NCT05308654: Phase 1: A Study to Assess activity & AEs in RRMM Receiving Oral ABBV-453 Tablets
Updated: Feb 5
NCT05308654: Phase 1: A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants with Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. This study will include a dose escalation phase to determine the best dose of ABBV-453. Approximately 21 adult participants with R/R MM will be enrolled in the study in approximately 12 sites worldwide.
Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Sponsor
AbbVie
ClinicalTrials.gov Identifier: NCT05308654
Official Title: First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma
First Posted : April 4, 2022
Click here to see details on ClinicalTrials.gov
Drug: ABBV-453
Locations
United States, California
United States, Florida
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, New York
United States, North Carolina
United States, Tennessee