A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
Conditions
High-risk Smoldering Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
High-risk smoldering multiple myeloma, Multiple myeloma, Siltuximab
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Siltuximab Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
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).
Detailed Description
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 74 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Locations
Muscle Shoals, Alabama, United States
Status: Withdrawn
Little Rock, Arkansas, United States
Status: Withdrawn
Norwich, Connecticut, United States
Status: Withdrawn
Atlanta, Georgia, United States
Status: Withdrawn
Chicago, Illinois, United States
Status: Active, not recruiting
Westwood, Kansas, United States
Status: Withdrawn
Bethesda, Maryland, United States
Status: Withdrawn
Rockville, Maryland, United States
Status: Completed
Boston, Massachusetts, United States
Status: Withdrawn
Ann Arbor, Michigan, United States
Status: Withdrawn
Detroit, Michigan, United States
Status: Active, not recruiting
Jackson, Mississippi, United States
Status: Withdrawn
Saint Louis, Missouri, United States
Status: Withdrawn
Hackensack, New Jersey, United States
Status: Withdrawn
Albuquerque, New Mexico, United States
Status: Withdrawn
New York, New York, United States
Status: Recruiting
New York, New York, United States
Status: Withdrawn
Durham, North Carolina, United States
Status: Withdrawn
Cleveland, Ohio, United States
Status: Withdrawn
Columbus, Ohio, United States
Status: Withdrawn
Kittanning, Pennsylvania, United States
Status: Completed
Philadelphia, Pennsylvania, United States
Status: Active, not recruiting
Philadelphia, Pennsylvania, United States
Status: Withdrawn
Greenville, South Carolina, United States
Status: Recruiting
Germantown, Tennessee, United States
Status: Withdrawn
Nashville, Tennessee, United States
Status: Completed
Dallas, Texas, United States
Status: Recruiting
Houston, Texas, United States
Status: Withdrawn
Newport News, Virginia, United States
Status: Withdrawn
Madison, Wisconsin, United States
Status: Withdrawn
Sheboygan, Wisconsin, United States
Status: Withdrawn
Camperdown, Australia
Status: Recruiting
East Melbourne, Australia
Status: Active, not recruiting
Randwick, Australia
Status: Active, not recruiting
Antwerpen, Belgium
Status: Active, not recruiting
Brussels, Belgium
Status: Completed
Gent, Belgium
Status: Active, not recruiting
Dijon, France
Status: Completed
Nantes Cedex 1, France
Status: Completed
Tours, France
Status: Recruiting
Villejuif, France
Status: Recruiting
Berlin, Germany
Status: Recruiting
Duisburg, Germany
Status: Withdrawn
Hamburg, Germany
Status: Recruiting
Heidelberg, Germany
Status: Recruiting
Mainz, Germany
Status: Withdrawn
Münster, Germany
Status: Withdrawn
Würzburg, Germany
Status: Withdrawn
Athens, Greece
Status: Completed
Ashkelon, Israel
Status: Active, not recruiting
Haifa, Israel
Status: Withdrawn
Jerusalem, Israel
Status: Active, not recruiting
Nahariya, Israel
Status: Active, not recruiting
Netanya, Israel
Status: Active, not recruiting
Petach Tikva, Israel
Status: Active, not recruiting
Tel Aviv, Israel
Status: Completed
Daejeon, Korea, Republic of
Status: Recruiting
Seongnam, Korea, Republic of
Status: Suspended
Seoul, Korea, Republic of
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Barcleona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
Valencia, Spain
Status: Recruiting
Göteborg, Sweden
Status: Completed
Linkoping, Sweden
Status: Completed
Malmö, Sweden
Status: Withdrawn
Stockholm, Sweden
Status: Completed
Uppsala, Sweden
Status: Withdrawn
Glasgow, United Kingdom
Status: Withdrawn
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Withdrawn
London, United Kingdom
Status: Active, not recruiting
Manchester, United Kingdom
Status: Active, not recruiting
Nottingham, United Kingdom
Status: Withdrawn
Start Date
March 2012
Completion Date
April 2016
Sponsors
Janssen Research & Development, LLC
Source
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page