Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called linvoseltamab (the study drug) compared to a combination of three cancer drugs(elotuzumab, pomalidomide, and dexamethasone) for people who have multiple myeloma.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with multiple myeloma
- Have received at least one previous round of treatment that included lenalidomide and a proteasome inhibitor without having a satisfactory response
- Have not received more than 4 rounds of previous treatment
- Have never taken elotuzumab or pomalidomide
- Have not received an allogeneic (donor) stem cell transplant in the past 6 months or an autologous (your own cells) stem cell transplant in the past 12 weeks
What is Involved?
Description
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have blood draws
- Have a tumor biopsy
Study Details
Full Title
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458;
anti-BCMA x anti-CD3 Bispecific Antibody) Versus the Combination of
Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients with
Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
anti-BCMA x anti-CD3 Bispecific Antibody) Versus the Combination of
Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients with
Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
Principal Investigator
Yubin
Kang
Protocol Number
PRO00114573
NCT ID
NCT05730036
Phase
III
Enrollment Status
Open to Enrollment