Clinical trial · Interventional
A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Siltuximab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- description
- Siltuximab 15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years.
- interventionNames
- Biological: Siltuximab
Primary outcomes (1)
- measure
- QTc interval
- timeFrame
- Screening through Week 10
Secondary outcomes (3)
- measure
- Additional safety evaluations
- timeFrame
- 6 months and, if eligible, up to 2 years of extended treatment
- measure
- Efficacy evaluations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of MGUS (measurable serum M-protein \< 3 g/dL AND clonal bone marrow plasma cells \< 10% without any end organ damage), SMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% without any end organ damage) or IMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% and = 3 lytic bone lesions but no other end organ damage) * Qualifying ECG results that will be checked by a central laboratory * Negative urine drug screen for substances of abuse * Qualifying hematology and chemistry laboratory results. Exclusion Criteria: * Diagnosis of symptomatic multiple myeloma * Prior exposure to approved or investigational myeloma treatments * Prior exposure to agents targeting IL-6 or the IL-6 receptor * Significant cardiac disease * Skin condition likely to interfere with ECG electrode placement, breast implant, or thoracic surgery * Received medications known to affect the QT interval * Vaccination with live, attenuated vaccines within 4 weeks * Major surgery or radiation within 4 weeks
References
Publications (0)
Data not yet available