Phase II Study of High Dose Cyclophosphamide and Rituximab in Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Phase II Study of High Dose Cyclophosphamide and Rituximab in 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival at 1 year
Safety Issue:
No
Principal Investigator
Carol A. Huff, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
J0478 CDR0000441169
NCT ID:
NCT00258206
Start Date:
December 2004
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
