Status:
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
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Smoldering Multiple Myeloma (SMM)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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 unexplained signs of infection, as described in the protocol
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 18 2032
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06140524
Start Date
September 16 2024
End Date
May 18 2032
Last Update
September 3 2025
Active Locations (12)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
4
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107