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Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT01080391
First received: March 2, 2010
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Relapsed Multiple Myeloma
Interventions: Drug: Dexamethasone
Drug: Lenalidomide
Drug: Carfilzomib

  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 14 July 2010 to 15 Mar 2012. Results are reported as of the data cut-off date of 16 June 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
Lenalidomide and Dexamethasone (Rd) Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.

Participant Flow:   Overall Study
    Lenalidomide and Dexamethasone (Rd)   Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
STARTED   396   396 
Treated   389   392 
COMPLETED   373 [1]   383 [1] 
NOT COMPLETED   23   13 
Lost to Follow-up                4                3 
Withdrawal by Subject                19                10 
[1] Participants are ongoing as of 16 June 2014 or who have died on study.



  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
Lenalidomide and Dexamethasone (Rd) Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
Total Total of all reporting groups

Baseline Measures
   Lenalidomide and Dexamethasone (Rd)   Carfilzomib, Lenalidomide, and Dexamethasone (CRd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 396   396   792 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (9.04)   63.3  (9.21)   63.9  (9.14) 
Gender 
[Units: Participants]
     
Female   164   181   345 
Male   232   215   447 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian/Native Hawaiian or Pacific Islander   3   1   4 
Black or African American   11   12   23 
White   377   377   754 
Other   4   6   10 
Serum β2 Microglobulin 
[Units: Participants]
     
< 2.5 mg/L   77   77   154 
≥ 2.5 mg/L   319   319   638 
Prior Bortezomib Exposure 
[Units: Participants]
     
Yes   261   261   522 
No   135   135   270 
Prior Lenalidomide Exposure 
[Units: Participants]
     
Yes   78   80   158 
No   318   316   634 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. ]

2.  Secondary:   Overall Survival   [ Time Frame: From randomization through the data cutoff date of 16 June 2014. Median follow up time was approximiately 32 months. ]

3.  Secondary:   Overall Response   [ Time Frame: From randomization through the data cutoff date of 16 June 2014.Median follow-up time was approximately 31 months. ]

4.  Secondary:   Disease Control   [ Time Frame: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. ]

5.  Secondary:   Duration of Response   [ Time Frame: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months. ]

6.  Secondary:   Duration of Disease Control   [ Time Frame: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months. ]

7.  Secondary:   QLQ-C30 Global Health Status/Quality of Life Scores   [ Time Frame: Day 1 of Cycles 3, 6, 12, 18 ]


  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: NCT01080391     History of Changes
Other Study ID Numbers: PX-171-009
Study First Received: March 2, 2010
Results First Received: June 8, 2015
Last Updated: November 18, 2015
Health Authority: Austria: Federal Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Agence Française de Sécurité Sanitaire Produits de Santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organisation for Medicines
Hungary: National Institute for Pharmacy
Israel: Ministry of Health
Italy: Agencia Italiana del Farmaco
Netherlands: Medicines Evaluation Board
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Public Health Institue
Serbia: Medicines and Medical Devices Ageny of Serbia
Spain: Spanish Drug Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration