Velcade Consolidation Bone Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01286077
First received: January 27, 2011
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: November 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: bortezomib

  Participant Flow
  Hide Participant Flow

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
Bortezomib bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control no treatment, observation only

Participant Flow:   Overall Study
    Bortezomib     Non-treated Control  
STARTED     51 [1]   53 [2]
COMPLETED     41     46  
NOT COMPLETED     10     7  
Adverse Event                 2                 0  
Death                 1                 0  
Protocol Violation                 1                 1  
Withdrawal by Subject                 0                 2  
Intercurrent illness                 1                 0  
Non-compliance                 1                 0  
The subject starts with alternative MMY                 0                 3  
Patient's decision to stop treatment                 3                 0  
Progression of disease                 0                 1  
refill medication not received in time                 1                 0  
[1] One patient did not start treatment and was excluded from the Intent to Treat (ITT) population.
[2] One patient did not have any post-baseline assessment and was excluded from the ITT population.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Bortezomib bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control no treatment, observation only
Total Total of all reporting groups

Baseline Measures
    Bortezomib     Non-treated Control     Total  
Number of Participants  
[units: participants]
  51     53     104  
Age  
[units: years]
Mean ( Full Range )
  56.7  
  ( 27 to 75 )  
  54.7  
  ( 35 to 73 )  
  55.7  
  ( 27 to 75 )  
Gender  
[units: participants]
     
Female     18     22     40  
Male     33     31     64  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)   [ Time Frame: at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier ]

2.  Primary:   Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment   [ Time Frame: at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier ]

3.  Secondary:   Progression Free Survival   [ Time Frame: until 18 months after end of treatment (approximately 24 months after randomization) ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

4.  Secondary:   Change From Baseline in Biochemical Bone Markers   [ Time Frame: baseline, Day 1 of cycle 3, EOT visit (24 weeks after randomization or until start of alternative MMY therapy, if earlier) and 4, 6, 12 and 18 months after EOT ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

5.  Secondary:   Skeletal Events   [ Time Frame: At each visit from screening to 18 months after EOT (approximately 24 months after randomization) ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

6.  Secondary:   Appearance of New Bone Lesions Compared to Baseline   [ Time Frame: at screening, EOT (24 weeks after randomization or until start of alternative MMY therapy, if earlier) and 18 months after EOT ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

7.  Secondary:   Change From Baseline in BMD Over Time   [ Time Frame: at Day 1 of Cycle 3 or Day 71 in the observation arm, and and 6, 12 and 18 months after EOT ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

8.  Secondary:   Karnofsky Performance Status   [ Time Frame: at screening, Day 1 of Cycle 2, 3, and 4 or Day 36, 71 and 106 for observation arm, at EOT Visit, and and 4, 6, 12 and 18 months after EOT or start of alternative MMY therapy, if earlier ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

9.  Secondary:   Overall Survival   [ Time Frame: until 18 months after EOT (approximately 24 months after randomization) ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: EMEA Medical Affairs Director
Organization: Janssen-Cilag Greece
phone: +30 210 8090738


No publications provided


Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01286077     History of Changes
Other Study ID Numbers: CR016270, 26866138MMY2060, 2008-004264-39
Study First Received: January 27, 2011
Results First Received: November 7, 2013
Last Updated: May 21, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment