ABBV-453 for Relapsed or Refractory Multiple Myeloma

What is the 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.

What is the Condition Being Studied?

Relapsed or Refractory Multiple Myeloma

Who Can Participate in the Study?

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.

Age Group

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 the cohort in which you participate. 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
Professor of Medicine
Protocol Number
IRB: PRO00110431
NCT: NCT05308654
Phase I
Enrollment Status