Purpose of this Study
We are doing this study to evaluate the safety and effectiveness of a drug called isatuximab when it is used in
combination with lenalidomide and dexamethasone at lower doses. We want to know if this low dose combination can help patients with multiple myeloma achieve a better response while causing fewer or less severe side effects.
combination with lenalidomide and dexamethasone at lower doses. We want to know if this low dose combination can help patients with multiple myeloma achieve a better response while causing fewer or less severe side effects.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are newly diagnosed with multiple myeloma (NDMM); OR</li>
<li>Are toxicity-vulnerable patients diagnosed with multiple myeloma</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: quinna.marshburn@duke.edu">quinna.marshburn@duke.edu.</a>
<li>Are newly diagnosed with multiple myeloma (NDMM); OR</li>
<li>Are toxicity-vulnerable patients diagnosed with multiple myeloma</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: quinna.marshburn@duke.edu">quinna.marshburn@duke.edu.</a>
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 a bone survey (a series of x-rays of all the bones in the body)</li>
<li>Have blood draws and give urine samples</li>
<li>Have bone marrow samples taken</li>
<li>Have images taken (X-rays, CT, MRI, or PET-CT scans)</li>
<li>Have a tumor assessment</li></ul>
If you are eligible to continue after screening, you will begin the study drug period. Each drug cycle during this period is 28 days long.
<strong>Drug Cycle 1:</strong> You will get an isatuximab infusion once weekly on days 1, 8, 15, and 22 of this cycle.
Lenalidomide will be taken every day during this cycle for three weeks, followed by a one week
break (you will not take lenalidomide on the 4th week). You will take a dexamethasone pill on
days you are scheduled to receive an isatuximab infusion. You should take the dexamethasone pill
before the isatuximab infusion.
<strong>Cycles 2-8:</strong> You will get an isatuximab infusion once every other week, specifically on days 1
and 15 of each study drug cycle. Lenalidomide will be taken every day during each study drug
cycle for three weeks followed by a one week break. On days you are scheduled to receive
isatuximab infusion, you should take a dexamethasone pill before the infusion.
<strong>Cycles 9-17:</strong> you will receive isatuximab infusion once every other week, specifically on days 1
and 15 of each study drug cycle. Lenalidomide will be taken every day during each study drug
cycle for three weeks followed by a one week break. You will not take any dexamethasone
during these study drug cycles, unless the study doctor decides that you should continue taking it.
<strong>Cycles 18-24:</strong> you will receive isatuximab infusion once only on Day 1 of each study drug cycle.
Lenalidomide will be taken every day during each study drug cycle for three weeks followed by
a one week break. You will not take any dexamethasone during cycles 18-24, unless the study doctor decides that you should continue taking it.
After completing 24 study drug cycles, you will move into the maintenance period where you will take lenalidomide only. You will continue taking lenalidomide for as long as it benefits you.
<li>Have a physical exam</li>
<li>Have a bone survey (a series of x-rays of all the bones in the body)</li>
<li>Have blood draws and give urine samples</li>
<li>Have bone marrow samples taken</li>
<li>Have images taken (X-rays, CT, MRI, or PET-CT scans)</li>
<li>Have a tumor assessment</li></ul>
If you are eligible to continue after screening, you will begin the study drug period. Each drug cycle during this period is 28 days long.
<strong>Drug Cycle 1:</strong> You will get an isatuximab infusion once weekly on days 1, 8, 15, and 22 of this cycle.
Lenalidomide will be taken every day during this cycle for three weeks, followed by a one week
break (you will not take lenalidomide on the 4th week). You will take a dexamethasone pill on
days you are scheduled to receive an isatuximab infusion. You should take the dexamethasone pill
before the isatuximab infusion.
<strong>Cycles 2-8:</strong> You will get an isatuximab infusion once every other week, specifically on days 1
and 15 of each study drug cycle. Lenalidomide will be taken every day during each study drug
cycle for three weeks followed by a one week break. On days you are scheduled to receive
isatuximab infusion, you should take a dexamethasone pill before the infusion.
<strong>Cycles 9-17:</strong> you will receive isatuximab infusion once every other week, specifically on days 1
and 15 of each study drug cycle. Lenalidomide will be taken every day during each study drug
cycle for three weeks followed by a one week break. You will not take any dexamethasone
during these study drug cycles, unless the study doctor decides that you should continue taking it.
<strong>Cycles 18-24:</strong> you will receive isatuximab infusion once only on Day 1 of each study drug cycle.
Lenalidomide will be taken every day during each study drug cycle for three weeks followed by
a one week break. You will not take any dexamethasone during cycles 18-24, unless the study doctor decides that you should continue taking it.
After completing 24 study drug cycles, you will move into the maintenance period where you will take lenalidomide only. You will continue taking lenalidomide for as long as it benefits you.
Study Details
Full Title
LCCC 1944, A Phase 2 Study of Isatuximab Plus Lenalidomide and Dexamethasone in Highly Toxicity-Vulnerable Subjects with Newly Diagnosed Multiple Myeloma
Principal Investigator
Cristiana Costa
Chase
Protocol Number
PRO00110204
NCT ID
NCT05145400
Phase
II
Enrollment Status
Open to Enrollment