A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma
This is a randomized (treatment assigned by chance), double-blind (neither patient nor
investigator know which treatment is given), multicenter study to evaluate the safety and
efficacy of siltuximab compared with placebo in patients with high-risk SMM (defined as bone
marrow plasma cells >=10% and either serum monoclonal protein >=3 g/dL, or abnormal free
light chain ratio <0.126 or >8 and serum M-protein <3 g/dL but >=1 g/dL). Approximately 100
patients will receive either siltuximab or placebo by intravenous (IV, injection into a
vein) infusion every 4 weeks until progression to symptomatic multiple myeloma, unacceptable
toxicity, withdrawal of consent, or the end of the study (approximately 4 years after
randomization of the last patient). Efficacy, pharmacokinetics, immunogenicity, and
potential biomarkers will be assessed at time points defined in the protocol. Patient
reported outcomes (European Organization for Research and Treatment of Cancer, Quality of
Life Questionnaire-Core 30, Brief Pain Inventory [worst pain], Non-Chemotherapy Anemia
Symptom Scale) will be administered before any procedure or treatment at each visit. Patient
safety will be monitored throughout the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
One-year progression-free survival (PFS) rate
Defined by CRAB - IMWG (calcium, renal, anemia, and bone lesions - International Myeloma Working Group) criteria.
One year after randomization of last patient
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100755
NCT01484275
March 2012
April 2015
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Birmingham, Alabama 35294 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
McLean, Virginia 22101 | |
Little Rock, Arkansas 72205-7199 | |
Kansas City, Kansas 66160 | |
Albuquerque, New Mexico 87131-5636 | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Milwaukee, Wisconsin | |
Charleston, South Carolina | |
Jackson, Mississippi |