Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma

Tehran University of Medical Sciences

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Multiple Myeloma

Treatments

Procedure: Autologous bone marrow transplantation

Procedure: Allogeneic bone marrow transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00998270

HORCSCT-0901

Details and patient eligibility

About

A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.

Enrollment

185 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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