Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00966693
Collaborator
National Cancer Institute (NCI) (NIH)
77
1
1
106.8
0.7

Study Details

Study Description

Brief Summary

This phase I/II trial studies the best dose and side effects of lenalidomide and thalidomide, and how well they work with dexamethasone in treating participants with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, thalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the maximum tolerated dose (MTD) of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM). (Phase 1) II. To determine the overall (complete remission [CR)]+ very good partial response [VGPR]+ partial response [PR)] response rate of the combination after 4 cycles of therapy. (Phase 2)
SECONDARY OBJECTIVES:
  1. To determine the overall response rate (ORR). (Phase 1) II. To determine the time to progression (TTP). (Phase 1) III. To determine the progression free survival (PFS). (Phase 1)
  2. To determine the time to best response. (Phase 1) V. To determine the CR, VGPR. (Phase 2)
  3. To determine the time to progression (TTP). (Phase 2) VII. To determine the progression free survival (PFS). (Phase 2) VIII. To determine the time to best response. (Phase 2) IX. To assess the safety of the combination of LTD in patients with RRMM. (Phase 2) X. Time to next therapy. (Phase 2) XI. Symptom measurement - multiple-symptom assessment tool. (Phase 2)

OUTLINE: This is a dose-escalation study of lenalidomide and thalidomide.

Participants receive lenalidomide orally (PO) on days 1-21 and thalidomide PO once daily (QD) on days 1-28. Participants also receive dexamethasone PO QD on days 1-4, 9-12, and 17-20 of courses 1-2, and days 1, 8, 15, and 22 of subsequent courses. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Participants who have stable or responding disease to treatment receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants may receive dexamethasone at the discretion of the investigator.

After completion of study treatment, patients are followed up at 30 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of Lenalidomide (Revlimid), Thalidomide, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date :
Aug 25, 2009
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (lenalidomide, thalidomide, dexamethasone)

Participants receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Participants also receive dexamethasone PO QD on days 1-4, 9-12, and 17-20 of courses 1-2, and days 1, 8, 15, and 22 of subsequent courses. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Participants who have stable or responding disease to treatment receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants may receive dexamethasone at the discretion of the investigator.

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
  • Drug: Lenalidomide
    Given PO
    Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
  • Drug: Thalidomide
    Given PO
    Other Names:
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • Kevadon
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Synovir
  • Talimol
  • Thalomid
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) [After one 28-day cycle]

      To determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM).

    2. Complete Response(CR) and Very Good Partial Response(VGPR) [Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).]

      To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.

    Secondary Outcome Measures

    1. Time to Progression [Up to 9 years]

      Time to Progression was estimated using Kaplan Meier analysis.

    2. Progression Free Survival [Up to 9 years]

      Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

    3. Time to Best Response [Up to 9 years]

      Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

    4. Incidence of Adverse Events [Up to 9 years]

      Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate.

    5. Time to Next Therapy [Up to 4.5 years]

      Estimated using the method of Kaplan and Meier.

    Eligibility Criteria

    Criteria

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

    • Relapsed/refractory multiple myeloma (MM) with measurable levels of myeloma paraprotein in serum (>= 0.5 g/dl), urine (>= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (FLC) ratio

    • Serum creatinine =< 2.5 mg/dl

    • Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide 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 28 days before she starts 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 childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.

    • A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

    • Absolute neutrophil count > 1000 cells/mm^3

    • Platelet count > 50,000 cells/mm3 for patients with < 50% of bone marrow plasma cells and platelet count > 25,000 cells/mm3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells

    • Total bilirubin =< 2.0 mg/dL

    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 x upper limit of normal (ULN)

    • Able to take prophylactic anticoagulation, warfarin or equivalent agent

    • Patient is able to understand and comply with the terms and conditions of the lenalidomide and thalidomide counseling program

    • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist, AND the S.T.E.P.S. program

    Exclusion Criteria:
    • Any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form

    • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)

    • Use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy (radiation therapy allowed within 5 days of completion of radiation therapy).

    • Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Donna Weber, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00966693
    Other Study ID Numbers:
    • 2009-0179
    • NCI-2018-01857
    • 2009-0179
    • P30CA016672
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone 40mg *21 days+ 7 days rest and reevaluation=28 day cycle
    Period Title: Overall Study
    STARTED 3 3 9 49
    Phase 1 Completed 2 3 6 0
    Phase 2 Completed 0 0 0 46
    COMPLETED 2 3 6 26
    NOT COMPLETED 1 0 3 23

    Baseline Characteristics

    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2) Total
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Total of all reporting groups
    Overall Participants 3 3 9 49 64
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    2
    66.7%
    1
    11.1%
    26
    53.1%
    29
    45.3%
    >=65 years
    3
    100%
    1
    33.3%
    8
    88.9%
    23
    46.9%
    35
    54.7%
    Sex: Female, Male (Count of Participants)
    Female
    1
    33.3%
    0
    0%
    3
    33.3%
    19
    38.8%
    23
    35.9%
    Male
    2
    66.7%
    3
    100%
    6
    66.7%
    30
    61.2%
    41
    64.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    3
    6.1%
    3
    4.7%
    Not Hispanic or Latino
    3
    100%
    3
    100%
    9
    100%
    46
    93.9%
    61
    95.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    1
    2%
    1
    1.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    66.7%
    2
    66.7%
    4
    44.4%
    10
    20.4%
    18
    28.1%
    White
    1
    33.3%
    1
    33.3%
    5
    55.6%
    38
    77.6%
    45
    70.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    Relapsed/Refractory Multiple Myeloma (Count of Participants)
    Age >= 18 years old
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    > = 1 line of previous therapy
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    Measurable levels of myeloma >=.5M serum-Protein
    2
    66.7%
    2
    66.7%
    7
    77.8%
    44
    89.8%
    55
    85.9%
    Measurable levels of myeloma >=.2 Urine-Protein
    0
    0%
    1
    33.3%
    7
    77.8%
    42
    85.7%
    50
    78.1%
    Abnormal Free Light Chain Ratio
    2
    66.7%
    3
    100%
    9
    100%
    46
    93.9%
    60
    93.8%
    Creatine < 2.5 mg/dL
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    Platelets > 50,000
    3
    100%
    3
    100%
    9
    100%
    47
    95.9%
    62
    96.9%
    Total Bilirubin < 2.0
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    AST or ALT < 3x Upper Limit
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    Anti-coagulant tolerance (PTT) normal
    2
    66.7%
    3
    100%
    4
    44.4%
    37
    75.5%
    46
    71.9%
    Cognitively Aware & Physically Able
    2
    66.7%
    2
    66.7%
    7
    77.8%
    45
    91.8%
    56
    87.5%
    No Pregnant/Breast Feeding Females
    1
    33.3%
    3
    100%
    9
    100%
    19
    38.8%
    32
    50%
    Females non-procreative sex
    1
    33.3%
    3
    100%
    9
    100%
    19
    38.8%
    32
    50%
    Men non-procreative sex
    2
    66.7%
    3
    100%
    9
    100%
    30
    61.2%
    44
    68.8%
    No Cancer Therapy in 21 days
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    No Desquamating Rash regarding Thalidomide
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%
    Days off prev treatment >= 25
    3
    100%
    3
    100%
    9
    100%
    44
    89.8%
    59
    92.2%
    No Known Study Drug Allergies
    3
    100%
    3
    100%
    9
    100%
    49
    100%
    64
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
    Description To determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM).
    Time Frame After one 28-day cycle

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Count of Participants [Participants]
    1
    33.3%
    0
    0%
    3
    33.3%
    0
    0%
    2. Primary Outcome
    Title Complete Response(CR) and Very Good Partial Response(VGPR)
    Description To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.
    Time Frame Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Partial Remission
    2
    66.7%
    0
    0%
    2
    22.2%
    13
    26.5%
    Progressive Disease
    0
    0%
    2
    66.7%
    2
    22.2%
    6
    12.2%
    Very Good Partial Remission
    0
    0%
    3
    100%
    1
    11.1%
    8
    16.3%
    Minimal Residual Disease
    0
    0%
    0
    0%
    1
    11.1%
    9
    18.4%
    Stringent Complete Remission
    0
    0%
    0
    0%
    0
    0%
    3
    6.1%
    Non Evaluable
    1
    33.3%
    0
    0%
    3
    33.3%
    7
    14.3%
    Stable Disease
    0
    0%
    0
    0%
    0
    0%
    7
    14.3%
    3. Secondary Outcome
    Title Time to Progression
    Description Time to Progression was estimated using Kaplan Meier analysis.
    Time Frame Up to 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Mean (Standard Deviation) [Months]
    32.74
    (27)
    9.04
    (7.49)
    14.61
    (16.41)
    10.02
    (17.61)
    4. Secondary Outcome
    Title Progression Free Survival
    Description Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
    Time Frame Up to 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Mean (Standard Deviation) [Months]
    32.74
    (27)
    9.04
    (7.49)
    14.61
    (16.41)
    10.02
    (17.61)
    5. Secondary Outcome
    Title Time to Best Response
    Description Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
    Time Frame Up to 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Mean (Standard Deviation) [months]
    19
    (1.41)
    5
    (6.08)
    5.16
    (7.03)
    3.3
    (4.2)
    6. Secondary Outcome
    Title Incidence of Adverse Events
    Description Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate.
    Time Frame Up to 9 years

    Outcome Measure Data

    Analysis Population Description
    The Number in each of the arms was insufficient to conduct regression analyses, therefore regression analyses was conducted overall. Participants who were Thalidomide incompatible.
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 2 3 6 49
    Count of Participants [Participants]
    0
    0%
    0
    0%
    2
    22.2%
    10
    20.4%
    7. Secondary Outcome
    Title Time to Next Therapy
    Description Estimated using the method of Kaplan and Meier.
    Time Frame Up to 4.5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    Measure Participants 3 3 9 49
    Median (95% Confidence Interval) [months]
    52.4
    14.3
    10.5
    6.47

    Adverse Events

    Time Frame Baseline to study completion up to 9 years
    Adverse Event Reporting Description
    Arm/Group Title RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Arm/Group Description Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg*21 days+ 7 days rest and reevaluation=28 day cycle Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone *21 days+ 7 days rest and reevaluation=28 day cycle
    All Cause Mortality
    RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Serious Adverse Events
    RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 7/49 (14.3%)
    Gastrointestinal disorders
    Diarrhea 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Abdominal Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Vomiting 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    General disorders
    Fatigue 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Death 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Musculoskeletal and connective tissue disorders
    Muscle Weakness 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Psychiatric disorders
    Altered Mental Status 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Renal and urinary disorders
    Urinary Tract Infection 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 0/3 (0%) 0/3 (0%) 0/9 (0%) 3/49 (6.1%)
    Other (Not Including Serious) Adverse Events
    RTD (Cohort 1, Phase 1) RTD (Cohort 2, Phase 1) RTD (Cohort 3, Phase 1) RTD (Cohort 2, Phase 2)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/3 (100%) 3/3 (100%) 9/9 (100%) 49/49 (100%)
    Blood and lymphatic system disorders
    Lymphatics (Other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 4/49 (8.2%)
    Lymphopenia 0/3 (0%) 1/3 (33.3%) 0/9 (0%) 13/49 (26.5%)
    Cardiac disorders
    Atrial Fibrillation 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 4/49 (8.2%)
    Atrial Injury 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Cardiac General (Other) 0/3 (0%) 1/3 (33.3%) 1/9 (11.1%) 0/49 (0%)
    Diastolic Dysfunction 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 0/49 (0%)
    Hypertension 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 5/49 (10.2%)
    Hypotension 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 8/49 (16.3%)
    Mycardial Ichemia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Pericardial Effusion 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Pulmonary (Other) 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 7/49 (14.3%)
    Sinus Brdaycardia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 1/49 (2%)
    Ear and labyrinth disorders
    Auditory Ear (Other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Hearing Loss 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 1/49 (2%)
    Otitis media 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Tinitus 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Endocrine disorders
    Cushingoid 0/3 (0%) 1/3 (33.3%) 1/9 (11.1%) 0/49 (0%)
    Endocrine (other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Glucose intolerance 0/3 (0%) 1/3 (33.3%) 0/9 (0%) 1/49 (2%)
    Eye disorders
    Cataract 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 0/49 (0%)
    Conjunctival disorder 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Dry Eye Syndrome 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 20/49 (40.8%)
    Eye Muscle Weakness 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Eye Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Flashing Vision 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Ocular/Visual (Other) 2/3 (66.7%) 0/3 (0%) 2/9 (22.2%) 3/49 (6.1%)
    Photosensitivity 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Photophobia 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 0/49 (0%)
    Retinopathy 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 0/49 (0%)
    Vision blurred 2/3 (66.7%) 1/3 (33.3%) 7/9 (77.8%) 29/49 (59.2%)
    Watering Eyes 2/3 (66.7%) 1/3 (33.3%) 1/9 (11.1%) 21/49 (42.9%)
    Gastrointestinal disorders
    Abdominal Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 0/49 (0%)
    Anal Hemmorhage 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Constipation 2/3 (66.7%) 1/3 (33.3%) 6/9 (66.7%) 33/49 (67.3%)
    Diarrhea 1/3 (33.3%) 1/3 (33.3%) 5/9 (55.6%) 32/49 (65.3%)
    Dyspepsia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Esophogeal Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Gastrointestinal General 1/3 (33.3%) 0/3 (0%) 2/9 (22.2%) 7/49 (14.3%)
    Epstaxis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Hemorrhoidal/hemorrhage 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Hiccough 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Jejunal 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Mucositis Oral 1/3 (33.3%) 1/3 (33.3%) 2/9 (22.2%) 24/49 (49%)
    Nausea 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 25/49 (51%)
    Oral Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Pharyngitis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Taste Alteration 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Speech Disorder 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 0/49 (0%)
    Tooth disorder 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Toothache 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Vomiting 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 16/49 (32.7%)
    Voice Alteration 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    General disorders
    Chills 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Constitutional Symptoms 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Dehydration 0/3 (0%) 0/3 (0%) 0/9 (0%) 5/49 (10.2%)
    Edema Limbs 2/3 (66.7%) 3/3 (100%) 8/9 (88.9%) 36/49 (73.5%)
    Fatigue 1/3 (33.3%) 3/3 (100%) 9/9 (100%) 49/49 (100%)
    Fever 2/3 (66.7%) 1/3 (33.3%) 2/9 (22.2%) 17/49 (34.7%)
    Flu-like Symptoms 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 2/49 (4.1%)
    Headache 0/3 (0%) 1/3 (33.3%) 0/9 (0%) 10/49 (20.4%)
    Localized Edema 1/3 (33.3%) 1/3 (33.3%) 1/9 (11.1%) 4/49 (8.2%)
    Hyperhidrosis 0/3 (0%) 0/3 (0%) 0/9 (0%) 3/49 (6.1%)
    Immune system disorders
    Allergy 0/3 (0%) 1/3 (33.3%) 1/9 (11.1%) 1/49 (2%)
    Autoimmune Disorder (Other) 0/3 (0%) 1/3 (33.3%) 0/9 (0%) 0/49 (0%)
    Cytokine release syndrome 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Infections and infestations
    Catheter related infection 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Gastric Infection 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Infection 1/3 (33.3%) 1/3 (33.3%) 2/9 (22.2%) 11/49 (22.4%)
    Mucosal Infection 0/3 (0%) 1/3 (33.3%) 1/9 (11.1%) 1/49 (2%)
    Sepsis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Skin Infection 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 2/49 (4.1%)
    Tooth infection 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Investigations
    Activated PTT 1/3 (33.3%) 3/3 (100%) 7/9 (77.8%) 12/49 (24.5%)
    Acidosis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    ALT Increase 2/3 (66.7%) 1/3 (33.3%) 5/9 (55.6%) 16/49 (32.7%)
    Alkaline Phosphate increase 1/3 (33.3%) 1/3 (33.3%) 4/9 (44.4%) 7/49 (14.3%)
    AST Increase 2/3 (66.7%) 1/3 (33.3%) 4/9 (44.4%) 19/49 (38.8%)
    Hyperbilirubia 1/3 (33.3%) 0/3 (0%) 3/9 (33.3%) 10/49 (20.4%)
    Hypocarpnia 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Hyperglycemia 2/3 (66.7%) 3/3 (100%) 7/9 (77.8%) 45/49 (91.8%)
    Hyperuricemia 1/3 (33.3%) 2/3 (66.7%) 1/9 (11.1%) 18/49 (36.7%)
    Blood Bone Marrow (other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Hypocaligulopathy 1/3 (33.3%) 3/3 (100%) 6/9 (66.7%) 7/49 (14.3%)
    Creatinine increase 1/3 (33.3%) 0/3 (0%) 5/9 (55.6%) 27/49 (55.1%)
    Anemia 3/3 (100%) 1/3 (33.3%) 6/9 (66.7%) 43/49 (87.8%)
    Hypercalcemia 0/3 (0%) 0/3 (0%) 0/9 (0%) 10/49 (20.4%)
    INR Increase 1/3 (33.3%) 1/3 (33.3%) 3/9 (33.3%) 7/49 (14.3%)
    Leukopenia 2/3 (66.7%) 2/3 (66.7%) 6/9 (66.7%) 35/49 (71.4%)
    Metabolic/Laboratory (Other) 2/3 (66.7%) 1/3 (33.3%) 8/9 (88.9%) 29/49 (59.2%)
    ANC Decrease 3/3 (100%) 0/3 (0%) 4/9 (44.4%) 33/49 (67.3%)
    Thromboctopenia 2/3 (66.7%) 1/3 (33.3%) 6/9 (66.7%) 30/49 (61.2%)
    Proteinuria 0/3 (0%) 1/3 (33.3%) 1/9 (11.1%) 3/49 (6.1%)
    Hypoalbumenia 2/3 (66.7%) 2/3 (66.7%) 9/9 (100%) 33/49 (67.3%)
    Hypocalcemia 1/3 (33.3%) 2/3 (66.7%) 8/9 (88.9%) 25/49 (51%)
    Hypomagnesemia 1/3 (33.3%) 1/3 (33.3%) 4/9 (44.4%) 33/49 (67.3%)
    Hypermagnesmia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Hypoglycemia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 4/49 (8.2%)
    Hypophosphatemia 1/3 (33.3%) 1/3 (33.3%) 4/9 (44.4%) 17/49 (34.7%)
    Hyperkalemia 1/3 (33.3%) 0/3 (0%) 1/9 (11.1%) 17/49 (34.7%)
    Hypokalemia 1/3 (33.3%) 0/3 (0%) 3/9 (33.3%) 11/49 (22.4%)
    Hyponatremia 2/3 (66.7%) 1/3 (33.3%) 4/9 (44.4%) 11/49 (22.4%)
    Hypernatremia 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 3/49 (6.1%)
    Hypercholesteremia 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Metabolism and nutrition disorders
    Anorexia 1/3 (33.3%) 0/3 (0%) 2/9 (22.2%) 5/49 (10.2%)
    Tumor Lysis Syndrome 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Weight Gain 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 3/49 (6.1%)
    Musculoskeletal and connective tissue disorders
    Back Pain 0/3 (0%) 0/3 (0%) 4/9 (44.4%) 20/49 (40.8%)
    Bone Development Abnormal 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    BonePain 0/3 (0%) 0/3 (0%) 0/9 (0%) 5/49 (10.2%)
    Joint Disorder 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Joint Pain 0/3 (0%) 1/3 (33.3%) 0/9 (0%) 0/49 (0%)
    Musculoskeletal (Other) 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 12/49 (24.5%)
    Muscle Weakness Lower Limb 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Muscle Weakness 0/3 (0%) 2/3 (66.7%) 2/9 (22.2%) 1/49 (2%)
    Musculoskelatal (Other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 7/49 (14.3%)
    Myositis 0/3 (0%) 0/3 (0%) 0/9 (0%) 3/49 (6.1%)
    Neck Pain 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Osteoporsis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Nervous system disorders
    Dizziness 2/3 (66.7%) 2/3 (66.7%) 6/9 (66.7%) 31/49 (63.3%)
    Gait Abnormal 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Memory Impairement 2/3 (66.7%) 1/3 (33.3%) 5/9 (55.6%) 30/49 (61.2%)
    Myalgia 2/3 (66.7%) 2/3 (66.7%) 2/9 (22.2%) 19/49 (38.8%)
    Neurology (Other) 2/3 (66.7%) 0/3 (0%) 6/9 (66.7%) 10/49 (20.4%)
    Pain 0/3 (0%) 0/3 (0%) 3/9 (33.3%) 30/49 (61.2%)
    Pain (Other) 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 4/49 (8.2%)
    Pain in extremity 1/3 (33.3%) 1/3 (33.3%) 2/9 (22.2%) 6/49 (12.2%)
    Peripheral sensory neuropathy 2/3 (66.7%) 2/3 (66.7%) 7/9 (77.8%) 41/49 (83.7%)
    Peripheral motor neuropathy 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Seizure 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Tremor 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 8/49 (16.3%)
    Psychiatric disorders
    Agitation 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Anxiety 1/3 (33.3%) 0/3 (0%) 3/9 (33.3%) 8/49 (16.3%)
    Confusion 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 3/49 (6.1%)
    Depressed Conciousness Level 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Depression 0/3 (0%) 0/3 (0%) 0/9 (0%) 3/49 (6.1%)
    Insomnia 0/3 (0%) 0/3 (0%) 4/9 (44.4%) 8/49 (16.3%)
    Irratibility 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 1/49 (2%)
    Renal and urinary disorders
    Hemorrhage Urinary 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Renal/Genitourinary (Other) 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 3/49 (6.1%)
    Urinary Urgency 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Urinary Retention 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Urinary Tract Infection 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 9/49 (18.4%)
    Reproductive system and breast disorders
    Vaginal hemmorrhage 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Respiratory, thoracic and mediastinal disorders
    Adult Respiratory Distress 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Apnea 0/3 (0%) 0/3 (0%) 1/9 (11.1%) 0/49 (0%)
    Bronchial Hemmorhage 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Bronchospasm 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Chest pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Cough 2/3 (66.7%) 0/3 (0%) 4/9 (44.4%) 17/49 (34.7%)
    Dyspnea 2/3 (66.7%) 2/3 (66.7%) 7/9 (77.8%) 38/49 (77.6%)
    Pneumonia 1/3 (33.3%) 1/3 (33.3%) 1/9 (11.1%) 13/49 (26.5%)
    Rhinitis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Sinus Pain 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Sinusitis 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 4/49 (8.2%)
    Upper Respiratory Infection 1/3 (33.3%) 1/3 (33.3%) 2/9 (22.2%) 18/49 (36.7%)
    Skin and subcutaneous tissue disorders
    Brusing 0/3 (0%) 0/3 (0%) 0/9 (0%) 4/49 (8.2%)
    Dermatological/Skin (other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Dry Skin 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)
    Rash acneform 0/3 (0%) 0/3 (0%) 0/9 (0%) 4/49 (8.2%)
    Rash desquamating 1/3 (33.3%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Surgical and medical procedures
    Treatment related to Secondary Malignancy 0/3 (0%) 0/3 (0%) 0/9 (0%) 4/49 (8.2%)
    Urostomy stenosis 0/3 (0%) 0/3 (0%) 0/9 (0%) 1/49 (2%)
    Vascular disorders
    Hematoma 0/3 (0%) 0/3 (0%) 2/9 (22.2%) 2/49 (4.1%)
    Vascular (other) 0/3 (0%) 0/3 (0%) 0/9 (0%) 2/49 (4.1%)

    Limitations/Caveats

    No pharmaco-dynamic marker to support an effect of signaling downregulation in lenalidomide-refractory patients to corroborate low dose thalidomide (50-100 mg) with or without dexamethasone has a therapeutic benefit with lenalidomide.

    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/Title Weber,Donna M.,M.D. / Lymphoma/Myeloma
    Organization UT MD Anderson Cancer Center
    Phone 713-792-2860
    Email dmweber@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00966693
    Other Study ID Numbers:
    • 2009-0179
    • NCI-2018-01857
    • 2009-0179
    • P30CA016672
    First Posted:
    Aug 27, 2009
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Oct 1, 2020