A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT01484275 |
Recruitment Status
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Active, not recruiting
First Posted
: December 2, 2011
Last Update Posted
: February 5, 2018
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Tracking Information | ||||
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First Submitted Date ICMJE | December 1, 2011 | |||
First Posted Date ICMJE | December 2, 2011 | |||
Last Update Posted Date | February 5, 2018 | |||
Actual Study Start Date ICMJE | March 1, 2012 | |||
Estimated Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
One-year progression-free survival (PFS) rate [ Time Frame: 6 months after 74th participant is randomized ] Defined by CRAB - IMWG (calcium, renal, anemia, and bone lesions - International Myeloma Working Group) criteria.
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Original Primary Outcome Measures ICMJE |
One-year progression-free survival (PFS) rate [ Time Frame: One year after randomization of last patient ] Defined by CRAB - IMWG (calcium, renal, anemia, and bone lesions - International Myeloma Working Group) criteria.
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Change History | Complete list of historical versions of study NCT01484275 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma | |||
Official Title ICMJE | A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma | |||
Brief 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | High-risk Smoldering Multiple Myeloma | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
87 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Estimated Study Completion Date | August 31, 2019 | |||
Estimated Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Belgium, France, Germany, Greece, Israel, Korea, Republic of, Spain, Sweden, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01484275 | |||
Other Study ID Numbers ICMJE | CR100755 CNTO328SMM2001 ( Other Identifier: Janssen Research & Development, LLC ) 2011-001735-22 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | |||
Responsible Party | Janssen Research & Development, LLC | |||
Study Sponsor ICMJE | Janssen Research & Development, LLC | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Janssen Research & Development, LLC | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |