Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 2

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

In brief

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 stop cancer cells from dividing so they stop growing or die.

Key facts

Study ID

NCT00079456

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2004-02-01

Last updated by the study team

2013-10-11

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 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

Where it is running

• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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