Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
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.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: rituximab Drug: cyclophosphamide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma|
- Event-free Survival [ Time Frame: 1 year ]Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
- 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 ]
|Study Start Date:||December 2004|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: rituximab + cyclophosphamide
Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
Other Name: RituxanDrug: cyclophosphamide
Other Name: Cytoxan
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258206
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Carol A. Huff, MD||Sidney Kimmel Comprehensive Cancer Center|