Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06953960
Start Date
July 23 2025
End Date
December 1 2030
Last Update
January 6 2026
Active Locations (25)
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1
University of Southern California /ID# 272414
Los Angeles, California, United States, 90033
2
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, United States, 10065
3
University of North Carolina at Chapel Hill /ID# 272454
Chapel Hill, North Carolina, United States, 27514
4
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, United States, 98405