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)
NCT ID: NCT06953960
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2025-07-23
2030-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Substudy 1: Dose Expansion and Selection Control
Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.
Daratumumab
Subcutaneous (SC) Injection
Dexamethasone
Oral Tablet
Pomalidomide
Oral Capsule
Substudy 1: Dose Expansion and Selection ABBV-453 Combination
Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.
ABBV-453
Oral Tablet
Daratumumab
Subcutaneous (SC) Injection
Dexamethasone
Oral Tablet
Substudy 1: Dose Escalation ABBV-453 Combination
Participants 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.
ABBV-453
Oral Tablet
Daratumumab
Subcutaneous (SC) Injection
Dexamethasone
Oral Tablet
Substudy 2: Dose Escalation ABBV-453 Monotherapy
Japanese 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.
ABBV-453
Oral Tablet
Interventions
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ABBV-453
Oral Tablet
Daratumumab
Subcutaneous (SC) Injection
Dexamethasone
Oral Tablet
Pomalidomide
Oral Capsule
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Southern California /ID# 272414
Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, United States
University of North Carolina at Chapel Hill /ID# 272454
Chapel Hill, North Carolina, United States
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, United States
Liverpool Hospital /ID# 272002
Liverpool, New South Wales, Australia
Calvary Mater Newcastle /ID# 272498
Waratah, New South Wales, Australia
St Vincent's Hospital - Melbourne /ID# 271997
Fitzroy, Victoria, Australia
Epworth Hospital /ID# 272497
Richmond, Victoria, Australia
UZ Gent /ID# 271432
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 272382
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 271430
Liège, , Belgium
CHU de Montpellier - Hopital Saint Eloi /ID# 275570
Montpellier, Herault, France
The Chaim Sheba Medical Center /ID# 271251
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 271252
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 271256
Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 271253
Jerusalem, , Israel
Rabin Medical Center. /ID# 272073
Petah Tikva, , Israel
Nagoya City University Hospital /ID# 271427
Nagoya, Aichi-ken, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 271911
Kyoto, Kyoto, Japan
The University of Osaka Hospital /ID# 271636
Suita-shi, Osaka, Japan
Japanese Red Cross Medical Center /ID# 272018
Shibuya-ku, Tokyo, Japan
The Jikei University Hospital /ID# 272091
Tokyo, , Japan
Instituto Português de Oncologia de Lisboa Francisco Gentil /ID# 275873
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Braga, EPE /ID# 275853
Braga, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 275851
Porto, , Portugal
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-517140-65
Identifier Type: OTHER
Identifier Source: secondary_id
M25-275
Identifier Type: -
Identifier Source: org_study_id