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

Overview

About this study

The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM).  Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status <= 1.

- Laboratory values meeting the criteria outlined in the protocol.

- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.

- Has measurable disease at screening as defined in the protocol.

- Locally documented or centrally determined t(11;14) positive status and/or centrally determined BCL2high status.

Note: If local testing for t(11;14) is discordant with central testing for t(11;14) status, a detailed review of central and local results for t(11;14) status is required to ensure the participants' safety.

- Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and received all standard of care (SOC) agents in previous line(s) of
therapy, including a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody.

- Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy.

- Life expectancy >= 12 weeks.

Exclusion Criteria:

- Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/12/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions