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

Launched by REGENERON PHARMACEUTICALS · Nov 17, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new medication called linvoseltamab to see if it can help eliminate abnormal plasma cells that could lead to conditions like Multiple Myeloma in adults who have either high-risk Monoclonal Gammopathy of Undetermined Significance (MGUS) or non-high-risk Smoldering Multiple Myeloma (SMM). The study aims to understand how safe the medication is and how effectively it works in reducing these abnormal cells. Participants will start with small doses of linvoseltamab, which will gradually increase, and the study is divided into two parts: the first part focuses on understanding the short-term side effects of different doses, while the second part involves more patients to further assess safety and effectiveness.

To be eligible for this trial, participants should be between 65 and 74 years old and have either HR-MGUS or NHR-SMM. They must also be in good overall health, with functioning kidneys and no recent serious infections. Throughout the study, participants can expect to receive careful monitoring for any side effects and regular assessments to see if their condition improves. This trial not only hopes to find out how well linvoseltamab works but also looks at how much of the drug remains in the bloodstream and whether the body creates any reactions against it.

Gender

ALL

Eligibility 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 m2 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 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
• • NOTE: Other protocol defined inclusion/exclusion criteria apply