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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01024036




Registration number
NCT01024036
Ethics application status
Date submitted
30/11/2009
Date registered
2/12/2009
Date last updated
21/03/2018

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
Scientific title
A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease
Secondary ID [1] 0 0
CNTO328MCD2001
Secondary ID [2] 0 0
CR016705
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multicentric Castleman's Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Siltuximab
Treatment: Drugs - Placebo
Treatment: Drugs - Best Supportive Care (BSC)

Experimental: Siltuximab+best supportive care (BSC) - Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC.

Placebo comparator: Placebo+BSC - Placebo will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. Participants who do not respond to placebo during the blinded treatment period will have option to crossover and receive siltuximab 11 mg/kg which will be administered by 1-hour intravenous infusion every 3 weeks + BSC during the unblinded treatment period.


Treatment: Drugs: Siltuximab
Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks

Treatment: Drugs: Placebo
Placebo will be administered by 1-hour intravenous infusion every 3 weeks

Treatment: Drugs: Best Supportive Care (BSC)
BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review
Timepoint [1] 0 0
From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier
Secondary outcome [1] 0 0
Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review
Timepoint [1] 0 0
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 (approximately 3 years)
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review
Timepoint [2] 0 0
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 (approximately 3 years)
Secondary outcome [3] 0 0
Median Duration of Tumor Response - by Independent Radiology Review
Timepoint [3] 0 0
From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)
Secondary outcome [4] 0 0
Time to Treatment Failure
Timepoint [4] 0 0
From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)
Timepoint [5] 0 0
Week 13
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)
Timepoint [6] 0 0
Week 13
Secondary outcome [7] 0 0
Percentage of Participants Who Discontinued Corticosteroids
Timepoint [7] 0 0
From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)
Secondary outcome [8] 0 0
6-year Survival Rate
Timepoint [8] 0 0
until 6 years
Secondary outcome [9] 0 0
Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline
Timepoint [9] 0 0
From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
Secondary outcome [10] 0 0
Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline
Timepoint [10] 0 0
From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
Secondary outcome [11] 0 0
Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline
Timepoint [11] 0 0
From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)

Eligibility
Key inclusion criteria
* Measurable and symptomatic Multicentric Castleman's Disease
* Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Human Immunodeficiency Virus or Human Herpes Virus-8 positive
* Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease
* Previous history of lymphoma
* Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years
* Concurrent medical condition or disease that may interfere with study participation
* Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2017
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Massachusetts
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United States of America
State/province [5] 0 0
Michigan
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United States of America
State/province [6] 0 0
Minnesota
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United States of America
State/province [7] 0 0
North Carolina
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United States of America
State/province [8] 0 0
South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Belgium
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Brussels
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Belgium
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Leuven
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Brazil
State/province [14] 0 0
Brasilia
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Brazil
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Porto Alegre
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Canada
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Toronto
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China
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Beijing
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China
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Chengdu
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China
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Guangzhou
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China
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Hangzhou
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China
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Shanghai
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Egypt
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Cairo
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France
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Clermont Ferrand
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France
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Grenoble Cedex 1
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France
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Lille Cedex
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France
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Montpellier
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France
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Paris
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France
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Rennes
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France
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Tours Cedex 9
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Mainz
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Germany
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München
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Hong Kong
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Sha Tin
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Hungary
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Budapest
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India
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Hyderabad N/A
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India
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Pune
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Korea, Republic of
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Seoul
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Malaysia
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Pandan
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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Norway
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Oslo
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St.-Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taipei
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United Kingdom
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London
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United Kingdom
State/province [56] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01024036