Status:
COMPLETED
Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779. SECONDARY OBJECTIVES: I. Determine the progression-free sur...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of multiple myeloma (MM)
- Salmon-Durie stage IIA or IIIA OR progressive stage IA disease
- Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria
- The following are considered major criteria:
- Plasmacytoma on tissue biopsy
- Bone marrow plasmacytosis with \>= 30% plasma cells
- Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of \>= 1 g/24 hour-urine collection
- The following are considered minor criteria:
- Bone marrow plasmacytosis 10-29%
- Monoclonal globulin spike present, but less than the levels defined for a major criterion
- Lytic bone lesion
- Decrease in normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
- No non-secretory MM (absent serum or urinary M-protein)
- Failed at least 1 prior systemic therapy\* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM
- No solitary plasmacytoma
- Performance status - ECOG 0-2
- More than 6 months
- Absolute neutrophil count \> 1,200/mm\^3
- Platelet count \> 75,000/mm\^3
- AST and ALT =\< 2.5 times upper limit of normal (ULN)
- Bilirubin =\< 1.5 times ULN
- Creatinine =\< 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Fasting cholesterol =\< 350 mg/dL
- Triglycerides =\< 400 mg/dL
- No other concurrent uncontrolled illness
- No active or ongoing infection requiring oral or IV antibiotics
- No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779
- No other prior or concurrent malignancy or myelodysplasia except for the following:
- Basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Localized cancer treated with surgery only with no evidence of disease for \> 5 years
- No psychiatric illness or social situation that would preclude study compliance
- More than 4 weeks since prior thalidomide and recovered
- Prior high-dose chemotherapy and stem cell transplantation allowed
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior high-dose corticosteroids and recovered
- More than 4 weeks since prior bortezomib and recovered
- More than 4 weeks since other prior anti-myeloma systemic therapy and recovered
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00079456
Start Date
February 1 2004
Last Update
October 11 2013
Active Locations (2)
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1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
2
Ohio State University Medical Center
Columbus, Ohio, United States, 43210