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

The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM.

SparkCures ID 1254
Trial Phase Phase 1
Enrollment 34 Patients
Treatments
  • ABBV-453
Tags
Trial Sponsors
  • AbbVie
NCT Identifier

NCT05308654

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.
  • Known or centrally determined t(11;14) positive status and/or centrally determined BCL2high status.
  • 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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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