Phase II Study of Lenalidomide and Rituximab for Patients With Relapsed and/or Refractory CD20+ Multiple Myeloma
- To determine the safety and efficacy, as determined by response rate (complete response
[CR] + near CR + partial response), of lenalidomide administered with rituximab in
patients with relapsed and/or refractory CD20+ multiple myeloma.
- To assess the effects of this regimen on patient lymphocyte subsets (T, B, and NK
cells) in peripheral blood and bone marrow samples from these patients.
- To perform detailed phenotypic analyses of NK cells in patient blood and bone marrow
samples at baseline and post-treatment.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment with
lenalidomide repeats every 28 days for at least 4 courses. Patients also receive rituximab
IV once weekly in weeks 2-5 and in week 13. Patients with stable disease then receive
rituximab once every 8 weeks. Treatment continues in the absence of disease progression or
Peripheral blood samples are collected at baseline, and after courses 2 and 4. Samples are
examined by flow cytometry for lymphocyte subset analysis (T-, B-, and NK-cell percentages
and absolute numbers) and NK-cell phenotyping (CD16, CD56, NKG2D expression). Samples are
also examined by immunologic assays of isolated peripheral blood mononuclear cells. Bone
marrow aspirate samples are also collected at baseline and after course 2. Bone marrow
mononuclear cells are isolated and evaluated by CD138+ plasma cell selection, ex vivo
antibody-dependent cellular cytotoxicity assays, and bone marrow lymphocyte subset analysis.
After completion of study therapy, patients are followed at 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Final response rate after 4 courses of treatment
Hani Hassoun, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|