Status:
COMPLETED
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Lead Sponsor:
Wen-Kai Weng
Conditions:
Blood Cancer
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism u...
Detailed Description
Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan ...
Eligibility Criteria
Inclusion
- PATIENT INCLUSION CRITERIA
- Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment of Stage I disease
- Patient has HLA-identical sibling donor
- Age ≤ 70 years
- No prior therapy which would preclude the use of low-dose total body irradiation
- Pathology review and diagnosis confirmation by Stanford University Medical Center
- Karnofsky performance status (KPS) \> 70%
- DLCO ≥ 60% predicted
- ALT and AST \< 2 x upper limit of normal (ULN)
- Total bilirubin \< 2 mg/dL
- Serum creatinine \< 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
- HIV-negative
- Signed informed consent document
- PATIENT EXCLUSION CRITERIA
- Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis
- Severe psychological or medical illness
- Prior allogeneic hematopoietic cell transplantation
- Pregnant or lactating
- ALLOGENEIC DONOR INCLUSION CRITERIA
- Age ≥ 17
- HIV-seronegative
- Signed informed consent document
- ALLOGENEIC DONOR EXCLUSION CRITERIA
- Serious medical or psychological illness
- Pregnant or lactating
- Prior malignancies within the last 5 years, except for non-melanoma skin cancers
Exclusion
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00185614
Start Date
August 1 2000
End Date
April 1 2010
Last Update
January 18 2018
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305