Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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 the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may also stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.

Key facts

Study ID

NCT00398515

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2007-03-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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