Revlimid®
  • Drug: Prednisone
    Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue

    Drug: Dexamethasone
    Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Other Names:
  • Decadron
  • Outcome Measures

    Primary Outcome Measures

    1. Combined Therapy - Median Progression Free Survival [up to 36 months]

      Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)

    Secondary Outcome Measures

    1. Response Rate [Every 8 weeks up to 12 months]

      Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).

    2. Number of Participants With Serious Adverse Events [Day 1 through Off Study Date, an average of 48 months]

      Number of participants with serious adverse events

    3. Single Agent - Median Progressive Free Survival (PFS) [First measure at 8 weeks]

      The progression free survival of patients treated with single agent lenalidomide

    4. Number of Participants With 1 Year Overall Survival (OS) [1 Year]

      The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Understand and voluntarily sign an informed consent form

    • Age ≥65 years or not eligible for high dose therapy and autologous stem cell transplant

    • Able to adhere to study visit schedule and other protocol requirements

    • Diagnosed with multiple myeloma and considered to have active disease. Patients must not have received an active chemotherapy regimen or Dexamethasone. Patients may have received palliative radiotherapy at least 2 weeks prior to the study start.

    • Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted in a 24-hour urine collection sample) or by serum free light chains (involved free light chain greater than 100mg/L)

    • Eastern Cooperative Group (ECOG) Performance Status of 0 or 1

    • Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory

    • Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x ULN

    • Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x 10^9/L); Platelets ≥ 100,000 /mm³

    • Hemoglobin > 8 g/dL

    • Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula

    • Low risk myeloma is defined as the absence of the following adverse features[21]: t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy by metaphase analysis; Β2 microglobulin > 5.5.

    • Able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin)

    • Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

    • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per milliliter (mIU/mL) within 10 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.

    Exclusion Criteria:
    • Ongoing severe infection requiring intravenous antibiotic treatment

    • Life expectancy of less than 3 months

    • Performance status of 2, 3 or 4

    • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the patient has been disease-free for at least 2 years

    • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

    • Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.

    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

    • Pregnant or lactating

    • Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

    • Known hypersensitivity to thalidomide

    • Use of any other experimental drug or therapy within 28 days of baseline.

    • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

    • Any prior use of lenalidomide

    • Concurrent use of other anti-cancer agents or treatments

    • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1H. Lee Moffitt Cancer Center and Research InstituteTampaFloridaUnited States33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • Celgene

    Investigators

    • Principal Investigator: Rachid Baz, M.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT01054144
    Other Study ID Numbers:
    • MCC-16018
    • 108562
    • RV-MM-PI-0454
    First Posted:
    Jan 22, 2010
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleResponse Adapted Therapy
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Period Title: Overall Study
    STARTED27
    COMPLETED25
    NOT COMPLETED2

    Baseline Characteristics

    Arm/Group TitleResponse Adapted Therapy
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Overall Participants27
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    0
    0%
    >=65 years
    27
    100%
    Sex: Female, Male (Count of Participants)
    Female
    11
    40.7%
    Male
    16
    59.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    7.4%
    Not Hispanic or Latino
    25
    92.6%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    7.4%
    White
    25
    92.6%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    27
    100%

    Outcome Measures

    1. Primary Outcome
    TitleCombined Therapy - Median Progression Free Survival
    DescriptionProgression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
    Time Frameup to 36 months

    Outcome Measure Data

    Analysis Population Description
    Number of participants who received response adaptive therapy
    Arm/Group TitleResponse Adapted Therapy
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Measure Participants9
    Median (95% Confidence Interval) [months]
    36
    2. Secondary Outcome
    TitleResponse Rate
    DescriptionResponse rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).
    Time FrameEvery 8 weeks up to 12 months

    Outcome Measure Data

    Analysis Population Description
    1 participant could not be evaluated for response.
    Arm/Group TitleResponse Adapted TherapySingle Agent Lenalidomide
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.Participants treated with single agent lenalidomide
    Measure Participants926
    Complete Response & Stringent Complete Response
    1
    3.7%
    4
    NaN
    Very Good Partial Response (VGPR)
    1
    3.7%
    3
    NaN
    Partial Response (PR)
    2
    7.4%
    12
    NaN
    Minimal Response (MR)
    5
    18.5%
    4
    NaN
    Stable Disease
    0
    0%
    3
    NaN
    Overall Response >/= PR
    4
    14.8%
    19
    NaN
    3. Secondary Outcome
    TitleNumber of Participants With Serious Adverse Events
    DescriptionNumber of participants with serious adverse events
    Time FrameDay 1 through Off Study Date, an average of 48 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleResponse Adapted Therapy
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Measure Participants27
    Number [participants]
    20
    74.1%
    4. Secondary Outcome
    TitleSingle Agent - Median Progressive Free Survival (PFS)
    DescriptionThe progression free survival of patients treated with single agent lenalidomide
    Time FrameFirst measure at 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleSingle Agent
    Arm/Group DescriptionParticipants who were treated with single agent lenalidomide only
    Measure Participants18
    Median (95% Confidence Interval) [months]
    29
    5. Secondary Outcome
    TitleNumber of Participants With 1 Year Overall Survival (OS)
    DescriptionThe 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleResponse Adapted Therapy
    Arm/Group DescriptionLenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; Dose level -1: 20 mg daily on days 1 - 4 every 28 days; Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; Dose level -2: 10 mg daily on days 1 - 4 every 28 days; Dose level -3: Discontinue
    Measure Participants27
    Number [participants]
    27
    100%

    Adverse Events

    Time FrameAdverse Events collected from consent through off treatment date, an average of 24 months. Serious Adverse events collected from consent to off-study date, an average of 48 months
    Adverse Event Reporting Description
    Arm/Group TitleAll Participants
    Arm/Group DescriptionAll participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
    All Cause Mortality
    All Participants
    Affected / at Risk (%)# Events
    Total2/27 (7.4%)
    Serious Adverse Events
    All Participants
    Affected / at Risk (%)# Events
    Total20/27 (74.1%)
    Cardiac disorders
    General Cardiac Disorders - Other3/27 (11.1%) 4
    Hypertension1/27 (3.7%) 2
    Hypotension2/27 (7.4%) 2
    Gastrointestinal disorders
    Dehydration1/27 (3.7%) 1
    Diarrhea1/27 (3.7%) 1
    Gastrointestinal disorders, other1/27 (3.7%) 1
    Colon Obstruction1/27 (3.7%) 1
    Hemorrhage, Stomach1/27 (3.7%) 1
    Cholecystitis1/27 (3.7%) 1
    General disorders
    Coagulation1/27 (3.7%) 1
    General disorders - Other1/27 (3.7%) 1
    Fever1/27 (3.7%) 2
    Death1/27 (3.7%) 1
    Chest wall pain1/27 (3.7%) 1
    Limb pain2/27 (7.4%) 2
    Pain -Other1/27 (3.7%) 1
    Infections and infestations
    Colitis, Infectious (e.g. Clostridium difficile)2/27 (7.4%) 2
    Febrile neutropenia3/27 (11.1%) 3
    Infection -Blood2/27 (7.4%) 2
    Infection - Lung3/27 (11.1%) 3
    Infection - Other1/27 (3.7%) 2
    Cellulitis3/27 (11.1%) 3
    Infection - Bladder1/27 (3.7%) 1
    Injury, poisoning and procedural complications
    Fracture1/27 (3.7%) 2
    Investigations
    Hypercalcemia1/27 (3.7%) 1
    Hyperglycemia1/27 (3.7%) 1
    Investigations -Other1/27 (3.7%) 1
    Hypokalemia1/27 (3.7%) 1
    Musculoskeletal and connective tissue disorders
    Muscle weakness1/27 (3.7%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Secondary malignancy1/27 (3.7%) 1
    Nervous system disorders
    Confusion1/27 (3.7%) 1
    Syncope1/27 (3.7%) 1
    Psychiatric disorders
    Mental status1/27 (3.7%) 1
    Renal and urinary disorders
    Renal failure1/27 (3.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea2/27 (7.4%) 2
    Skin and subcutaneous tissue disorders
    Wound complication1/27 (3.7%) 1
    Vascular disorders
    Hemorrhage, CNS1/27 (3.7%) 1
    Cerebrovascular ischemia1/27 (3.7%) 1
    Vascular -Other1/27 (3.7%) 3
    Non-myocardial vascular arterial ischemia1/27 (3.7%) 1
    Other (Not Including Serious) Adverse Events
    All Participants
    Affected / at Risk (%)# Events
    Total27/27 (100%)
    Blood and lymphatic system disorders
    Neutrophils/granulocytes25/27 (92.6%) 265
    Leukopenia22/27 (81.5%) 264
    Low platelet count20/27 (74.1%) 78
    Hemoglobin, low16/27 (59.3%) 75
    Hemolysis1/27 (3.7%) 1
    Ear and labyrinth disorders
    Pain - external ear1/27 (3.7%) 1
    Eye disorders
    Pain - eye1/27 (3.7%) 2
    Gastrointestinal disorders
    Constipation24/27 (88.9%) 46
    Diarrhea23/27 (85.2%) 66
    Nausea17/27 (63%) 37
    Gastrointestinal disorders - Other12/27 (44.4%) 13
    Vomiting11/27 (40.7%) 14
    Dehydration9/27 (33.3%) 12
    Heartburn/dyspepsia7/27 (25.9%) 9
    Distension/bloating, Abdominal5/27 (18.5%) 6
    Dysphagia5/27 (18.5%) 5
    Flatulence2/27 (7.4%) 3
    Dry mouth2/27 (7.4%) 3
    Mucositis/stomatitis - oral cavity2/27 (7.4%) 2
    Dysgeusia2/27 (7.4%) 2
    Enteritis1/27 (3.7%) 1
    Gastritis1/27 (3.7%) 1
    Hemorrhoids1/27 (3.7%) 2
    Obstruction, GI - Colon1/27 (3.7%) 1
    Abdominal Pain NOS12/27 (44.4%) 18
    Gallbladder pain1/27 (3.7%) 1
    General disorders
    Fatigue23/27 (85.2%) 63
    Insomnia13/27 (48.1%) 20
    Fever (in absence of neutropenia)10/27 (37%) 25
    Rigors/chills5/27 (18.5%) 7
    Diaphoresis4/27 (14.8%) 4
    Constitutional symptoms - Other3/27 (11.1%) 3
    Back pain21/27 (77.8%) 45
    Pain - extremity/limb16/27 (59.3%) 29
    Headache16/27 (59.3%) 26
    Joint pain10/27 (37%) 12
    Chest wall pain6/27 (22.2%) 7
    Chest/thorax pain5/27 (18.5%) 7
    Neck pain5/27 (18.5%) 7
    Pain-throat/pharynx/larynx5/27 (18.5%) 6
    Pain - stomach4/27 (14.8%) 4
    Pain - NOS3/27 (11.1%) 3
    Bone pain2/27 (7.4%) 3
    Pain - lymph node2/27 (7.4%) 2
    Pain - oral, gum2/27 (7.4%) 4
    Breast pain1/27 (3.7%) 1
    Buttock pain1/27 (3.7%) 1
    Pain - dental1/27 (3.7%) 1
    Pain - face1/27 (3.7%) 1
    Oral cavity pain1/27 (3.7%) 1
    Pelvic pain1/27 (3.7%) 1
    Sinus pain1/27 (3.7%) 1
    Pain - testicle1/27 (3.7%) 1
    Edema - limb21/27 (77.8%) 52
    Edema -head and neck3/27 (11.1%) 4
    Edema - trunk1/27 (3.7%) 1
    Gait changes5/27 (18.5%) 8
    Gingivitus2/27 (7.4%) 2
    Infections and infestations
    Febrile neutropenia6/27 (22.2%) 7
    Cellulitis9/27 (33.3%) 11
    Infection -Other4/27 (14.8%) 4
    Urinary Tract Infection4/27 (14.8%) 4
    Bronchus infection3/27 (11.1%) 3
    Eye infection2/27 (7.4%) 2
    Pneumonia3/27 (11.1%) 3
    Sinus infection3/27 (11.1%) 3
    Upper airway infection1/27 (3.7%) 1
    Conjunctiva infection2/27 (7.4%) 2
    Peripheral nerve infection1/27 (3.7%) 1
    Nail infection1/27 (3.7%) 1
    wound infection1/27 (3.7%) 1
    Bladder infection1/27 (3.7%) 1
    Colon infection1/27 (3.7%) 1
    Tooth infection1/27 (3.7%) 1
    Mucosal infection1/27 (3.7%) 1
    Investigations
    Hyperglycemia9/27 (33.3%) 13
    Creatinine7/27 (25.9%) 14
    Hyperkalemia7/27 (25.9%) 8
    ALT, SGPT high4/27 (14.8%) 6
    Hyperbilirubinemia4/27 (14.8%) 9
    Hypoalbuminemia3/27 (11.1%) 4
    Alkaline phosphatase3/27 (11.1%) 3
    Hypokalemia3/27 (11.1%) 5
    Investigations - Other11/27 (40.7%) 12
    Hypercalcemia2/27 (7.4%) 3
    Hypocalcemia2/27 (7.4%) 5
    Hypoglycemia2/27 (7.4%) 2
    AST, SGOT1/27 (3.7%) 1
    Hypomagnesemia1/27 (3.7%) 1
    Hypernatremia1/27 (3.7%) 1
    Metabolism and nutrition disorders
    Anorexia12/27 (44.4%) 27
    Weight loss8/27 (29.6%) 11
    Weight gain4/27 (14.8%) 4
    Musculoskeletal and connective tissue disorders
    Pain - muscle3/27 (11.1%) 3
    Musculoskeletal and connective tissue disorders - Other12/27 (44.4%) 19
    Muscle weakess, generalized11/27 (40.7%) 12
    Muscle weakness, extraocular3/27 (11.1%) 3
    Muscle weakness, lower extremities3/27 (11.1%) 3
    Fracture3/27 (11.1%) 3
    Muscle weakness, trunk2/27 (7.4%) 2
    Arthritis2/27 (7.4%) 2
    Myositis1/27 (3.7%) 1
    Nervous system disorders
    Neuropathy, sensory19/27 (70.4%) 38
    Dizziness15/27 (55.6%) 29
    Nervous system disorders -Other9/27 (33.3%) 15
    Tremor8/27 (29.6%) 16
    Neuropathy, motor5/27 (18.5%) 6
    Confusion2/27 (7.4%) 3
    CNS cerebrovascular ischemia1/27 (3.7%) 1
    Memory impairment1/27 (3.7%) 1
    Neuropathy, cranial1/27 (3.7%) 1
    Speech impairment1/27 (3.7%) 1
    Syncope1/27 (3.7%) 1
    Psychiatric disorders
    Depression6/27 (22.2%) 9
    Agitation/Iritability6/27 (22.2%) 8
    Anxiety3/27 (11.1%) 6
    Personality/Behavior changes1/27 (3.7%) 1
    Reproductive system and breast disorders
    Cough16/27 (59.3%) 28
    Respiratory, thoracic and mediastinal disorders
    Dyspnea14/27 (51.9%) 25
    Respirator, thoracic and mediastrinal disorders -Other9/27 (33.3%) 14
    Loss or alteration of voice4/27 (14.8%) 5
    Bronchospasm, wheezing1/27 (3.7%) 1
    Paranasal/sinus reaction1/27 (3.7%) 1
    Obstruction of airway1/27 (3.7%) 1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders -Other14/27 (51.9%) 27
    Rash/desquamation14/27 (51.9%) 15
    Dry skin11/27 (40.7%) 18
    Pruritus/itching10/27 (37%) 18
    Rash, erythema multiforme10/27 (37%) 16
    Brusing9/27 (33.3%) 13
    Hyperpigmentation2/27 (7.4%) 2
    Nail changes2/27 (7.4%) 3
    Rash, acne/acneiform2/27 (7.4%) 2
    Wound complication, non-infectious2/27 (7.4%) 3
    Rash1/27 (3.7%) 1
    Skin breakdown/decubitus ulcer1/27 (3.7%) 1
    Urticaria1/27 (3.7%) 1
    Vascular disorders
    Flushing5/27 (18.5%) 8

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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/TitleRachid Baz, MD
    OrganizationMoffitt Cancer Center
    Phone813-745-3163
    EmailRachid.Baz@moffitt.org
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT01054144
    Other Study ID Numbers:
    • MCC-16018
    • 108562
    • RV-MM-PI-0454
    First Posted:
    Jan 22, 2010
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021