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

Condition(s) studied

Investigational drug(s) / intervention(s)

Linvoseltamab: Administered per the protocol

Study 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).

Eligibility

Primary outcome measure(s)

• Frequency of Adverse Events Interest (AEI) during the safety observation period — 35 days
  Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
• Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period — 35 days
  Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
• Severity of TEAEs during the safety observation period — 35 days
  Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)
• Achievement of Complete Response (CR) as determined by the investigator — Up to 5.5 years
  Part 2

Trial sites (39)