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:<ul>
<li>Are diagnosed with multiple myeloma</li>
<li>Have received at least one previous round of treatment that included lenalidomide and a proteasome inhibitor without having a satisfactory response</li>
<li>Have not received more than 4 rounds of previous treatment</li>
<li>Have never taken elotuzumab or pomalidomide</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: heather.griffith@duke.edu">heather.griffith@duke.edu</a> or 919-668-1026.
<li>Are diagnosed with multiple myeloma</li>
<li>Have received at least one previous round of treatment that included lenalidomide and a proteasome inhibitor without having a satisfactory response</li>
<li>Have not received more than 4 rounds of previous treatment</li>
<li>Have never taken elotuzumab or pomalidomide</li>
<li>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</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: heather.griffith@duke.edu">heather.griffith@duke.edu</a> or 919-668-1026.
What is Involved?
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:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to either take the study drug or take the elotuzumab, pomalidomide, and dexamethasone combination therapy.
If you are assigned to take the study drug, you will receive infusions weekly for 3 cycles (4 weeks in each cycle), followed by infusions every 2 weeks (twice per cycle) starting at cycle 4. If you have a very good response to the study drug through cycle 6 (24 weeks), you will then get the study drug once per cycle (every 4 weeks). If you are getting a positive benefit but do not show a very good response according to the study doctor, you will continue to get the study drug every 2 weeks after cycle 6 until you show a very good response.
If you are assigned to get the combination therapy, you will get elotuzumab weekly for the first 2 cycles (4 weeks in each cycle) and then once per cycle starting with cycle 3. You will take pomalidomide for the first 21 days of each cycle, and you will get dexamethasone once per week for each cycle. This study regimen will last for as long as the study doctor thinks you are benefitting.
At various visits you will complete physical exams, neurological exams, questionnaires, vital signs, scans, heart imaging, biopsy and bone marrow aspirates, urine samples, and have blood tests.
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to either take the study drug or take the elotuzumab, pomalidomide, and dexamethasone combination therapy.
If you are assigned to take the study drug, you will receive infusions weekly for 3 cycles (4 weeks in each cycle), followed by infusions every 2 weeks (twice per cycle) starting at cycle 4. If you have a very good response to the study drug through cycle 6 (24 weeks), you will then get the study drug once per cycle (every 4 weeks). If you are getting a positive benefit but do not show a very good response according to the study doctor, you will continue to get the study drug every 2 weeks after cycle 6 until you show a very good response.
If you are assigned to get the combination therapy, you will get elotuzumab weekly for the first 2 cycles (4 weeks in each cycle) and then once per cycle starting with cycle 3. You will take pomalidomide for the first 21 days of each cycle, and you will get dexamethasone once per week for each cycle. This study regimen will last for as long as the study doctor thinks you are benefitting.
At various visits you will complete physical exams, neurological exams, questionnaires, vital signs, scans, heart imaging, biopsy and bone marrow aspirates, urine samples, and have blood tests.
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