NCT05308654: Phase 1: A Study to Assess activity & AEs in RRMM Receiving Oral ABBV-453 Tablets

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

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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

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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

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Drug: ABBV-453

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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