A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Linvoseltamab: Linvoseltamab will be administered by intravenous (IV) infusion

Study summary

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).

The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.

This study consists of 2 phases:

* In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.
* In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
* In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.

The study is looking at several research questions, including:

* What side effects may happen from taking linvoseltamab?
* What the right dosing regimen is for linvoseltamab?
* How many participants treated with linvoseltamab have improvement of their disease and for how long?
* The effects of linvoseltamab study treatment before and after transplant
* How much linvoseltamab is in the blood at different times?
* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).

Eligibility

Primary outcome measure(s)

• Incidence of Dose-Limiting Toxicities (DLTs) — End of the Observation period; up to day 28
  Phase 1
• Incidence of Treatment-Emergent Adverse Events (TEAEs) — Post-Last Linvoseltamab Dose, up to 90 days
  Phase 1
• Severity of TEAEs — Post-Last Linvoseltamab Dose, up to 90 days
  Phase 1
• Incidence of Adverse Events of Special Interest (AESIs) — Post-Last Linvoseltamab Dose, up to 90 days
  Phase 1
• Severity of AESIs — Post-Last Linvoseltamab Dose, up to 90 days
  Phase 1
• Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria — Up to 5 years
  Phase 2
• Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy — Up to 5 years
  Phase 2 Transplant-eligible cohort
• Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy — Up to 5 years
  Phase 2 Transplant-eligible cohort
• Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II — Up to 5 years
  Phase 2 Transplant-ineligible cohort
• Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II — Up to 5 years
  Phase 2 Transplant ineligible cohort

Trial sites (32)

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