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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: April 26, 2016
Last verified: April 2016
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
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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
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
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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
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 
Overall Participants Analyzed 
[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
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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: Baseline up to end of study (approximately 4 years 7 months) ]

4.  Secondary:   Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

5.  Secondary:   Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

6.  Secondary:   Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

7.  Secondary:   Number of Patients With Skeletal Events   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

8.  Secondary:   Appearance of New Bone Lesions Compared to Baseline   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

9.  Secondary:   Change From Baseline in Spine T-score   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

10.  Secondary:   Karnofsky Performance Status   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

11.  Secondary:   Overall Survival   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

12.  Secondary:   Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

13.  Secondary:   Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

14.  Secondary:   Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria   [ Time Frame: Baseline up to end of study (approximately 4 years 7 months) ]

15.  Secondary:   Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria   [ Time Frame: Baseline up to end of study (approximately 4 years 7 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 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



Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01286077     History of Changes
Other Study ID Numbers: CR016270
26866138MMY2060 ( Other Identifier: Janssen-Cilag International NV )
2008-004264-39 ( EudraCT Number )
Study First Received: January 27, 2011
Results First Received: November 7, 2013
Last Updated: April 26, 2016
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment