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The study is being conducted to demonstrate that CNTO 328 in combination with best supportive care is superior to best supportive care in terms of durable tumor and symptomatic response (reduction in tumor size and the symptoms for at least 18 weeks) and has an acceptable benefit risk profile in among patients with multicentric Castleman's disease.
CNTO 328 is an experimental drug that is not approved in any country. CNTO 328 is being tested to see if it may be useful in treating Multicentric Castleman's Disease. This study will compare the effects (both good and bad) of CNTO 328 to those of placebo. Placebo looks like the drug being studied but has no active ingredients (for example a sugar pill). The purpose of this study is to show that receiving CNTO 328 with best supportive care (BSC) will provide benefit compared to patients receiving BSC alone in patients with Multicentric Castleman's Disease (MCD). Safety assessments will be performed throughout the study and include laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of side effects. At predefined timepoints the efficacy will be assessed (measures of drug working). Also, blood levels of CNTO 328 will be studied. At the beginning of the study, two-thirds of patients (52 in total) will be randomly selected (like the flip of a coin) to receive the study drug CNTO328, while the remaining group (26 patients) will receive placebo. Patients who initially get placebo may be given study drug if their disease worsens. Patients will receive study drug (active or placebo) every 3 weeks until treatment failure, treatment discontinuation, withdrawal from study, or until 48 weeks after the last patient starts study treatment. Treatment in this study will end 48 weeks after the last patient starts treatment. If the patient is benefitting at the time of study end, patients may continue to receive treatment in an extension protocol. Patient follow up will occur 3 months after last dose of study drug along with survival follow up until the study ends including extension treatments. Patients will be randomly assigned to 2 treatment groups. Group A will receive placebo (intravenously,through the vein) plus best supportive care. Group B will receive 11 mg/kg of CNTO 328 (intravenously, through the vein) plus best supportive care. Both groups will receive treatment every 3 weeks for up to 48 weeks after the last patient starts study treatment. Patients who do not respond to placebo treatment may be eligible to be treated with CNTO 328 every 3 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
CNTO 328, Placebo
Published on BioPortfolio: 2014-08-27T03:17:37-0400
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