This trial is active, not recruiting.

Condition multiple myeloma and plasma cell neoplasm
Treatments rituximab, cyclophosphamide
Phase phase 2
Target CD20
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date December 2004
End date November 2015
Trial size 29 participants
Trial identifier NCT00258206, J0478 CDR0000441169, JHOC-J04101102, JHOC-J0478, P30CA006973


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Event-free survival at 1 year
time frame:
Safety of maintenance rituximab following high dose cyclophosphamide at 2, 3, 6, 9, and 12 months
time frame:

Secondary Outcomes

Safety and toxicity at 2, 3, 6, 9, and 12 months
time frame:
Complete response (CR) rate and partial response (PR) rate at 1 year
time frame:
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
time frame:
Overall survival at 5 years
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma, meeting 1 of the following criteria: - High-risk disease in first remission, as defined by the following: - Beta-2 microglobulin > 5.0 mg/dL - Chromosome 13 deletion - Primary refractory disease - Relapsed disease after achieving a response to prior chemotherapy - The following diagnoses are not allowed: - POEMS syndrome - Plasma cell leukemia - Amyloidosis - Nonsecretory myeloma - No evidence of spinal cord compression PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - Has good organ function - Is in good physical condition - No active infection requiring antibiotics - No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No persistently detectable donor cells after prior allogeneic stem cell transplantation - No prior rituximab Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 28 days since prior therapy

Additional Information

Official title Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.