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)
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma
2 other identifiers
interventional
130
8 countries
32
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 of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. Approximately 130 adult participants with R/R MM will be enrolled in the study in approximately 40 sites worldwide. In Substudy 1 escalation phase, participants will receive oral ABBV-453 tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral ABBV-453 tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral ABBV-453 tablets. The total study duration is approximately 4.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Jul 2025
Typical duration for phase_1 multiple-myeloma
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
February 23, 2026
February 1, 2026
5.4 years
April 17, 2025
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose-Limiting Toxicities (DLT)s of ABBV-453
DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.
Up to Approximately 45 Months
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 4.5 Years
Secondary Outcomes (7)
Overall Response Rate (ORR)
Up to Approximately 4.5 Years
Progression-Free Survival (PFS)
Up to Approximately 4.5 Years
Duration of Response (DOR)
Up to Approximately 4.5 Years
Time-to-Progression (TTP)
Up to Approximately 4.5 Years
Time to Next Treatment
Up to Approximately 4.5 Years
- +2 more secondary outcomes
Study Arms (4)
Substudy 1: Dose Escalation ABBV-453 Combination
EXPERIMENTALParticipants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.
Substudy 1: Dose Expansion and Selection ABBV-453 Combination
EXPERIMENTALParticipants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.
Substudy 1: Dose Expansion and Selection Control
ACTIVE COMPARATORParticipants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.
Substudy 2: Dose Escalation ABBV-453 Monotherapy
EXPERIMENTALJapanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.
Interventions
Oral Tablet
Subcutaneous (SC) Injection
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (32)
University of Southern California /ID# 272414
Los Angeles, California, 90033, United States
University of Michigan Health System - Ann Arbor /ID# 271536
Ann Arbor, Michigan, 48109, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, 10065, United States
University of North Carolina at Chapel Hill /ID# 272454
Chapel Hill, North Carolina, 27514, United States
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, 98405, United States
Liverpool Hospital /ID# 272002
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle /ID# 272498
Waratah, New South Wales, 2298, Australia
St Vincent's Hospital - Melbourne /ID# 271997
Fitzroy, Victoria, 3065, Australia
Epworth Hospital /ID# 272497
Richmond, Victoria, 3121, Australia
UZ Gent /ID# 271432
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 272382
Leuven, Vlaams-Brabant, 3000, Belgium
CHU de Liege /ID# 271430
Liège, 4000, Belgium
CHU de Montpellier - Hopital Saint Eloi /ID# 275570
Montpellier, Herault, 34295, France
Centre Hospitalier Universitaire de Poitiers /ID# 275563
Poitiers, Nouvelle-Aquitaine, 86021, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562
Nantes, Pays de la Loire Region, 44000, France
Hopital Universitaire Necker Enfants Malades /ID# 275571
Paris, Île-de-France Region, 75015, France
The Chaim Sheba Medical Center /ID# 271251
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 271252
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 271256
Haifa, 3525408, Israel
Hadassah Medical Center-Hebrew University /ID# 271253
Jerusalem, 91120, Israel
Rabin Medical Center. /ID# 272073
Petah Tikva, 4941492, Israel
Nagoya City University Hospital /ID# 271427
Nagoya, Aichi-ken, 467-8602, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 271911
Kyoto, Kyoto, 602-8566, Japan
The University of Osaka Hospital /ID# 271636
Suita-shi, Osaka, 565-0871, Japan
Japanese Red Cross Medical Center /ID# 272018
Shibuya-ku, Tokyo, 150-8935, Japan
The Jikei University Hospital /ID# 272091
Tokyo, 105-8461, Japan
Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873
Lisbon, Lisbon District, 1099-023, Portugal
Unidade Local de Saude de Braga, EPE /ID# 275853
Braga, 4710-243, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 275851
Porto, 4200-072, Portugal
Karolinska University Hospital Solna /ID# 271674
Solna, Stockholm County, 171 64, Sweden
Sodra Alvsborgs sjukhus /ID# 271822
Borås, Västra Götaland County, 501 82, Sweden
Sahlgrenska Universitetssjukhuset /ID# 272448
Gothenburg, Västra Götaland County, 413 46, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
May 1, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.