Status:
COMPLETED
Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. ...
Detailed Description
OBJECTIVES: Primary * To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma, meeting 1 of the following criteria:
- Stage I disease with a bone lesion
- Stage II or III disease meeting any of the following criteria:
- Elevated beta-2 microglobulin
- Deletion of chromosome 13
- Refractory or relapsed disease
- Presence of an evaluable monoclonal component
- Must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
- HLA identical family donor available
- Bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
- PATIENT CHARACTERISTICS:
- Karnofsky 70-100%
- No contraindications to allogeneic transplantation
- No contraindications to drugs used in conditioning regimen
- No psychiatric illness
- No other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
- No serious and uncontrolled infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 1 month since participation in another prior clinical trial
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00802568
Start Date
April 1 2007
Last Update
May 16 2011
Active Locations (1)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273