Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: lenalidomide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression|
- 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
|Study Start Date:||February 2008|
|Study Completion Date:||September 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|