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
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma|
- Event-free survival at 1 year [ Designated as safety issue: No ]
- Safety of maintenance rituximab following high dose cyclophosphamide at 2, 3, 6, 9, and 12 months [ Designated as safety issue: Yes ]
- Safety and toxicity at 2, 3, 6, 9, and 12 months [ Designated as safety issue: Yes ]
- Complete response (CR) rate and partial response (PR) rate at 1 year [ Designated as safety issue: No ]
- Effect of rituximab by clonogenic growth of multiple myeloma (MM) progenitors and the mechanisms by which MM stem cells are inhibited at 2, 3, 6, 9, and 12 months [ Designated as safety issue: No ]
- Overall survival at 5 years [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Experimental: rituximab + cyclophosphamide||Biological: rituximab Drug: cyclophosphamide|
- 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|