Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Lymphatic Diseases

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Siltuximab

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

Placebo administered as a 1-hour infusion every 4 weeks + BSC

15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks

Administered as a 1-hour intravenous infusion every 4 weeks

Placebo

Best supportive care according to local standards and guidelines

Best supportive care (BSC)

Janssen Research & Development, LLC Clinical Trial

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).

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.

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.

Janssen Research & Development, LLC

Safety was analyzed for all randomized participants who received at least 1 dose of study medication.

Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)

Total

Age, Continuous

Sex: Female, Male

Australia

Belgium

Netherlands

Russian Federation

Spain

Sweden

United States

Region of Enrollment

DIRECTOR CLINICAL RESEARCH

Intent-to-treat population: Included all randomized participants

Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)

Intent-to-treat population: Included all randomized participants with evaluable data at Week 13

Change From Baseline in the Mean Hemoglobin Concentrations at Week 13

Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13

Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13

Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13

Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding

Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT01513317	Myelodysplastic...	Siltuximab Placebo Best supportive...	18 Years -	Janssen Research & Development, LLC
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	NCT01513317	Myelodysplastic...	Siltuximab Placebo Best supportive...	18 Years -	Janssen Research & Development, LLC

Spots Global Cancer Trial Database for blood and lymphatic diseases