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

NCT ID: NCT01513317

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-09-30

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.

Conditions

Myelodysplastic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Siltuximab

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

Group Type: EXPERIMENTAL

Siltuximab

Intervention Type: DRUG

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

Best supportive care (BSC)

Intervention Type: DRUG

Best supportive care according to local standards and guidelines

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Administered as a 1-hour intravenous infusion every 4 weeks

Best supportive care (BSC)

Intervention Type: DRUG

Best supportive care according to local standards and guidelines

Interventions

Siltuximab

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

Intervention Type: DRUG

Placebo

Administered as a 1-hour intravenous infusion every 4 weeks

Intervention Type: DRUG

Best supportive care (BSC)

Best supportive care according to local standards and guidelines

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of myelodysplastic syndrome (MDS), according to World Heath Organization or the French-American-British Cooperative Group pathologic classification, with an International Prognostic Scoring System score 0, 0.5, or 1.0, indicating Low- or INT-1-risk disease.
• Documented RBC transfusion of at least 2 units of RBC for the treatment of the anemia of MDS in the 8 weeks preceding the start of the Screening Period.
• Adequate iron stores, demonstrated by either the presence of stainable iron in the bone marrow or a serum ferritin of > 100 ng/mL.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
• Symptomatic anemia (defined by a score > 0 on the Non-Chemotherapy Anemia Symptom Scale [NCA-SS]).

Exclusion Criteria

• Had treatment with drugs or other agents targeting IL-6 or its receptor within 4 weeks of randomization.
• Any condition that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
• Patients with Chronic Myelomonocytic Leukemia (CMML).
• Causes other than MDS contributing to anemia, such as Vitamin B12 or folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic renal failure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Tampa, Florida, United States

Boston, Massachusetts, United States

New York, New York, United States

Winston-Salem, North Carolina, United States

Houston, Texas, United States

Box Hill, , Australia

Camperdown, , Australia

St Leonards, , Australia

Antwerp, , Belgium

Bruges, , Belgium

Ghent, , Belgium

Yvoir, , Belgium

Dordrecht, , Netherlands

The Hague, , Netherlands

Krasnodar, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Barcelona, , Spain

Madrid, , Spain

Oviedo (Asturias), , Spain

Salamanca, , Spain

Valencia, , Spain

Stockholm, , Sweden

Countries

United States; Australia; Belgium; Netherlands; Russia; Spain; Sweden

Other Identifiers

CNTO328MDS2001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-000261-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100752

Identifier Type: -

Identifier Source: org_study_id