Linvoseltamab
DrugLinvoseltamab will be administered by intravenous (IV) infusion
Other names: REGN5458, Lynozyfic™
NCT Number: NCT05828511
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, Vienne, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Linvoseltamab will be administered by intravenous (IV) infusion
Other names: REGN5458, Lynozyfic™
Time frame: End of the Observation period; up to day 28
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Up to 5 years
Phase 2
Time frame: Up to 5 years
Phase 2 Transplant-eligible cohort
Time frame: Up to 5 years
Phase 2 Transplant-eligible cohort
Time frame: Up to 5 years
Phase 2 Transplant-ineligible cohort
Time frame: Up to 5 years
Phase 2 Transplant ineligible cohort
Time frame: Post-Last Linvoseltamab Dose, up to 12 weeks
Phases 1 and 2
Time frame: Post-Last Linvoseltamab Dose, up to 12 weeks
Phases 1 and 2
Time frame: Post-Last Linvoseltamab Dose, up to 30 days
Phases 1 and 2
Time frame: Post-Last Linvoseltamab Dose, up to 30 days
Phases 1 and 2
Time frame: Up to 5 years
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 1
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Up to 5 years
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Post-Last Linvoseltamab Dose, up to 90 days
Phase 2
Time frame: Up to 5 years
Phase 2
Time frame: At cycle 4 of induction (each cycle is 28 days long)
Phase 2 Transplant-eligible cohort
Time frame: Up to 100 days post-transplant
Phase 2 Transplant-eligible cohort
Time frame: Up to 100 days post-transplant
Phase 2 Transplant-eligible cohort
Time frame: Up to 5 years
Phase 2 Transplant-eligible cohort
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma
Acronym: LINKER-MM4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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