Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT00619684|
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : April 18, 2017
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: lenalidomide||Phase 2|
I. To evaluate response of relapsed or progressive multiple myeloma to lenalidomide after allogeneic stem cell transplant.
II. Proportion of patients achieving a complete, partial or minor response.
I. Evaluate toxicity and tolerability of lenalidomide in this setting.
II. For patients with chronic graft-versus-host disease (GVHD), evaluate the response to lenalidomide.
III. Evaluate time to progression (TTP).
IV. Evaluate overall survival (OS).
Patients receive lenalidomide orally (PO) on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression|
|Study Start Date :||February 2008|
|Primary Completion Date :||August 2015|
|Study Completion Date :||September 2015|
Experimental: Treatment (lenalidomide)
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.
- Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) [ Time Frame: Up to 9 years ]
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)
- Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Up to 30 days after completion of study treatment ]Grade 1-2 adverse events occurring in >10% of participants. Grade 3 or higher adverse events occurring in one or more participants.
- Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide [ Time Frame: Up to 9 years ]Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression
- 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 [ Time Frame: Up to 9 years ]
- TTP [ Time Frame: Up to 9 years ]
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)
- Overall Survival [ Time Frame: At 1 and 2 years after starting treatment with lenalidomide ]Kaplan-Meier estimate of survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619684
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||William Bensinger||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|