Oral ABBV-453 alone or with daratumumab and other myeloma medicines for adults with multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional study includes two substudies: one combining ABBV-453 with daratumumab and dexamethasone (with pomalidomide allowed in expansion) and one testing ABBV-453 alone. It begins with dose-escalation cohorts to identify tolerable dose levels and then proceeds to dose-expansion cohorts to further characterize safety and effects on disease activity. The trial enrolls adults with measurable relapsed/refractory multiple myeloma, enriched for t(11;14)-positive or BCL2-high disease. Adverse events and changes in standard myeloma activity measures are collected to inform future development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
* All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:

  * Serum M-protein \>= 0.5 g/dL (\>= 5g/L); OR
  * Urine M-protein \>= 200 mg/24 hours; OR
  * For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) \>= 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
* B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
* t(11;14) positive status and/or BCL2 high status.
* Must have confirmed diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria.

Exclusion Criteria:

* Major surgery within 4 weeks of study treatment or planned during study participation.
* Recent infection requiring systemic treatment that was completed \<= 14 days before first dose of study treatment and/or uncontrolled active systemic infection.

Where it's running

• University of Southern California /ID# 272414
  Los Angeles, California, United States Recruiting
• Yale University School of Medicine /ID# 272447
  New Haven, Connecticut, United States Recruiting
• Dana-Farber Cancer Institute /ID# 271846
  Boston, Massachusetts, United States Recruiting
• University of Michigan Health System - Ann Arbor /ID# 271536
  Ann Arbor, Michigan, United States Recruiting
• Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
  New York, New York, United States Recruiting
• Atrium Health Levine Cancer Institute /ID# 271510
  Charlotte, North Carolina, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.