Melphalan and Busulfan Followed By Donor Peripheral Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Multiple Myeloma

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

Summary

RATIONALE: Giving chemotherapy, such as melphalan and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving melphalan together with busulfan followed by donor peripheral stem cell transplant, tacrolimus, and methotrexate works in treating patients with multiple myeloma.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Melphalan; Methotrexate; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Stage I disease with disease progression during the second of ≥ 2 lines of prior therapy

• Stage II or III disease, meeting 1 of the following criteria:

• Failed to achieve at least a partial response after ≥ 2 courses of prior therapy

• Progressive disease after ≥ 2 courses of prior therapy

• Presented with high-risk features at diagnosis, including any of the following:

• Cytogenetic abnormality

• Del 13 or 4,14 by fluorescent in situ hybridization (FISH)

• Elevated lactic dehydrogenase

• Beta 2 microglobulin > 5.5

• Circulating peripheral blood plasma cells

• Any stage disease with disease progression > 6 months after prior autologous stem cell transplantation

• Availability of an HLA-matched, related donor between 12 and 75 years of age*

• No bone marrow donors NOTE: *Donors > 75 years of age are eligible at the discretion of the principal investigator

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Creatinine clearance > 60 mL/min

• Bilirubin ≤ 2.5 mg/dL

• ALT/AST < 2 times upper limit of normal

• Cardiac ejection fraction ≥ 49%

• DLCO ≥ 50% corrected

• FEV_1 ≥ 60%

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No cirrhosis

• No chronic inflammatory or fibrotic liver disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 6 months since prior autologous transplantation