A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
Completed · Phase 2 · Has a placebo group
Conditions studied: High-risk Smoldering Multiple Myeloma
In brief
The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).
Key facts
- Study ID
- NCT01484275
- Run by
- Janssen Research & Development, LLC
- People needed
- 85
- Starts
- 2012-03-01
- Expected to finish
- 2019-08-21
- Last updated by the study team
- 2020-01-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of smoldering multiple myeloma (SMM) for <4 years
- Diagnosis of 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)
- Patients must be within certain limits for protocol-specified laboratory tests
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
- Women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
- Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent
You may not qualify if…
- Having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
- Primary systemic amyloid light (AL) chain amyloidosis (a build-up of amyloid light chain proteins in the blood)
- Prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition; concurrent treatment with erythropoietin-stimulating agents (ESAs) are not allowed.)
- Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor
- Other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervix
Where it is running
- Study site — Chicago, Illinois, United States
- Study site — Rockville, Maryland, United States
- Study site — Detroit, Michigan, United States
- Study site — New York, New York, United States
- Study site — Kittanning, Pennsylvania, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Greenville, South Carolina, United States
- Study site — Dallas, Texas, United States
- Study site — Camperdown, Australia
- Study site — East Melbourne, Australia
- Study site — Randwick, Australia
- Study site — Antwerp, Belgium
- Study site — Brussels, Belgium
- Study site — Ghent, Belgium
- Study site — Dijon, France
- Study site — Nantes, France
- Study site — Tours, France
- Study site — Villejuif, France
- Study site — Berlin, Germany
- Study site — Hamburg, Germany
- Study site — Heidelberg, Germany
- Study site — Athens, Greece
- Study site — Ashkelon, Israel
- Study site — Jerusalem, Israel
- Study site — Nahariya, Israel
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.