Status:
COMPLETED
Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus. Secondary * To evaluate the toxicity of everolimus in patients w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00618345
Start Date
March 1 2005
End Date
August 1 2008
Last Update
May 16 2011
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