Clinical trial NCT01024036
Conditions: Multicentric Castleman's Disease
Keywords: Multicentric Castleman's Disease MCD CNTO 328 Best Supportive Care Tumor Symptomatic response Pharmacokinetics Interleukin-6 IL6
Sponsor: Janssen Research & Development, LLC
Start date: 2010-03-18; Completion date: 2017-02-24
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed 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.

Arms: arm 1: Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. arm 2: 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.
Interventions: intervention 1: Siltuximab intervention 2: Placebo intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks intervention 2: Placebo will be administered by 1-hour intravenous infusion every 3 weeks intervention 3: BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.

Protocol documents: