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A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT00833560
First received: January 23, 2009
Last updated: November 11, 2014
Last verified: November 2014
Results First Received: October 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Cyclophosphamide
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
401 participants were enrolled at 41 study sites in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m^2 per cycle in Part 1 were excluded.

Reporting Groups
  Description
Cyclophosphamide + Bortezomib + Dexamethasone Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles

Participant Flow:   Overall Study
    Cyclophosphamide + Bortezomib + Dexamethasone  
STARTED     395  
COMPLETED     353  
NOT COMPLETED     42  
Toxicity                 13  
Adverse Event                 11  
Protocol Violation                 6  
Lack of Efficacy                 4  
Death                 2  
Pregression of other disease                 1  
Not specified                 5  



  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
Cyclophosphamide + Bortezomib + Dexamethasone Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles

Baseline Measures
    Cyclophosphamide + Bortezomib + Dexamethasone  
Number of Participants  
[units: participants]
  395  
Age  
[units: Years]
Mean ± Standard Deviation
  52.4  ± 6.5  
Age, Customized  
[units: Participants]
 
Between 20 and 39 years     17  
Between 40 and 49 years     109  
Between 50 and 60 years     253  
>65 years     16  
Gender  
[units: Participants]
 
Female     166  
Male     229  



  Outcome Measures
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1.  Primary:   Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)   [ Time Frame: Up to Day 63 ]

2.  Secondary:   Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)   [ Time Frame: Up to Day 63 ]

3.  Secondary:   Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)   [ Time Frame: Up to Day 63 ]

4.  Secondary:   Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)   [ Time Frame: Up to Day 63 ]


  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: Therapeutic Areas Director
Organization: Jan-Cil Germany
phone: +49 2137 955-492


No publications provided


Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT00833560     History of Changes
Other Study ID Numbers: CR005242, 26866138MMY2031, 2005-003902-27
Study First Received: January 23, 2009
Results First Received: October 30, 2013
Last Updated: November 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission