Status:
COMPLETED
Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage II Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of temsirolimus when given together with lenalidomide in treating patients with previously treated multiple myeloma. Lenalidomide may stop...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of CCI-779 (temsirolimus) when given together with lenalidomide in patients with previously treated multiple myeloma. SECONDARY OBJECTIVES...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of multiple myeloma (MM)
- Salmon-Durie stage IIA or IIIA
- No stage B disease
- Meets ≥ 1 major AND 1 minor criterion OR ≥ 3 minor criteria
- The following are considered major criteria:
- Plasmacytoma on tissue biopsy
- Bone marrow plasmacytosis with ≥ 30% plasma cells
- Monoclonal paraprotein ≥ 3,500 mg/dL (IgG) or ≥ 2,000 mg/dL (IgA) OR monoclonal protein (Bence-Jones protein) ≥ 1,000 mg by 24-hour urine collection
- The following are considered minor criteria:
- Bone marrow plasmacytosis 10-29% of marrow cellularity
- Monoclonal globulin spike \< 3,500 mg/dL (IgG) or \< 2,000 mg/dL (IgA)
- Lytic bone lesions
- Decrease in normal IgM (\< 50 mg/dL), IgA (\< 100 mg/dL), or IgG (\< 600 mg/dL)
- Disease progression after ≥ 1 prior systemic treatment regimen\* for MM (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib), defined as \> 25% increase in serum or urine M-protein
- No solitary plasmacytoma
- No non-secretory MM (absent serum or urinary M-protein)
- ECOG performance status 0-2
- Life expectancy \> 6 months
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Creatinine ≤ 2.0 mg/dL
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Fasting cholesterol ≤ 350 mg/dL
- Fasting triglycerides ≤ 400 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception
- Must agree not to donate blood, sperm, or ova during and for 4 weeks after completion of study treatment
- 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 history of recurrent deep vein thrombosis (DVT)/pulmonary embolism (PE) or DVT/PE occurring while on therapeutic levels of anticoagulation
- Patients with DVT/PE within the past 6 months are eligible provided they receive full anticoagulation during study treatment
- No active infection requiring oral or intravenous antibiotics
- No uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study compliance
- No known hepatitis B or C
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or CCI-779
- See Disease Characteristics
- Prior lenalidomide allowed
- Prior high-dose chemotherapy with stem cell transplantation allowed
- More than 4 weeks since prior chemotherapy or other antimyeloma systemic therapy (e.g., thalidomide, bortezomib, or high-dose corticosteroids) and recovered
- No prior exposure to both lenalidomide and mTOR inhibitors (given together)
- Treatment with single-agent lenalidomide or single-agent mTOR inhibitor allowed
- No other concurrent investigational agents
- No concurrent corticosteroids unless for physiologic maintenance
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent myeloid growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
- No concurrent grapefruit or grapefruit juice
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00398515
Start Date
March 1 2007
Last Update
September 30 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210