Study on Linvoseltamab and Lenalidomide for Deepening Responses in Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• Have a diagnosis of newly diagnosed multiple myeloma (NDMM) confirmed before any treatment.
• Have received an initial combination therapy with at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-CD38.
• Have received induction therapy with or without high-dose melphalan and autologous stem cell transplant, and are currently on lenalidomide maintenance therapy for 12 months or less.
  • Cohort 1: Currently have a partial response, very good partial response, or complete response but still have minimal residual disease (MRD+) as shown by a specific test.
  • Cohort 2: Have had a relapse from an initial complete response but do not meet criteria for disease progression.
• Have a performance status score of 3 or less, indicating the ability to carry out daily activities.
• Have adequate organ function, including specific blood counts and liver and kidney function.
• Female patients of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 90 days after the last dose.
• Willing and able to provide written informed consent and comply with study visits and procedures.

Exclusion Criteria

• Have received other treatments for multiple myeloma besides the initial combination therapy.
• Are currently receiving other investigational drugs unless approved by the study investigator.
• Have received a live vaccine within four weeks of starting the study treatment.
• Have allergies or contraindications to any medications used in the study.
• Have certain infections like HIV, hepatitis B, or active hepatitis C.
• Have a history of severe allergic reactions to similar drugs used in the study.
• Are pregnant, breastfeeding, or planning to father a child during the study or within three months after the last dose.
• Have certain heart conditions or uncontrolled illnesses that could interfere with the study.
• Have a history of neurodegenerative conditions or seizures unless deemed not significant by the investigator.
• Have another active cancer requiring treatment in the past six months.
• Have any condition that could compromise the study or the patient's well-being, as determined by the investigator.
• Have impaired decision-making capacity.