Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00378209
First received: September 18, 2006
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Lenalidomide
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
65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants screened over a 3 week period.

Reporting Groups
  Description
Lenalidomide, Dexamethasone, Bortezomib Combination

Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.

Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.


Participant Flow:   Overall Study
    Lenalidomide, Dexamethasone, Bortezomib Combination  
STARTED     64 [1]
COMPLETED     42 [2]
NOT COMPLETED     22  
Progressive disease                 11  
Adverse Event                 3  
Initiation of non-protocol therapy                 3  
Physician Decision                 3  
Death                 1  
Treatment delay                 1  
[1] 1 patient who never started treatment was excluded in the analysis.
[2] This included patients who completed at least 8 cycles of combination therapy with all drugs.



  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.
65 patients were enrolled and 64 were treated. One patient who was never treated was excluded from the analysis.

Reporting Groups
  Description
Lenalidomide, Dexamethasone, Bortezomib Combination

Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.

Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.


Baseline Measures
    Lenalidomide, Dexamethasone, Bortezomib Combination  
Number of Participants  
[units: participants]
  64  
Age  
[units: years]
Median ( Full Range )
  65  
  ( 32 to 83 )  
Gender  
[units: participants]
 
Female     22  
Male     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months   [ Time Frame: 6 months after therapy ]

2.  Secondary:   Objective Response Rate   [ Time Frame: Assessed every cycle for up to 8 cycles and best response was reported ]

3.  Secondary:   Duration of Response   [ Time Frame: Assessed at a median follow-up of 44 months ]

4.  Secondary:   Progression Free Survival   [ Time Frame: aassesed at a median follow-up of 44 months ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Paul Richardson
Organization: Dana-Farber Cancer Institute
phone: 617-632-2104
e-mail: Paul_Richardson@dfci.harvard.edu


No publications provided by Dana-Farber Cancer Institute

Publications automatically indexed to this study:

Responsible Party: Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00378209     History of Changes
Other Study ID Numbers: 06-147
Study First Received: September 18, 2006
Results First Received: October 15, 2013
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration