Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 12/8/2017 |
| Start Date: | December 2004 |
| End Date: | September 7, 2007 |
Phase II Study of High Dose Cyclophosphamide and Rituximab in 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.
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.
- 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.
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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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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