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A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00401843
First received: November 17, 2006
Last updated: April 18, 2016
Last verified: April 2016
Results First Received: July 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Biological: Siltuximab
Drug: Bortezomib
Drug: Placebo
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
144 participants were randomized to bortezomib plus placebo group; of which, 3 participants received incorrect treatment (bortezomib plus siltuximab).

Reporting Groups
  Description
Part 1 - Bortezomib + Siltuximab Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
Part 2 - Bortezomib + Placebo

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.

Part 2 - Bortezomib + Siltuximab

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.

Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.


Participant Flow:   Overall Study
    Part 1 - Bortezomib + Siltuximab     Part 2 - Bortezomib + Placebo     Part 2 - Bortezomib + Siltuximab  
STARTED     21     144     142  
Treated     21     142     139  
COMPLETED     0     0     0  
NOT COMPLETED     21     144     142  
Achieved Complete Response                 1                 5                 11  
Adverse Event                 7                 26                 27  
Death                 0                 8                 10  
Disease progression                 10                 60                 49  
End of Study                 1                 1                 2  
Lost to Follow-up                 0                 0                 2  
Other Unspecified                 0                 3                 5  
Physician Decision                 0                 16                 10  
Protocol Violation                 0                 0                 1  
Withdrawal by Subject                 1                 5                 5  
Withdrawal of consent to study agent                 1                 15                 17  
Randomized but not Treated                 0                 2                 3  
Received incorrect treatment                 0                 3                 0  



  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
Part 1 - Bortezomib + Siltuximab Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
Part 2 - Bortezomib + Placebo

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.

Part 2 - Bortezomib + Siltuximab

Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.

Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.

Total Total of all reporting groups

Baseline Measures
    Part 1 - Bortezomib + Siltuximab     Part 2 - Bortezomib + Placebo     Part 2 - Bortezomib + Siltuximab     Total  
Number of Participants  
[units: participants]
  21     144     142     307  
Age  
[units: years]
Mean (Standard Deviation)
  66  (10.76)     62.3  (9.65)     63.5  (9.32)     63.1  (9.6)  
Gender  
[units: participants]
       
Female     13     59     70     142  
Male     8     85     72     165  
Region of Enrollment  
[units: participants]
       
Belgium     0     2     1     3  
Brazil     0     6     4     10  
Bulgaria     0     16     10     26  
Canada     3     4     5     12  
Czech Republic     0     13     11     24  
France     7     5     7     19  
Germany     0     1     1     2  
Greece     0     5     5     10  
Hungary     0     10     10     20  
Netherlands     2     4     5     11  
Poland     0     19     11     30  
Portugal     0     5     4     9  
Romania     0     8     5     13  
Russian Federation     0     21     27     48  
Spain     2     5     10     17  
United Kingdom     0     12     15     27  
United States     7     8     11     26  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Randomization until disease progression or death, which ever occured first (maximum up to 5 years) ]

2.  Primary:   Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: up to 5 years ]

3.  Secondary:   Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate)   [ Time Frame: Randomization until disease progression (maximum up to 5 years) ]

4.  Secondary:   Percentage of Participants With Confirmed Complete Response (CR Rate)   [ Time Frame: Randomization until disease progression (maximum up to 5 years) ]

5.  Secondary:   Overall Survival   [ Time Frame: up to 5 years ]


  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: Project Physician
Organization: Janssen R&D UK
e-mail: ClinicalTrialDisclosure@its.jnj.com


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

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00401843     History of Changes
Other Study ID Numbers: CR012784
C0328T06 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: November 17, 2006
Results First Received: July 7, 2015
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Great Britain: Medicines and Healthcare Products Regulatory Agency