Testing linvoseltamab for eliminating abnormal plasma cells in patients with high-risk MGUS or smoldering multiple myeloma
Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
This study is testing if a new drug called linvoseltamab can help get rid of abnormal plasma cells in patients with high-risk MGUS or smoldering multiple myeloma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | linvoseltamab |
| Locations | 20 sites (Baltimore, Maryland and 19 other locations) |
| Trial ID | NCT06140524 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of linvoseltamab in eliminating abnormal plasma cells associated with high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non-high-risk smoldering multiple myeloma (NHR-SMM). Participants will receive gradually increasing doses of the drug to assess its tolerability and short-term side effects in the first five weeks. The study is divided into two parts, with the first part focusing on dose evaluation and the second part on further treatment assessment. The overall goal is to determine if linvoseltamab can effectively reduce the presence of abnormal plasma cells in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with high-risk MGUS or non-high-risk smoldering multiple myeloma.
Not a fit: Patients with high-risk smoldering multiple myeloma or those with symptomatic multiple myeloma will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could potentially prevent the progression of high-risk MGUS and smoldering multiple myeloma to symptomatic multiple myeloma.
How similar studies have performed: While this approach is novel, similar studies targeting plasma cell disorders have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. HR-MGUS or NHR-SMM as defined in the protocol 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 3. Adequate hematologic and hepatic function, as described in the protocol 4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation Key Exclusion Criteria: 1. High-risk SMM, as defined in the protocol 2. Evidence of any of myeloma-defining events, as described in the protocol 3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM 4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol 5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab 6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply
Where this trial is running
Baltimore, Maryland and 19 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Michigan Health — Ann Arbor, Michigan, United States (Recruiting)
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Algemeen Ziekenhuis (AZ) Klina — Brasschaat, Antwerpen, Belgium (Recruiting)
- Algemeen Ziekenhuis AZ Delta — Roeselare, West-Vlaanderen, Belgium (Recruiting)
- Cork University Hospital — Cork, Ireland (Recruiting)
- Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori — Meldola, Forli-Cesena, Italy (Recruiting)
- San Paolo Hospital — Milan, Lombardy, Italy (Recruiting)
- Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital — Torun, Kuyavian-Pomeranian Voivodeship, Poland (Recruiting)
- Pratia MCM Krakow — Krakow, Malopolska, Poland (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Andalusia, Spain (Recruiting)
- Hospital Universitari Mutua Terrassa — Terrassa, Barcelona, Spain (Recruiting)
- Hospital Clinico Universitario Virgen De La Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Hospital de Cabuenes — Gijón, Principality of Asturias, Spain (Recruiting)
- Hospital Sant Pau — Barcelona, Spain (Recruiting)
- Universitaru Hospital La Princesa — Madrid, Spain (Recruiting)
- Hospital General Universitario Morales Meseguer — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.