Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Melphalan; Methotrexate; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of active multiple myeloma that requires treatment

• Durie-Salmon stage I, II, and III

• No more than 1 progression after initial therapy

• Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)

• No syngeneic donors

• Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia)

PATIENT CHARACTERISTICS:

Age:

• Under 65

Performance status:

• NCI CTC 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 500/mm^3

• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin less than 2 mg/dL

• AST less than 3 times upper limit of normal (ULN)

• Alkaline phosphatase less than 3 times ULN

Renal:

• Creatinine less than 2 mg/dL

• Creatinine clearance greater than 40 mL/min

Cardiovascular:

• LVEF at least 30% by MUGA scan

Pulmonary:

• DLCO greater than 40% of predicted

• No symptomatic pulmonary disease

Other:

• HIV negative

• No uncontrolled diabetes mellitus

• No active serious infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy

• Prior alkylating-agent therapy allowed if no more than 12 months duration

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• At least 4 weeks since prior surgery

Other:

• All prior therapy no more than 18 months duration