RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with cyclophosphamide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple myeloma.
OBJECTIVES: * Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma. OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. Patients also receive high-dose cyclophosphamide on days -3 to 0. PROJECTED ACCRUAL: Not specified.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Event-free Survival
Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
Time frame: 1 year
Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
Time frame: 2, 3, 6, 9, and 12 months
Safety and Toxicity
Time frame: 2, 3, 6, 9, and 12 months
Complete Response (CR) Rate and Partial Response (PR) Rate
Time frame: 1 year
Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited
Time frame: 2, 3, 6, 9, and 12 months
Overall Survival
Time frame: 5 years
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