Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Millennium Pharmaceuticals, Inc.; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bortezomib; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 18 years of age or older

• Must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma

• Monoclonal protein in the serum of greater than or equal to 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma

• ECOG Performance Status 0, 1 or 2

• Laboratory values as outlined in the protocol

Exclusion Criteria:

• Uncontrolled infection

• Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma.

• Pregnant or nursing women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment

• Known to be HIV positive

• Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

• Hypersensitivity to bortezomib, boron or mannitol

• Serious medical or psychiatric illness likely to interfere with participation in this clinical trial

• Patients who may need or are receiving live vaccines for immunization