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New treatment option for Monoclonal Gammopathy of Undetermined Significance (MGUS)
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
ClinicalTrials.gov ID: NCT06140524
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, being studied as a potential treatment for monoclonal gammopathy of undetermined significance (mgus).
Also referred to as REGN5458, Lynozyfic™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- HR-MGUS or NHR-SMM as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate hematologic and hepatic function, as described in the protocol
- Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation Key
You likely can't join if
- High-risk SMM, as defined in the protocol
- Evidence of any of myeloma-defining events, as described in the protocol
- Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM
- Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
- Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab
- Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Brasschaat, Antwerpen, Belgium
- Herentals, Antwerp, Belgium
- Mechelen, Flanders, Belgium
- Bruges, West-Vlaanderen, Belgium
- Roeselare, West-Vlaanderen, Belgium
- Antwerp, Belgium
- Poitiers, New Aquitaine, France
- Paris, Île-de-France Region, France
- Galway, Connacht, Ireland
- Cork, Ireland
- Dublin, Ireland
- Meldola, Forli-Cesena, Italy
- Genoa, Genova, Italy
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Stony Brook, New York, United States; Philadelphia, Pennsylvania, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.