Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

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

• Monoclonal protein in the serum of ≥ 1 g/dL

• Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours

• Measurable light chains by free light chain assay of ≥ 10 mg/dL

• Measurable plasmacytoma

• Must have received prior therapy and have relapsed or refractory disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• ANC ≥ 1,000/mm³

• Platelet count ≥ 75,000/mm³

• Hemoglobin ≥ 8.0 g/dL

• Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)

• AST ≤ 3 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 times ULN

• Calcium < 11 mg/dL

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior cytotoxic chemotherapy

• At least 2 weeks since prior biologic therapy or radiotherapy

• At least 2 weeks since prior corticosteroids

• Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma

• No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational