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Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00619684
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : April 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Intervention Drug: lenalidomide
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Baseline Participants 18
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  94.4%
>=65 years
1
   5.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
5
  27.8%
Male
13
  72.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
18
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.6%
White
17
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)
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CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF < 0) AND < 5% plasma cells in bone marrow aspirate.

VGPR: More than 90% decrease of MP and urine M protein < 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive.

PR: Over 50% decrease of serum MP AND > 90% reduction in 24h urinary light chain excretion or M proteinuria < 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria>200 mg/d)

Time Frame Up to 9 years
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[Not Specified]
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
5
  27.8%
Very Good Partial Response (VGPR)
2
  11.1%
Partial Response (PR)
3
  16.7%
Minimal Response (MR)
1
   5.6%
2.Secondary Outcome
Title Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hide Description Grade 1-2 adverse events occurring in >10% of participants. Grade 3 or higher adverse events occurring in one or more participants.
Time Frame Up to 30 days after completion of study treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1-2 constipation 28
Grade 1-2 diarrhea 17
Grade 1-2 fatigue 17
Grade 1-2 myalgia 17
Grade 1-2 nausea 11
Grade 1-2 neuropathy 11
Grade 1-2 thrombocytopenia 11
Grade 3 pneumonia 17
Grade 3 H1N1 influenza 11
Grade 3 fever, hypoxia and neuropathy 6
Grade 3 myalgia 6
Grade 3 neuropathy 6
Grade 3 neutropenia 44
3.Secondary Outcome
Title Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide
Time Frame Up to 9 years
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Patients enrolled on the trial who received lenalidomide treatment.
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
13
  72.2%
4.Secondary Outcome
Title Number of Patients Who Experience Improvement in GVHD on Lenalidomide, Defined as the Reduction in Severity of GVHD as Defined by the National Institutes of Health (NIH) Consensus Criteria
Hide Description [Not Specified]
Time Frame Up to 9 years
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Hide Analysis Population Description
Patients who received lenalidomide on study
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title TTP
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Time to Progression (TTP): Time from start of therapy to meeting the definition of Progressive Disease (PD).

PD: 25% increase compared to the lowest value of:

  • Serum MP (absolute increase at least ≥ 0.5 g/dl)
  • Or: Urine MP (absolute increase at least > 200 mg/24h)
  • Or: for patients without measurable MP, Serum Free Light Chain test: the difference between involved and uninvolved FLC levels (absolute increase at least >100 mg/L)
Time Frame Up to 9 years
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Hide Analysis Population Description
Patients who developed Progressive Disease while on lenalidomide treatment
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Months
8.5
(1.2 to 43)
6.Secondary Outcome
Title Overall Survival
Hide Description Kaplan-Meier estimate of survival
Time Frame At 1 and 2 years after starting treatment with lenalidomide
Hide Outcome Measure Data
Hide Analysis Population Description
Patients enrolled on trial who received lenalidomide therapy.
Arm/Group Title Treatment (Lenalidomide)
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Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Percent Overall Survival at 1 year
71
(43 to 87)
Percent Overall Survival at 2 years
58
(31 to 78)
Time Frame Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide)
Hide Arm/Group Description

Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

lenalidomide: Given PO

All-Cause Mortality
Treatment (Lenalidomide)
Affected / at Risk (%)
Total   8/18 (44.44%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide)
Affected / at Risk (%) # Events
Total   7/18 (38.89%)    
General disorders   
Fever, hypoxia, neuralgia *  1/18 (5.56%)  1
Nervous system disorders   
Neuropathy *  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  3/18 (16.67%)  3
Influenza - H1N1 *  2/18 (11.11%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Lenalidomide)
Affected / at Risk (%) # Events
Total   17/18 (94.44%)    
Blood and lymphatic system disorders   
Thrombocytopenia *  2/18 (11.11%)  2
Ear and labyrinth disorders   
Epistaxis *  1/18 (5.56%)  1
Eye disorders   
Dry eyes *  1/18 (5.56%)  1
Gastrointestinal disorders   
Diarrhea *  3/18 (16.67%)  3
Anorexia *  1/18 (5.56%)  1
Nausea *  2/18 (11.11%)  2
Constipation *  5/18 (27.78%)  5
Heartburn *  1/18 (5.56%)  1
General disorders   
Fatigue *  3/18 (16.67%)  3
Fever *  1/18 (5.56%)  1
Infections and infestations   
Yeast infection *  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasm *  1/18 (5.56%)  1
Myalgia *  3/18 (16.67%)  3
Weakness *  1/18 (5.56%)  1
Jaw popping *  1/18 (5.56%)  1
Nervous system disorders   
Peripheral neuropathy *  2/18 (11.11%)  2
Psychiatric disorders   
Depression *  1/18 (5.56%)  1
Insomnia *  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Rash *  2/18 (11.11%)  2
Skin tightness *  1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Dr. William Bensinger
Organization: Fred Hutchinson Cancer Research Ctr
Phone: 2066674730
EMail: wbensing@fredhutch.org
Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00619684     History of Changes
Other Study ID Numbers: 2161.00
NCI-2009-01592 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2161.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: February 20, 2008
First Posted: February 21, 2008
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: May 18, 2017