Phase 2
N=85
A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
High-risk Smoldering Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01484275 ↗Enrolled (actual)
85
Serious AEs
30.6%
Results posted
Jan 2020
Primary outcome: Primary: One-Year Progression-Free Survival (PFS) Rate — 84.5; 74.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Siltuximab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One-Year Progression-Free Survival (PFS) Rate |
84.5; 74.4 | — |
| SECONDARY Progressive Disease Indicator Rate (PDIR) at 6 Months |
30.2; 42.9 | — |
| SECONDARY Progression-Free Survival |
NA; 715.0 | — |
| SECONDARY Percentage of Participants With Serum M-protein Response |
2.3; 0.0 | — |
| SECONDARY Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score |
125.50; 118.00 | — |
| SECONDARY Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores |
652.0; 453.0 | — |
| SECONDARY Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features |
— | — |
| SECONDARY Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment |
— | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of smoldering multiple myeloma (SMM) for =10% and either serum monoclonal protein >=3 g/dL, or abnormal free light chain ratio 8 and serum M-protein =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
Data sourced from ClinicalTrials.gov (NCT01484275). 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.