Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma

• Status: Completed
• Trial end date: 2018-05-07
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving monoclonal antibody therapy together with chemotherapy and autologous peripheral stem cell transplant may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, melphalan, and autologous peripheral stem cell transplant in treating patients with previously treated multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Melphalan; Rituximab; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Previously treated disease

• Candidate for high-dose chemotherapy with melphalan and autologous stem cell transplantation

• No definite evidence of myelodysplasia on pretreatment bone marrow by morphology or by chromosome analysis (e.g., monosomy 7)

• Chromosome abnormalities from the myeloma clone allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 2.0 mg/dL

• Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

• AST ≤ 3 times ULN

• Creatinine ≤ 2 times ULN

• LVEF ≥ 45%

• Corrected pulmonary diffusion capacity ≥ 50%

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other active malignancy (with the exception of nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiation therapy

• No HIV positivity

PRIOR CONCURRENT THERAPY:

• More than 3 weeks since prior myelosuppressive chemotherapy, except cyclophosphamide pulsing for stem cell collection)

• No other concurrent immunotherapy, radiotherapy, chemotherapy or antimyeloma therapy

• Concurrent chronic corticosteroids at doses of prednisone ≤ 20 mg per day (or equivalent) allowed

• Concurrent adjuvant hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate) allowed