Actively 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)
Led by AbbVie · Updated on 2026-02-23
130
Participants Needed
32
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
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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.
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B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
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t(11;14) positive status and/or BCL2 high status.
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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.
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Substudy 1 Dose Expansion Cohorts:
- Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 32 locations
1
University of Southern California /ID# 272414
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of Michigan Health System - Ann Arbor /ID# 271536
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, United States, 10065
Actively Recruiting
4
University of North Carolina at Chapel Hill /ID# 272454
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
5
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, United States, 98405
Actively Recruiting
6
Liverpool Hospital /ID# 272002
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
7
Calvary Mater Newcastle /ID# 272498
Waratah, New South Wales, Australia, 2298
Actively Recruiting
8
St Vincent's Hospital - Melbourne /ID# 271997
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
9
Epworth Hospital /ID# 272497
Richmond, Victoria, Australia, 3121
Actively Recruiting
10
UZ Gent /ID# 271432
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
11
Universitair Ziekenhuis Leuven /ID# 272382
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
12
CHU de Liege /ID# 271430
Liège, Belgium, 4000
Actively Recruiting
13
CHU de Montpellier - Hopital Saint Eloi /ID# 275570
Montpellier, Herault, France, 34295
Actively Recruiting
14
Centre Hospitalier Universitaire de Poitiers /ID# 275563
Poitiers, New Aquitaine, France, 86021
Actively Recruiting
15
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
16
Hopital Universitaire Necker Enfants Malades /ID# 275571
Paris, Île-de-France Region, France, 75015
Actively Recruiting
17
The Chaim Sheba Medical Center /ID# 271251
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
18
Tel Aviv Sourasky Medical Center /ID# 271252
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
19
Rambam Health Care Campus- Haifa /ID# 271256
Haifa, Israel, 3525408
Actively Recruiting
20
Hadassah Medical Center-Hebrew University /ID# 271253
Jerusalem, Israel, 91120
Actively Recruiting
21
Rabin Medical Center. /ID# 272073
Petah Tikva, Israel, 4941492
Actively Recruiting
22
Nagoya City University Hospital /ID# 271427
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
23
University Hospital Kyoto Prefectural University of Medicine /ID# 271911
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
24
The University of Osaka Hospital /ID# 271636
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
25
Japanese Red Cross Medical Center /ID# 272018
Shibuya-ku, Tokyo, Japan, 150-8935
Actively Recruiting
26
The Jikei University Hospital /ID# 272091
Tokyo, Japan, 105-8461
Actively Recruiting
27
Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873
Lisbon, Lisbon District, Portugal, 1099-023
Actively Recruiting
28
Unidade Local de Saude de Braga, EPE /ID# 275853
Braga, Portugal, 4710-243
Actively Recruiting
29
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 275851
Porto, Portugal, 4200-072
Actively Recruiting
30
Karolinska University Hospital Solna /ID# 271674
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
31
Sodra Alvsborgs sjukhus /ID# 271822
Borås, Västra Götaland County, Sweden, 501 82
Actively Recruiting
32
Sahlgrenska Universitetssjukhuset /ID# 272448
Gothenburg, Västra Götaland County, Sweden, 413 46
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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