Status:
COMPLETED
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 o...
Detailed 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: Pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00258206
Start Date
December 1 2004
End Date
September 7 2007
Last Update
December 6 2017
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410