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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: November 2, 2016
Last verified: November 2016
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Panobinostat
Drug: Bortezomib
Drug: Placebo

  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
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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
Panobinostat + Bortezomib 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 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   Placebo + Bortezomib
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.
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Reporting Groups
  Description
Panobinostat + Bortezomib 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 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   Placebo + Bortezomib   Total 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      185  47.8%      176  46.2%      361  47.0% 
Male      202  52.2%      205  53.8%      407  53.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   249   250   499 
Asian   128   104   232 
Black   5   17   22 
Other   5   10   15 


  Outcome Measures
  Show All Outcome Measures

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 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 ]

4.  Secondary:   Overall 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 ]

5.  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 ]

6.  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 ]

7.  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 ]

8.  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 ]

9.  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 ]

10.  Secondary:   European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group   [ Time Frame: 12, 24 and 48 weeks ]

11.  Secondary:   Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : 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


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

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: November 2, 2016
Health Authority: United States: Food and Drug Administration