A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
NCT ID: NCT01024036
Last Updated: 2018-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2010-03-18
2017-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Siltuximab+best supportive care (BSC)
Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC.
Siltuximab
Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks
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.
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.
Placebo
Placebo will be administered by 1-hour intravenous infusion every 3 weeks
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.
Interventions
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Siltuximab
Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks
Placebo
Placebo will be administered by 1-hour intravenous infusion every 3 weeks
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Little Rock, Arkansas, United States
Los Angeles, California, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
Lansing, Michigan, United States
Rochester, Minnesota, United States
Chapel Hill, North Carolina, United States
Greenville, South Carolina, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
East Melbourne, , Australia
Brussels, , Belgium
Leuven, , Belgium
Brasília, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Toronto, , Canada
Beijing, , China
Chengdu, , China
Guangzhou, , China
Hangzhou, , China
Shanghai, , China
Cairo, , Egypt
Clermont-Ferrand, , France
Grenoble, , France
Lille, , France
Montpellier, , France
Paris, , France
Rennes, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Mainz, , Germany
München, , Germany
Shatin, , Hong Kong
Budapest, , Hungary
Hyderabad, , India
Pune, , India
Petah Tikva, , Israel
Ramat Gan, , Israel
Pandan, , Malaysia
Rotterdam, , Netherlands
Auckland, , New Zealand
Oslo, , Norway
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Taipei, , Taiwan
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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van Rhee F, Rosenthal A, Kanhai K, Martin R, Nishimura K, Hoering A, Fajgenbaum DC. Siltuximab is associated with improved progression-free survival in idiopathic multicentric Castleman disease. Blood Adv. 2022 Aug 23;6(16):4773-4781. doi: 10.1182/bloodadvances.2022007112.
Fajgenbaum DC, Uldrick TS, Bagg A, Frank D, Wu D, Srkalovic G, Simpson D, Liu AY, Menke D, Chandrakasan S, Lechowicz MJ, Wong RS, Pierson S, Paessler M, Rossi JF, Ide M, Ruth J, Croglio M, Suarez A, Krymskaya V, Chadburn A, Colleoni G, Nasta S, Jayanthan R, Nabel CS, Casper C, Dispenzieri A, Fossa A, Kelleher D, Kurzrock R, Voorhees P, Dogan A, Yoshizaki K, van Rhee F, Oksenhendler E, Jaffe ES, Elenitoba-Johnson KS, Lim MS. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood. 2017 Mar 23;129(12):1646-1657. doi: 10.1182/blood-2016-10-746933. Epub 2017 Jan 13.
van Rhee F, Wong RS, Munshi N, Rossi JF, Ke XY, Fossa A, Simpson D, Capra M, Liu T, Hsieh RK, Goh YT, Zhu J, Cho SG, Ren H, Cavet J, Bandekar R, Rothman M, Puchalski TA, Reddy M, van de Velde H, Vermeulen J, Casper C. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014 Aug;15(9):966-74. doi: 10.1016/S1470-2045(14)70319-5. Epub 2014 Jul 17.
Other Identifiers
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CNTO328MCD2001
Identifier Type: OTHER
Identifier Source: secondary_id
2009-012380-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR016705
Identifier Type: -
Identifier Source: org_study_id
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