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A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma (FOCUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT01302392
First received: February 10, 2011
Last updated: October 21, 2015
Last verified: October 2015
Results First Received: July 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Carfilzomib
Drug: Best Supportive Care

  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
Subjects were enrolled from 06 Sep 2010 to 21OCT2012. Results are reported as of the data cut-off date of 10 Jul 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Best Supportive Care

Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).

Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle).

Carfilzomib Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).

Participant Flow:   Overall Study
    Best Supportive Care   Carfilzomib
STARTED   158   157 
Treated   153   157 
COMPLETED   151   156 
NOT COMPLETED   7   1 
Lost to Follow-up                1                0 
Withdrawal by Subject                6                1 



  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.
No text entered.

Reporting Groups
  Description
Best Supportive Care

Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).

Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle).

Carfilzomib Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
Total Total of all reporting groups

Baseline Measures
   Best Supportive Care   Carfilzomib   Total 
Overall Participants Analyzed 
[Units: Participants]
 158   157   315 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.5  (8.02)   63.3  (10.71)   64.4  (9.50) 
Gender 
[Units: Participants]
     
Female   62   75   137 
Male   96   82   178 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   4   1   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   1   2 
White   148   151   299 
Other   5   4   9 
Region 
[Units: Participants]
     
Europe   138   140   278 
Non-Europe   20   17   37 
Number of Prior Regimens to Treat Multiple Myeloma 
[Units: Participants]
     
 19   17   36 
 35   34   69 
≥5   104   106   210 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

3.  Secondary:   Overall Response   [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

4.  Secondary:   Duration of Response   [ Time Frame: From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months. ]

5.  Secondary:   Clinical Benefit Response   [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

6.  Secondary:   Duration of Clinical Benefit   [ Time Frame: From time of achieving clinical benefit through the final analysis data cutoff with longest follow-up time of approximately 30 months. ]

7.  Secondary:   Disease Control   [ Time Frame: From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively. ]

8.  Secondary:   Duration of Disease Control   [ Time Frame: From time of achieving disease control through the final analysis data cutoff with longest follow-up time of approximately 31 months. ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen, Inc.
phone: 866-572-6436


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier: NCT01302392     History of Changes
Other Study ID Numbers: PX-171-011
Study First Received: February 10, 2011
Results First Received: July 6, 2015
Last Updated: October 21, 2015
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