A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)

Launched by ABBVIE · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ABBV-453 for adults with multiple myeloma (MM), a type of cancer affecting the bone marrow. The trial aims to find out how safe ABBV-453 is and how it affects the disease when taken alone or in combination with other treatments, like daratumumab and dexamethasone. The study will involve around 130 participants from various locations worldwide, and it will be conducted in two parts. In the first part, researchers will test different doses of ABBV-453 combined with other drugs to find the best dose. The second part will focus on the effects of ABBV-453 on its own.

To be eligible for this trial, participants must have a confirmed diagnosis of multiple myeloma and have measurable disease markers. They should also have previously received certain treatments for their cancer. It's important for potential participants to know that they will have to attend regular visits for check-ups, including blood tests, to monitor their health and any side effects. While the trial might involve more visits and treatments than standard care, it offers a chance to contribute to important research that could help improve treatments for multiple myeloma.

Gender

ALL

Eligibility criteria

• 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.
• * Substudy 1 Dose Escalation Cohorts and Substudy 2:
• • -- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator.
• * Substudy 1 Dose Expansion Cohorts:
• • Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.
• Exclusion Criteria:
• • Major surgery within 4 weeks of study treatment or planned during study participation.
• • Active infections: no recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or uncontrolled systemic infection.
• • Recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.