A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That … (NCT06140524) | Clinical Trial Compass
RecruitingPhase 2
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
United States116 participantsStarted 2024-09-16
Plain-language 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 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Frequency of Adverse Events Interest (AEI) during the safety observation period
Timeframe: 35 days
2
Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period
Timeframe: 35 days
3
Severity of TEAEs during the safety observation period
Timeframe: 35 days
4
Achievement of Complete Response (CR) as determined by the investigator
✕. 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