Phase 2 N=79 Randomized Quadruple-blind Treatment

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

Multicentric Castleman's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01024036 ↗

Enrolled (actual)

Serious AEs

24.1%

Results posted

Aug 2014

Primary outcome: Primary: Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review — 0; 34 Percentage of participants — p=0.0012

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Siltuximab (Drug); Placebo (Drug); Best Supportive Care (BSC) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review	0; 34	0.0012 sig
SECONDARY Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review	383.0	—
SECONDARY Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review	3.8; 37.7	0.0022 sig
SECONDARY Median Duration of Tumor Response - by Independent Radiology Review	70; 356	—
SECONDARY Time to Treatment Failure	134; NA	0.0084 sig
SECONDARY Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)	0; 61.3	0.0002 sig
SECONDARY Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)	0; 41.9	0.0195 sig
SECONDARY Percentage of Participants Who Discontinued Corticosteroids	11.1; 30.8	—
SECONDARY 6-year Survival Rate	79.5; 86.3	—
SECONDARY Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline	262; 85	—
SECONDARY Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline	22; 15	—
SECONDARY Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline	NA; 420	—

Summary

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

Eligibility Criteria

Inclusion Criteria

Measurable and symptomatic Multicentric Castleman's Disease
Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment

Exclusion Criteria

Human Immunodeficiency Virus or Human Herpes Virus-8 positive
Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease
Previous history of lymphoma
Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years
Concurrent medical condition or disease that may interfere with study participation
Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01024036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.