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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 proportion of patients achieving complete response (CR), partial response (PR), or minor response (MR) [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Proportion of patients requiring dose interruption, dose reduction or discontinuance of lenalidomide [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- Proportion 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 ] [ Designated as safety issue: No ]
- TTP [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- OS [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
|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|