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Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Onyx Therapeutics, Inc.
Celgene Corporation
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01029054
First received: December 8, 2009
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: November 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Multiple Myeloma
Intervention: Drug: carfilzomib, lenalidomide plus dexamethasone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Carfilzomib, Lenalidomide w/Dexamethasone

Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).

Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.

Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.


Participant Flow:   Overall Study
    Carfilzomib, Lenalidomide w/Dexamethasone  
STARTED     53  
COMPLETED     53  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Carfilzomib, Lenalidomide w/Dexamethasone

Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).

Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.

Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.


Baseline Measures
    Carfilzomib, Lenalidomide w/Dexamethasone  
Number of Participants  
[units: participants]
  53  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 35 to 81 )  
Gender  
[units: participants]
 
Female     14  
Male     39  



  Outcome Measures
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1.  Primary:   The Maximum Tolerated Dose (MTD) of Carfilzomib   [ Time Frame: 6 Months ]

2.  Primary:   The Percentage of Patients That Achieve a Response to Treatment   [ Time Frame: 4 Months After Treatment Start ]

3.  Secondary:   The Percentage of Patients Alive Without Progression   [ Time Frame: 12 Months and 24 Months Post Treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Kaminski, M.D.
Organization: University of Michigan Hospital
phone: 734-936-5310
e-mail: mkaminsk@umich.edu


No publications provided by University of Michigan Cancer Center

Publications automatically indexed to this study:

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01029054     History of Changes
Other Study ID Numbers: UMCC 2009.056, HUM30396
Study First Received: December 8, 2009
Results First Received: November 13, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration