A 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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000261-12-BE

Enrollment

Registered

2011-06-27

Start date

2011-09-28

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia associated with Low- or Intermediate-1-Risk Myelodysplastic Syndrome MedDRA version: 14.1 Level: LLT Classification code 10028534 Term: Myelodysplastic syndrome NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Siltuximab Product Code: CNTO328 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Siltuximab Current Sponsor code: CNTO328 Other descriptive name: Chimeric muri

Eligibility

Sex/Gender

All

Inclusion 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]). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the clinical efficacy of siltuximab, demonstrated by a reduction in RBC transfusions to treat the anemia of MDS.;Secondary Objective: • To demonstrate symptomatic improvement of subjects treated with siltuximab compared with the placebo group • To compare the number of RBC units transfused to treat the anemia of MDS, and the proportion of subjects treated with siltuximab who do not require a RBC transfusion to treat the anemia of MDS, from Week 5 to Week 12, compared with the placebo group • To assess the change in hemoglobin among MDS subjects treated with siltuximab compared with the placebo group • To compare disease progression (proportion of bone marrow blasts and cytogenetic change) for subjects treated with siltuximab compared with the placebo group • To assess the safety profile of siltuximab and RBC transfusions among subjects with Low- or Intermediate-1 (INT-1)-risk MDS • To assess the pharmacodynamics, pharmacokinetics, and antibodies to siltuximab (immunogenicity) in MDS subjects •See protocol for additional objectives;Primary end point(s): Proportion of patients achieving a reduction in RBC transfusions;Timepoint(s) of evaluation of this end point: 8 week period from week 5 to week 12	—

Measure

Time frame

Main Objective: The primary objective is to assess the clinical efficacy of siltuximab, demonstrated by a reduction in RBC transfusions to treat the anemia of MDS.;Secondary Objective: • To demonstrate symptomatic improvement of subjects treated with siltuximab compared with the placebo group • To compare the number of RBC units transfused to treat the anemia of MDS, and the proportion of subjects treated with siltuximab who do not require a RBC transfusion to treat the anemia of MDS, from Week 5 to Week 12, compared with the placebo group • To assess the change in hemoglobin among MDS subjects treated with siltuximab compared with the placebo group • To compare disease progression (proportion of bone marrow blasts and cytogenetic change) for subjects treated with siltuximab compared with the placebo group • To assess the safety profile of siltuximab and RBC transfusions among subjects with Low- or Intermediate-1 (INT-1)-risk MDS • To assess the pharmacodynamics, pharmacokinetics, and antibodies to siltuximab (immunogenicity) in MDS subjects •See protocol for additional objectives;Primary end point(s): Proportion of patients achieving a reduction in RBC transfusions;Timepoint(s) of evaluation of this end point: 8 week period from week 5 to week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Hemoglobin Assessment 2. Bone Marrow Examination 3. Anemia Symptom Assessment;Timepoint(s) of evaluation of this end point: 1. At Week 12 2. At Week 13 and every 24 weeks during treatment 3. Daily for 12 weeks, then monthly for remainder of treatment period	—

Countries

Australia, Belgium, Netherlands, Russian Federation, Spain, Sweden, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International N.V.

ClinicalTrialsEU@jnj.its.com31071 524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026