PARAMETER

DATA

Manufacturer

Janssen Biotech, Inc.

Indication

SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Cell Substrate

Human/murine chimeric immunoglobulin G1κ (IgG1κ) monoclonal antibody against human interleukin-6 (hIL-6) produced in a Chinese Hamster Ovary (CHO) cell line.

Manufacturing platform

Siltuximab active substance Final Bulk (FB) is manufactured in a 9-stage process. Briefly, the active substance is obtained by several purification steps (protein A, cation exchange and anion exchange chromatography) from the harvests of one or more CHO cell line bioreactor culture(s). The FB is stored frozen at -40 °C until further processing into the final lyophilized product.

Dose in vial/final container

• 100 mg of lyophilized powder in a single-use vial.
• 400 mg of lyophilized powder in a single-use vial.

Dose to patient

Administer as an 11 mg/kg dose given over 1 hour by intravenous infusion every 3 weeks.

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

Summary of clinical studies in patients with Castleman’s Disease

NCT01024036

2

79

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

United States, Australia, China, Belgium, Brazil, Canada, Egypt, France, Hong Kong, Germany, Hungary, India, Israel, Korea, Republic of, Norway, Malaysia, Spain, Netherlands, New Zealand, Russian Federation, Taiwan, Singapore, United Kingdom

NCT00412321

1

67

A Safety and Efficacy Study of CNTO 328 in Patients with B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

United States

NCT01400503

2

60

A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's Disease

United States, Belgium, Brazil, Canada, China, Egypt, France, Hong Kong, Germany, Israel, Korea, Republic of, Norway, New Zealand, Taiwan, Singapore, United Kingdom, Spain

Summary of clinical studies in Healthy Volunteers

NCT02074800

1

145

A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants

United States

Summary of clinical studies in patients with Hematologic Malignancies other than Castleman’s Disease

NCT00402181

2

53

An Efficacy and Safety Study of Siltuximab in Participants with Relapsed or Refractory Multiple Myeloma

United States, Netherlands

NCT00401843

2

307

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients with Relapsed or Refractory Multiple Myeloma

United States, Belgium, Brazil, Bulgaria, Spain, Canada, Czechia, France, Germany, Greece, Hungary, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, United Kingdom

NCT00911859

2

118

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) with VMP Alone in Previously Untreated Multiple Myeloma Patients

United States, France, Australia, India, Israel, Korea, Republic of, Poland, Romania, Russian Federation, Singapore, Spain

NCT01219010

1

30

A Study Evaluating the Effects of Siltuximab on the Heart in Patients with Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

United States, Belgium, Russian Federation

NCT01513317

2

76

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

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

NCT01309412

1

9

A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma

Japan

Summary of clinical studies in patients with Solid Tumors

NCT00265135

1, 2

68

A Study of CNTO 328 in Subjects with Metastatic Renal Cell Carcinoma

Czech Republic, France, Netherlands, United Kingdom

NCT00401765

1

40

A Study of CNTO 328 in Patients with Metastatic Hormone-Refractory Prostate Cancer

United States

NCT00841191

1, 2

84

A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants with Solid Tumors

United States, Belgium, France, Spain, United Kingdom

NCT00385827

2

106

A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects with Metastatic Hormone-Refractory Prostate Cancer (HRPC)

United States, Belgium, Austria, France, Spain, Germany, United Kingdom