A Phase 1 Study of ABBV-453 in People with Recurrent or Persistent Multiple Myeloma

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Full Title

First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects with Relapsed or Refractory Multiple Myeloma

Purpose

The purpose of this study is to find the highest dose of the investigational drug ABBV-453 that can be given safely in people with multiple myeloma that has come back or continued to grow despite therapy and makes too much of a protein called BCL2. ABBV-453 works by blocking BCL2.

When people have cancer that makes too much BCL2 or has a genetic change called the t(11;14) genetic translocation, the BCL2 protein promotes the growth and spread of cancer cells. By blocking BCL2, ABBV-453 may cause cancer cells to die or may slow cancer growth. It is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have multiple myeloma that makes too much BCL2 or has the t(11;14) genetic translocation.
  • Patients’ cancers must continue to grow despite treatment that included all standard therapies for multiple myeloma.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Saad Usmani at 646-608-4165.

Protocol

22-431

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05308654