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Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT00511238
First received: August 1, 2007
Last updated: October 11, 2013
Last verified: October 2013
Results First Received: September 27, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: 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
Results of this study are reported in 2 parts, depending on whether a patient was enrolled and treated under the original protocol (referred to as ‘A0’) or under Amendment 1 and subsequent amendments (referred to as ‘A1’).

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 (A0) Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
Carfilzomib (A1) In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

Participant Flow:   Overall Study
    Carfilzomib (A0)   Carfilzomib (A1)
STARTED   46   266 
COMPLETED   4 [1]   40 [1] 
NOT COMPLETED   42   226 
Adverse Event                13                33 
Withdrawal by Subject                2                22 
Progressive Disease                23                157 
various reasons                4                14 
[1] Number of patients who completed 12 cycles of treatment



  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.
Safety population: The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib.

Reporting Groups
  Description
Carfilzomib (A0) Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
Carfilzomib (A1) In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
Total Total of all reporting groups

Baseline Measures
   Carfilzomib (A0)   Carfilzomib (A1)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   266   312 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   26   146   172 
>=65 years   20   120   140 
Gender 
[Units: Participants]
     
Female   21   111   132 
Male   25   155   180 


  Outcome Measures
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1.  Primary:   Best Overall Response Rate (ORR)   [ Time Frame: A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study. ]

2.  Secondary:   Clinical Benefit Response (CBR) (A0 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

3.  Secondary:   Clinical Benefit Response (CBR) (A1 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

4.  Secondary:   Duration of Response (A0 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

5.  Secondary:   Duration of Response (A1 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

6.  Secondary:   Time to Progression (A0 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

7.  Secondary:   Time to Progression (A1 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

8.  Secondary:   Progression-free Survival (A0 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

9.  Secondary:   Progression-free Survival (A1 Only)   [ Time Frame: Response assessments same as described in primary outcome measure ]

10.  Secondary:   Overall Survival (A1 Only)   [ Time Frame: Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years ]


  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: Onyx Medical Information
Organization: Onyx Pharmaceuticals
phone: 1-877-ONYX-121
e-mail: medinfo@onyx.com


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

Responsible Party: Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier: NCT00511238     History of Changes
Other Study ID Numbers: PX-171-003
Study First Received: August 1, 2007
Results First Received: September 27, 2013
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration