A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Summary

The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).

Timeline

Start

2011-11

Primary completion

2012-09

Completion

2012-09

Outcome

Missed primary endpoint

Stopped: “The study was stopped after the interim analysis based on lack of sufficient efficacy. There were no safety concerns.”

registry analysis (superiority or other test); Siltuximab vs Placebo; p = 0.271; Difference in proportions 0.082 (95% CI -0.03 to 0.20); Cochran-Mantel-Haenszel NCT01513317 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Siltuximab	Monoclonal antibody	15 mg/kg	Intravenous

Indications