Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
NCT00483262
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma | |||
Official Title ICMJE | Phase I/II Trial of Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma | |||
Brief 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. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Multiple Myeloma | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: CCI779 and Bortezomib Phase I/II
In Phase I part, 15 or 25 mg temsirolimus (CCI-779)and 1·3 or 1·6 mg/m² bortezomib was given once a week.In Phase II, patients received intravenous temsirolimus once a week on days 1, 8, 15, 22, and 29 for a cycle of 35 days, and intravenous bortezomib once a week on days 1, 8, 15, and 22 for a cycle of 35 days, the MTD ascertained in the Phase I part. Interventions:
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Publications * | Ghobrial IM, Weller E, Vij R, Munshi NC, Banwait R, Bagshaw M, Schlossman R, Leduc R, Chuma S, Kunsman J, Laubach J, Jakubowiak AJ, Maiso P, Roccaro A, Armand P, Dollard A, Warren D, Harris B, Poon T, Sam A, Rodig S, Anderson KC, Richardson PG. Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study. Lancet Oncol. 2011 Mar;12(3):263-72. doi: 10.1016/S1470-2045(11)70028-6. Epub 2011 Feb 21. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 63 | |||
Original Estimated Enrollment ICMJE | 31 | |||
Actual Study Completion Date ICMJE | February 2012 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00483262 | |||
Other Study ID Numbers ICMJE | 06-365 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Irene Ghobrial, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | October 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |