Purpose of this Study
We are doing this study to find out if an experimental drug called ABBV-453 (the study drug) is a safe and effective treatment for multiple myeloma. We want to identify the most appropriate dose and schedule to give patients the study drug.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have multiple myeloma that is not responding to therapy; OR
- Have multiple myeloma that has come back after previous therapy
For more information about who can join this study, please contact the study team 919-668-0613.
- Have multiple myeloma that is not responding to therapy; OR
- Have multiple myeloma that has come back after previous therapy
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:
- Have a physical exam
- Have blood draws
- Give urine samples
- Have imaging tests (X-Ray, MRI/CT/PET scans)
- Have a bone marrow biopsy
You will proceed to the study drug period if you are eligible after screening.
Only patients who are confirmed to carry the t(11;14) genetic translocation and/or display BCL2 high gene expression will be eligible for the study drug period.
During the study drug period, you will take the study drug in tablet form by mouth once daily during 28-day cycles. The number of study drug tablets you take daily will depend on your assigned dose level and the cohort you are assigned to in the study. Participants will be enrolled into a single cohort with a designated target dose level. You will not get to choose which cohort you will participate in. Your study doctor will inform you of the cohort in which you will participate.
When the study drug period ends, you will come back to our clinic a few more times for check-ups.
If you choose to join this study, during the screening period you will:
- Have a physical exam
- Have blood draws
- Give urine samples
- Have imaging tests (X-Ray, MRI/CT/PET scans)
- Have a bone marrow biopsy
You will proceed to the study drug period if you are eligible after screening.
Only patients who are confirmed to carry the t(11;14) genetic translocation and/or display BCL2 high gene expression will be eligible for the study drug period.
During the study drug period, you will take the study drug in tablet form by mouth once daily during 28-day cycles. The number of study drug tablets you take daily will depend on your assigned dose level and the cohort you are assigned to in the study. Participants will be enrolled into a single cohort with a designated target dose level. You will not get to choose which cohort you will participate in. Your study doctor will inform you of the cohort in which you will participate.
When the study drug period ends, you will come back to our clinic a few more times for check-ups.
Study Details
Full Title
First-in-Human Two-Part Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects with Relapsed or Refractory Multiple Myeloma
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00110431
NCT ID
NCT05308654
Phase
I
Enrollment Status
OPEN TO ACCRUAL