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Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00111813
First received: May 25, 2005
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
Results First Received: March 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: vorinostat
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
No text entered.

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
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2

Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2

Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2

Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

Participant Flow:   Overall Study
    Vorinostat 200 mg + Bortezomib 0.7 mg/m^2     Vorinostat 200 mg + Bortezomib 0.9 mg/m^2     Vorinostat 300 mg + Bortezomib 1.3 mg/m^2     Vorinostat 400 mg + Bortezomib 0.9 mg/m^2     Vorinostat 400 mg + Bortezomib 1.1 mg/m^2     Vorinostat 400 mg + Bortezomib 1.3 mg/m^2  
STARTED     3     3     10     6     6     6  
COMPLETED     0     0     0     1     0     0  
NOT COMPLETED     3     3     10     5     6     6  
Adverse Event                 1                 2                 4                 2                 2                 2  
Progressive disease                 2                 1                 5                 3                 4                 3  
Lack of Efficacy                 0                 0                 0                 0                 0                 1  
Not specified                 0                 0                 1                 0                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants

Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).

Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  34  
Age  
[units: years]
Mean ± Standard Deviation 		  60.6  ± 8.1  
Gender  
[units: participants]
 		 
Female     13  
Male     21  



  Outcome Measures
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1.  Primary:   Mean Duration of Treatment With Vorinostat   [ Time Frame: Day 1 to an event causing discontinuation from the study, assessed up to 29 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug   [ Time Frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months ]
  Show Outcome Measure 2

3.  Secondary:   Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib   [ Time Frame: Day 1 to disease progression, toxicity, or death, assessed up to 29 months ]
  Show Outcome Measure 3

4.  Secondary:   Clinical AE Summary   [ Time Frame: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months) ]
  Show Outcome Measure 4

5.  Secondary:   Laboratory AE Summary   [ Time Frame: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Vice President , Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00111813     History of Changes
Other Study ID Numbers: MK-0683-015, 2005_018
Study First Received: May 25, 2005
Results First Received: March 10, 2011
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration