Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate

Criteria

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