Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01023308
First received: November 30, 2009
Last updated: September 21, 2015
Last verified: September 2015
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Panobinostat
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
Participant flow is based on the Full analysis set consists of all randomized patients.

Reporting Groups
  Description
Panobinostat + Bortezomib + Dexamethasone Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
Placebo + Bortezomib + Dexamethasone Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

Participant Flow:   Overall Study
    Panobinostat + Bortezomib + Dexamethasone     Placebo + Bortezomib + Dexamethasone  
STARTED     387     381  
COMPLETED     102 [1]   102 [1]
NOT COMPLETED     285     279  
Abnormal test proceedure results                 3                 8  
Administrative problems                 2                 1  
Adverse Event                 130                 66  
Death                 21                 17  
Disease progression                 82                 153  
New Cancer therapy                 4                 7  
Protocol Violation                 3                 4  
Untreated                 5                 5  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 34                 18  
[1] completed all planned cycles of study treatment as per protocol



  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
Panobinostat + Bortezomib + Dexamethasone Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
Placebo + Bortezomib + Dexamethasone Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
Total Total of all reporting groups

Baseline Measures
    Panobinostat + Bortezomib + Dexamethasone     Placebo + Bortezomib + Dexamethasone     Total  
Number of Participants  
[units: participants]
  387     381     768  
Age  
[units: years]
Mean (Standard Deviation)
  62.4  (9.34)     61.8  (9.43)     62.1  (9.38)  
Gender  
[units: participants]
     
Female     185     176     361  
Male     202     205     407  
Race/Ethnicity, Customized  
[units: Participants]
     
Caucasian     249     250     499  
Asian     128     104     232  
Black     5     17     22  
Other     5     10     15  



  Outcome Measures
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1.  Primary:   Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

2.  Primary:   Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

3.  Secondary:   Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

4.  Secondary:   Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

5.  Secondary:   Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

6.  Secondary:   Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.   [ Time Frame: 45 months ]

7.  Secondary:   European Organization for Research and Treatment of Cancer Multiple Myeloma Module( EORTC QLQ-MY20) -Change From Baseline by Treatment Group   [ Time Frame: 12, 24 and 48 weeks ]

8.  Secondary:   European Organization for Research and Treatment of Cancer Quality of Life Questionaire : EORTC QLQ-C30 - Summary Statistics by Treatment Group   [ Time Frame: 12, 24 and 48 weeks ]

9.  Secondary:   FACT/GOG-NTX-Change From Baseline by Treatment Group   [ Time Frame: 12, 24 and 48 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


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01023308     History of Changes
Other Study ID Numbers: CLBH589D2308
2009-015507-52 ( EudraCT Number )
Study First Received: November 30, 2009
Results First Received: March 23, 2015
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration