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

This study has been completed.
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00483262
First received: June 5, 2007
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
Results First Received: June 27, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: CCI-779
Drug: Bortezomib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between June, 2007, and December, 2009, we enrolled patients into our open-label, dose-escalation study at three centres in the USA (Dana-Farber Cancer Institute, Boston, MA; Washington University, St Louis, MO; and the University of Michigan, Ann Arbor, MI).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Applicable

Reporting Groups
  Description
CCI779 and Bortezomib Phase I CCI779 and Bortezomib, Phase I part of this Phase I/II study
CCI779 and Bortezomib Phase II CCI779 and Bortezomib, Phase II part of this Phase I/II study

Participant Flow:   Overall Study
    CCI779 and Bortezomib Phase I     CCI779 and Bortezomib Phase II  
STARTED     20     43  
COMPLETED     20     43  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
CCI779 and Bortezomib Phase I CCI779 and Bortezomib Phase I part of this Phase I/II study.
CCI779 and Bortezomib Phase II CCI779 and Bortezomib Phase II part of this Phase I/II study
Total Total of all reporting groups

Baseline Measures
    CCI779 and Bortezomib Phase I     CCI779 and Bortezomib Phase II     Total  
Number of Participants  
[units: participants]
 		  20     43     63  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     15     23     38  
>=65 years     5     20     25  
Gender  
[units: participants]
 		     
Female     7     24     31  
Male     13     19     32  
Region of Enrollment  
[units: participants]
 		     
United States     20     43     63  



  Outcome Measures
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1.  Primary:   Toxicity. Number of Patients With Specific Toxicities Are Reported.   [ Time Frame: 10 months ]
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2.  Primary:   Best Response to Combination Treatment   [ Time Frame: 10 months ]
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3.  Secondary:   Progression-Free Survival   [ Time Frame: 10 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Irene Ghobrial, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-4198
e-mail: irene_ghobrial@dfci.harvard.edu


Publications of Results:


Responsible Party: Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00483262     History of Changes
Other Study ID Numbers: 06-365
Study First Received: June 5, 2007
Results First Received: June 27, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration