Multiple Myeloma Clinical Trial
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Summary
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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