A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Launched by REGENERON PHARMACEUTICALS · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called linvoseltamab for people with high-risk smoldering multiple myeloma (SMM), which is a condition where a person has abnormal plasma cells in their blood but does not yet have full-blown multiple myeloma (MM). The main goals of the study are to see how safe the drug is and how well it can help reduce these abnormal cells, potentially preventing the progression to MM. The trial has two parts: the first part will involve a small group of participants to check for any early side effects of the drug, while the second part will include more participants to further evaluate its safety and effectiveness.

To be eligible for this trial, participants must have been diagnosed with high-risk SMM in the last five years, have a good level of physical functioning, and meet certain health criteria. Throughout the study, participants will receive linvoseltamab and will be monitored for any side effects and how well the drug is working. It’s important to know that not everyone with SMM will qualify, as there are specific health conditions that could exclude someone from participating. This trial is currently recruiting participants, and it aims to gather valuable information that could help improve treatment options for those at risk of developing multiple myeloma.

Gender

ALL

Eligibility criteria

• KEY Inclusion Criteria:
• • 1. High-risk SMM diagnosis within 5 years of study enrollment
• • 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 ≥30 mL/min/1.73 m\^2
• KEY Exclusion Criteria:
• • 1. Evidence of myeloma defining events \*SLiM CRAB, as described in the protocol
• • \*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light chain (FLC) being ≥100 mg/L, MRI with \>1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions)
• • 2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma
• • 3. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
• • 4. Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug
• • 5. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection
• • 6. History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient
• • NOTE: Other protocol defined inclusion/exclusion criteria apply