Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 toxicity of ABBV-453 in adul...
Eligibility Criteria
Inclusion
- 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.
- Part 1 and Part 2, Arm 1 Only: Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and are triple class exposed to a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody in previous line(s) of therapy.
- Part 2, Arms 2 and 3 Only: Received 1 to 3 prior lines of therapy, including a PI or an IMiD.
- Part 1 only: Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy.
- Life expectancy \>= 12 weeks.
Exclusion
- Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol.
- Part 2 only: Previous treatment with venetoclax or BCL-2 inhibitor.
- Part 2, Arms 2 and 3 only: Prior daratumumab or other anti-CD38 therapy exposure that meets any of the criteria outlined in the protocol.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05308654
Start Date
May 17 2022
End Date
December 1 2025
Last Update
August 14 2025
Active Locations (21)
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1
Stanford University School of Med /ID# 242809
Stanford, California, United States, 94305-2200
2
Sylvester Comprehensive Cancer Center /ID# 243417
Miami, Florida, United States, 33136-1002
3
Tulane University School of Medicine /ID# 244854
New Orleans, Louisiana, United States, 70112
4
American Oncology Partners of Maryland /ID# 244858
Bethesda, Maryland, United States, 20817