A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

NCT06140524 · tracked via the Priya Life Science France tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 2

Started

2024-09-16

Last updated

2026-07-08

Condition(s) studied

Monoclonal Gammopathy of Undetermined Significance (MGUS)Smoldering Multiple Myeloma (SMM)

Investigational drug(s) / intervention(s)

Linvoseltamab →

Linvoseltamab: Administered per the protocol

Study summary

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.

The study is looking at several other research questions, including:

* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?
* What side effects may happen from taking the study drug?
* How much study drug is in the blood at different times?
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Frequency of Adverse Events Interest (AEI) during the safety observation period — 35 days
Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period — 35 days
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Severity of TEAEs during the safety observation period — 35 days
Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
Achievement of Complete Response (CR) as determined by the investigator — Up to 5.5 years
Part 2

Trial sites (39)

Facility	City	Region	Status
Johns Hopkins Hospital	Baltimore	Maryland	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
University of Michigan Health	Ann Arbor	Michigan	Recruiting
NYU Langone Health Perlmutter Cancer Center	New York	New York	Recruiting
Stony Brook University Hospital	Stony Brook	New York	Recruiting
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	Recruiting
University of Washington	Seattle	Washington	Recruiting
Algemeen Ziekenhuis (AZ) Klina	Brasschaat	Antwerpen	Recruiting
AZ St.-Elisabeth Herentals vzw	Herentals	Antwerp	Recruiting
AZ Sint Maarten Algemeen Ziekenhuis Emmaus	Mechelen	Flanders	Recruiting
Algemeen Ziekenhuis St Jan Brugge Oostende Av	Bruges	West-Vlaanderen	Recruiting
Algemeen Ziekenhuis AZ Delta	Roeselare	West-Vlaanderen	Recruiting
Ziekenhuis Netwerk Antwerpen Cadix, Hematology	Antwerp	Belgium	Recruiting
Centre Hospitalier Universitaire De Poitiers	Poitiers	New Aquitaine	Recruiting
Institut Curie	Paris	Île-de-France Region	Recruiting
Galway University Hospital	Galway	Connacht	Recruiting
Cork University Hospital	Cork	Ireland	Recruiting
Mater Misericordiae University Hospital	Dublin	Ireland	Recruiting
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori	Meldola	Forli-Cesena	Recruiting
IRCCS Ospedale Policlinico San Martino	Genoa	Genova	Recruiting
San Paolo Hospital	Milan	Lombardy	Recruiting
Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont	Recruiting
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno	Ascoli Piceno	Italy	Recruiting
Universita degli Studi di Pavia - Fondazione IRCCS Policlini	Pavia	Italy	Recruiting
Ospedale Santa Maria delle Croci	Ravenna	Italy	Recruiting
Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital	Torun	Kuyavian-Pomeranian Voivodeship	Recruiting
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu	Wałbrzych	Lower Silesian Voivodeship	Recruiting
Pratia MCM Krakow	Krakow	Malopolska	Recruiting
University Clinical Center / Medical University of Gdansk	Gdansk	Pomeranian Voivodeship	Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)	Lodz	Poland	Recruiting
Swietokrzyskie Centrum Onkologii	Kielce	Świętokrzyskie Voivodeship	Recruiting
Hospital Universitario Virgen de las Nieves	Granada	Andalusia	Recruiting
Hospital Universitari Mutua Terrassa	Terrassa	Barcelona	Recruiting
Hospital Clinico Universitario Virgen De La Arrixaca	El Palmar	Murcia	Recruiting
Hospital de Cabuenes	Gijón	Principality of Asturias	Recruiting
Hospital Sant Pau	Barcelona	Spain	Recruiting
Institut Catala dOncologia (ICO Hospitalet)	Barcelona	Spain	Recruiting
Universitaru Hospital La Princesa	Madrid	Spain	Recruiting
Hospital General Universitario Morales Meseguer	Murcia	Spain	Recruiting

More Regeneron Pharmaceuticals trials in France

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma Recruiting

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Active, not recruiting

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma Active, not recruiting

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe Recruiting

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06140524 on ClinicalTrials.gov ↗ ← All trials in France