Purpose of this Study
We are doing this study to find out if an experimental drug called CC-92480 (the study drug) is a safe and effective treatment for multiple myeloma. We also want to figure out the most appropriate dose and schedule for giving the study drug to multiple myeloma patients.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have multiple myeloma that is not responding to therapy; OR</li>
<li>Have multiple myeloma that has come back after previous therapy</li></ul>
For more information about who can join this study, please contact the study team 919-668-0613.
<li>Have multiple myeloma that is not responding to therapy; OR</li>
<li>Have multiple myeloma that has come back after previous therapy</li></ul>
For more information about who can join this study, please contact the study team 919-668-0613.
What is Involved?
This study has three periods: a screening period, the study drug period, and a follow-up period.
If you choose to join this study, during the screening period you will:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging tests (X-Ray, MRI/CT/PET scans)</li>
<li>Have a bone marrow biopsy</li></ul>
If you are eligible to join the study, you will take the study drug as directed by the study doctor. You will continue taking the study drug for as long as you and the study doctor believe that you are benefitting from it.
After you stop taking the study drug, we will keep in touch with you to see how you are doing.
If you choose to join this study, during the screening period you will:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging tests (X-Ray, MRI/CT/PET scans)</li>
<li>Have a bone marrow biopsy</li></ul>
If you are eligible to join the study, you will take the study drug as directed by the study doctor. You will continue taking the study drug for as long as you and the study doctor believe that you are benefitting from it.
After you stop taking the study drug, we will keep in touch with you to see how you are doing.
Study Details
Full Title
Celgene: CA057-001 - A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY COMPARING CC-92480, BORTEZOMIB AND DEXAMETHASONE (480Vd) VERSUS POMALIDOMIDE, BORTEZOMIB AND DEXAMETHASONE (PVd) IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM)
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00112328
NCT ID
NCT05519085
Phase
III
Enrollment Status
Open to Enrollment