Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2011-05-27
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Melphalan; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma meeting 1 of the following criteria:

• Bone marrow plasmacytosis with at least 10% plasma cells

• Sheets of plasma cells

• Biopsy-proven plasmacytoma

• Meets at least 1 of the following criteria:

• Presence of myeloma (M)-protein in the serum

• Presence of M-protein in the urine

• Radiographic evidence of osteolytic lesions

• Generalized osteoporosis allowed if at least 20% plasma cells in bone marrow

• No non-secretory myeloma

• Prior M-protein in serum or urine allowed provided patient is now in complete remission

• Must be receiving conventional-dose chemotherapy as initial therapy or as salvage therapy

• Must have HLA-A, -B, and -DR genotypically identical sibling donor

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• AST no greater than 3 times upper limit of normal

• Bilirubin less than 2.0 mg/dL

Renal:

• Not specified

Cardiovascular:

• LVEF greater than 40% at rest if symptomatic cardiac disease is present

Pulmonary:

• DLCO greater than 50% of predicted (corrected for hemoglobin) if symptomatic pulmonary disease is present

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior autologous or allogeneic peripheral blood stem cell or bone marrow transplantation

Chemotherapy:

• See Disease Characteristics

• More than 28 days since prior chemotherapy (including primary chemotherapy for hematopoietic stem cell collection)

• No other concurrent cytotoxic chemotherapy between autologous and allogeneic transplantation

Endocrine therapy:

• Prior dexamethasone or other corticosteroids allowed

• Concurrent corticosteroids between autologous and allogeneic transplantation allowed

Radiotherapy:

• Concurrent radiotherapy between autologous and allogeneic transplantation allowed

Surgery:

• Not specified