A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Multicentric Castleman's Disease

Treatments: Drug: Placebo; Drug: Best Supportive Care (BSC); Drug: Siltuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024036

CR016705

2009-012380-34 (EudraCT Number)

CNTO328MCD2001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

Full description

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double blind (neither investigator nor the participant knows the treatment that the participant receives), placebo controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), study to assess the efficacy and safety of CNTO 328 plus BSC compared with BSC in patients with symptomatic Multicentric Castleman's Disease. The study mainly consists of 3 phases, including: the screening phase (majority of assessments performed within 28 days of first dose), the treatment phase (blinded and unblinded), and the follow up phase. In the blinded treatment phase, approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment groups, ie, Placebo + BSC, or CNTO 328 + BSC. Participants receiving placebo + BSC during blinded treatment period who do not respond and have treatment failure will have the option to crossover and receive siltuximab + BSC during unbllinded treatent period. The follow up phase will be 3 months after last dose of study medication and the survival will be followed up until the study ends. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical examination will be monitored throughout the study. The total study duration will be 5 years after the last patient starts study medication.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

Siltuximab+best supportive care (BSC)

Experimental group

Description:

Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC.

Treatment:

Drug: Siltuximab

Drug: Best Supportive Care (BSC)

Placebo+BSC

Placebo Comparator group

Description:

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:

Drug: Placebo

Drug: Best Supportive Care (BSC)