Status:
COMPLETED
Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune syst...
Detailed Description
OBJECTIVES: Primary * Evaluate transplant-related mortality in patients with multiple myeloma treated with a myeloablative conditioning regimen comprising melphalan and busulfan followed by HLA-matc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Stage I disease with disease progression during the second of ≥ 2 lines of prior therapy
- Stage II or III disease, meeting 1 of the following criteria:
- Failed to achieve at least a partial response after ≥ 2 courses of prior therapy
- Progressive disease after ≥ 2 courses of prior therapy
- Presented with high-risk features at diagnosis, including any of the following:
- Cytogenetic abnormality
- Del 13 or 4,14 by fluorescent in situ hybridization (FISH)
- Elevated lactic dehydrogenase
- Beta 2 microglobulin \> 5.5
- Circulating peripheral blood plasma cells
- Any stage disease with disease progression \> 6 months after prior autologous stem cell transplantation
- Availability of an HLA-matched, related donor between 12 and 75 years of age\*
- No bone marrow donors NOTE: \*Donors \> 75 years of age are eligible at the discretion of the principal investigator
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Creatinine clearance \> 60 mL/min
- Bilirubin ≤ 2.5 mg/dL
- ALT/AST \< 2 times upper limit of normal
- Cardiac ejection fraction ≥ 49%
- DLCO ≥ 50% corrected
- FEV\_1 ≥ 60%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No cirrhosis
- No chronic inflammatory or fibrotic liver disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 months since prior autologous transplantation
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00313625
Start Date
September 1 2005
Last Update
September 21 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024