Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome MDS Blood and lymphatic diseases Siltuximab Anemic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

Brief 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).

Detailed description:
The study treatments will be administered double-blind for 12 weeks, meaning that the patient and study personnel will not know the identity of the treatment. Approximately 75 patients will be randomized (patients are assigned to a treatment by a chance) in a 2:1 ratio to receive siltuximab plus best supportive care (BSC) (Group A) or placebo plus BSC (Group B). BSC includes RBC transfusion, antimicrobials, white blood cell (WBC) growth factors, and platelet transfusions. Patients who complete 12 weeks of treatment may qualify to receive siltuximab as open-label (identity of treatment will be known) treatment. Treatment may continue until death, unacceptable toxicity, withdrawal of consent, or the clinical cutoff (defined as 24 weeks after the last patient is randomized), whichever occurs first. The study will end approximately 36 weeks after the last patient is randomized. Patient safety will be monitored. Siltuximab and matching placebo will be supplied as a sterile, lyophilized formulation for reconstitution and intravenous (IV) infusion. Group A: siltuximab (15 mg/kg) administered as a 1-hour infusion every 4 weeks + BSC, or Group B: placebo administered as a 1-hour infusion every 4 weeks + BSC.

Arms:
arm 1: 15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC) arm 2: Placebo administered as a 1-hour infusion every 4 weeks + BSC

Interventions: intervention 1: Siltuximab intervention 2: Placebo intervention 3: Best supportive care (BSC)
Intervention descriptions: intervention 1: 15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks intervention 2: Administered as a 1-hour intravenous infusion every 4 weeks intervention 3: Best supportive care according to local standards and guidelines

Protocol document: