Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma (MACS1271)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01083602
First received: March 8, 2010
Last updated: April 8, 2015
Last verified: February 2015
Results First Received: February 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Relapsed and Bortezomib Refractory Multiple Myeloma
Refractory Multiple Myeloma
Multiple Myeloma in Relapse
Interventions: Drug: panobinostat
Drug: bortezomib
Drug: 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
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
Panobinostat + Bortezomib & Dexamethasone panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma

Participant Flow:   Overall Study
    Panobinostat + Bortezomib & Dexamethasone  
STARTED     55  
COMPLETED     0  
NOT COMPLETED     55  
Adverse Event                 11  
New Cancer Therapy                 2  
Death                 1  
Withdrawal by Subject                 5  
Lack of Efficacy                 36  



  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.
The study population consisted of adult patients with relapsed and bortezomib-refractory MM who had received at least 2 prior lines of therapy and had been exposed to an IMiD (thalidomide or lenalidomide). Bortezomib-refractory was defined as demonstrated disease progression on or within 60 days of the last bortezomib -containing line of therapy.

Reporting Groups
  Description
Panobinostat + Bortezomib & Dexamethasone panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma

Baseline Measures
    Panobinostat + Bortezomib & Dexamethasone  
Number of Participants  
[units: participants]
  55  
Age  
[units: years]
Mean (Standard Deviation)
  61.9  (10.54)  
Gender  
[units: participants]
 
Female     26  
Male     29  



  Outcome Measures
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1.  Primary:   Overall Response Rate (PR+nCR+CR)   [ Time Frame: after eight cycyles of treatment (24 weeks) ]

2.  Secondary:   Responders to Treatment   [ Time Frame: after eight cycyles of treatment (24 weeks) ]

3.  Secondary:   Time to Response (Greater Than or Equal to PR) Based on Investigator Assessment   [ Time Frame: after eight cycyles of treatment (24 weeks) ]

4.  Secondary:   Progression-free Survival   [ Time Frame: 24 weeks ]

5.  Secondary:   Time to Progression   [ Time Frame: 24 weeks ]

6.  Secondary:   Over All Survival   [ Time Frame: 24 weeks ]


  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: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01083602     History of Changes
Other Study ID Numbers: CLBH589DUS71
Study First Received: March 8, 2010
Results First Received: February 23, 2015
Last Updated: April 8, 2015
Health Authority: United States: Food and Drug Administration