Overview

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