Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-04-08
116
Participants Needed
20
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) or Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM) as defined by the study protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Adequate blood and liver function as described in the protocol
- Estimated glomerular filtration rate (GFR) of 30 mL/min/1.73 m² or higher calculated by the MDRD equation
You will not qualify if you...
- Diagnosis of high-risk smoldering multiple myeloma as defined in the protocol
- Evidence of myeloma-defining events as described in the protocol
- Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia, solitary plasmacytoma, or symptomatic multiple myeloma
- Clinically significant heart or blood vessel disease within 3 months before enrollment
- Infection requiring hospitalization or intravenous anti-infective treatment within 28 days prior to first study drug dose
- Uncontrolled HIV, hepatitis B or C infection, or other uncontrolled or unexplained infections as described in the protocol
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Michigan Health
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
5
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
7
Algemeen Ziekenhuis (AZ) Klina
Brasschaat, Antwerpen, Belgium, 2930
Actively Recruiting
8
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
9
Cork University Hospital
Cork, Ireland, T12 EC8P
Actively Recruiting
10
Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
11
San Paolo Hospital
Milan, Lombardy, Italy, 20142
Actively Recruiting
12
Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
13
Pratia MCM Krakow
Krakow, Malopolska, Poland, 30-510
Actively Recruiting
14
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain, 18014
Actively Recruiting
15
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
Actively Recruiting
16
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
17
Hospital de Cabuenes
Gijón, Principality of Asturias, Spain, 33203
Actively Recruiting
18
Hospital Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
19
Universitaru Hospital La Princesa
Madrid, Spain, 28006
Actively Recruiting
20
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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