Status:
UNKNOWN
Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
Eligibility Criteria
Inclusion
- Age at diagnosis equal or under 55 year
- Meeting the Durie and Salmon criteria for initial diagnosis of MM
- Stage II or III MM at diagnosis or anytime thereafter
- Symptomatic MM requiring treatment at diagnosis or anytime thereafter
- If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center
- Adequate organ function as measured by:
- Cardiac: Left ventricular ejection fraction at rest greater than 40%
- Hepatic: Bilirubin less than 2 times the upper limit of normal and ALT and AST less than 3 times the upper limit of normal
- Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated)
- Pulmonary: DLCO, FEV1, and FVC greater than 50% of predicted value (corrected for hemoglobin), or O2 saturation greater than 92% of room air
- An adequate autologous graft defined as a cryopreserved PBSC graft containing at least 4.0 x 10\^6 CD34+ cells/kg patient weight; if prior to enrollment it is known that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 x 10\^6 CD34+ cells/kg patient weight; the graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells; the graft can be collected at the transplanting institution or by a referring center; for patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 10\^6 CD34+ cells/kg patient weight
Exclusion
- Never advanced beyond Stage I MM since diagnosis
- Non-secretory MM (absence of a monoclonal protein \[M protein\] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques)
- Plasma cell leukemia
- Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs
- Uncontrolled hypertension
- Uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms)
- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer treated with curative intent more than 5 years previously will be allowed
- Pregnant or breastfeeding
- Seropositive for the human immunodeficiency virus (HIV)
- Unwilling to use contraceptive techniques during and for 12 months following treatment
- Prior allograft or prior autograft
- Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy
- Prior organ transplant requiring immunosuppressive therapy
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2017
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00998270
Start Date
October 1 2009
End Date
October 1 2017
Last Update
June 4 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, Iran