Trial record 1 of 1 for:    MCD2001
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A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01024036
First received: November 30, 2009
Last updated: August 1, 2014
Last verified: August 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multicentric Castleman's Disease
Interventions: Drug: Siltuximab
Drug: Placebo
Drug: Best Supportive Care (BSC)

  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
79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data for the primary analysis is presented here.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.

Reporting Groups
  Description
Siltuximab + Best Supportive Care (BSC) 11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
Placebo + Best Supportive Care (BSC) Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC

Participant Flow for 2 periods

Period 1:   Blinded Treatment
    Siltuximab + Best Supportive Care (BSC)     Placebo + Best Supportive Care (BSC)  
STARTED     53     26  
COMPLETED     31     6  
NOT COMPLETED     22     20  
Adverse Event                 1                 1  
Lack of Efficacy                 16                 14  
Physician Decision                 1                 0  
Death                 0                 2  
Withdrawal by Subject                 4                 3  

Period 2:   Unblinded Treatment
    Siltuximab + Best Supportive Care (BSC)     Placebo + Best Supportive Care (BSC)  
STARTED     13 [1]   0 [2]
COMPLETED     10     0  
NOT COMPLETED     3     0  
Adverse Event                 1                 0  
Lack of Efficacy                 2                 0  
[1] Only 13 participants from Placebo+BSC group received siltuximab+BSC in unblinded treatment period
[2] No participants received Placebo+BSC during unblinded treatment period



  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
Siltuximab + Best Supportive Care (BSC) 11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
Placebo + Best Supportive Care (BSC) Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
Total Total of all reporting groups

Baseline Measures
    Siltuximab + Best Supportive Care (BSC)     Placebo + Best Supportive Care (BSC)     Total  
Number of Participants  
[units: participants]
  53     26     79  
Age  
[units: years]
Mean ± Standard Deviation
  44.4  ± 13.32     47.7  ± 13.4     45.5  ± 13.35  
Gender  
[units: participants]
     
Female     23     4     27  
Male     30     22     52  
Region of Enrollment  
[units: participants]
     
AUSTRALIA     1     0     1  
BELGIUM     3     0     3  
BRAZIL     4     2     6  
CANADA     0     1     1  
CHINA     11     5     16  
EGYPT     0     1     1  
FRANCE     2     2     4  
GERMANY     0     1     1  
HONG KONG     3     2     5  
ISRAEL     1     1     2  
NEW ZEALAND     1     1     2  
NORWAY     1     1     2  
RUSSIAN FEDERATION     3     0     3  
SINGAPORE     3     0     3  
SOUTH KOREA     4     2     6  
SPAIN     1     1     2  
TAIWAN     3     1     4  
UNITED KINGDOM     2     1     3  
UNITED STATES     10     4     14  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from the study, or up to 48 weeks after the last participant started study medication, whichever occurred earlier ]

2.  Secondary:   Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment ]

3.  Secondary:   Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review   [ Time Frame: From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment ]

4.  Secondary:   Median Duration of Tumor Response - by Independent Radiology Review   [ Time Frame: From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment ]

5.  Secondary:   Time to Treatment Failure   [ Time Frame: From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment, whichever occurred earlier ]

6.  Secondary:   Percentage of Participants Who Achieved >= 15 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

7.  Secondary:   Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

8.  Secondary:   Percentage of Participants Who Discontinued Corticosteroids   [ Time Frame: From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment ]

9.  Secondary:   1-year Survival Rate   [ Time Frame: 1 year ]

10.  Secondary:   Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]

11.  Secondary:   Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]

12.  Secondary:   Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment ]


  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: DIRECTOR CLINICAL RESEARCH
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01024036     History of Changes
Other Study ID Numbers: CR016705, CNTO328MCD2001, 2009-012380-34
Study First Received: November 30, 2009
Results First Received: May 16, 2014
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Taiwan: Department of Health