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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Myelodysplastic Syndrome

In brief

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).

Key facts

Study ID

NCT01513317

Run by

Janssen Research & Development, LLC

People needed

76

Starts

2011-11-01

Expected to finish

2012-09-01

Last updated by the study team

2014-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]).

You may not qualify if…

• 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.

Where it is running

• Study site — Tampa, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Box Hill, Australia
• Study site — Camperdown, Australia
• Study site — St Leonards, Australia
• Study site — Antwerp, Belgium
• Study site — Bruges, Belgium
• Study site — Ghent, Belgium
• Study site — Yvoir, Belgium
• Study site — Dordrecht, Netherlands
• Study site — The Hague, Netherlands
• Study site — Krasnodar, Russia
• Study site — Moscow, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Barcelona, Spain
• Study site — Madrid, Spain
• Study site — Oviedo (Asturias), Spain
• Study site — Salamanca, Spain
• Study site — Valencia, Spain
• Study site — Stockholm, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.