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)

Start 23 Oct 2025 · Status Ongoing, recruiting · 7 EU/EEA countries · 27 sites · Protocol M25-275

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruiting

Participants planned 119

Countries 7

Sites 27

Multiple Myeloma (MM).

To characterize the safety and tolerability of ABBV-453 monotherapy and/ or in combination with antimyeloma agents in participants with multiple myeloma (MM).

Key facts

Sponsor: AbbVie Deutschland GmbH & Co. KG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 23 Oct 2025 → ongoing
Decision date (initial): 2025-10-06
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: AbbVie Inc

External identifiers

EU CT number: 2024-517140-65-00
ClinicalTrials.gov: NCT06953960

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To characterize the safety and tolerability of ABBV-453 monotherapy and/ or in combination with antimyeloma agents in participants with multiple myeloma (MM).

Secondary objectives 2

To evaluate the preliminary antimyeloma activity of ABBV-453 monotherapy and/or in combination with antimyeloma agents in participants with MM.
To characterize the pharmacokinetic (PK) profile of ABBV-453 when given alone and/or in combination with antimyeloma agents in participants with MM.

Conditions and MedDRA coding

Multiple Myeloma (MM).

Version	Level	Code	Term	System organ class
21.0	LLT	10028228	Multiple myeloma	10029104

Regulatory references

Scientific advice from competent authorities: Food And Drug Administration, European Medicines Agency, Pharmaceuticals And Medical Devices Agency
Plan to share IPD: Yes
IPD plan description: 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.   To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/   For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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.

Exclusion criteria 2

Major surgery within 4 weeks of study treatment or planned during study participation.
Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

Dose Limiting Toxicities (DLT)s of ABBV-453
Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).

Secondary endpoints 8

Overall Response Rate (ORR)
Progression-Free Survival (PFS)
Duration of Response (DOR)
Time-to-Progression (TTP)
Time to Next Treatment
Rate and Depth of minimal residual disease (MRD) Negativity Determined Centrally
Overall survival (OS)
Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 9

Daratumumab

SUB175772 · Substance

Active substance: Daratumumab
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pomalidomide

SUB33379 · Substance

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pomalidomide

SUB33379 · Substance

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pomalidomide

SUB33379 · Substance

Active substance: Pomalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Surzetoclax

PRD10148579 · Product

Active substance: Surzetoclax
Substance synonyms: ABBV-453, 4-[(4aS,10aR)-14-(4-Chlorophenyl)-12,12-dimethyl-1,2,4a,5,8,9,11,12,13,15-decahydro7H,10aH-pyrazino[2,1-g][1,5,8]benzodioxazacycloundecin-3(4H)-yl]-2-(3,4-dihydro-2H-pyrrolo[3',2':5,6]pyrido[2,3-b][1,4]oxazepin-1(7H)-yl)-N-[4-({[(2S,5R)-5-methoxyoxan-2-yl]methyl}amino)-3-nitrobenzene-1-sulfonyl]benzamide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation: No
Orphan designation: No

Surzetoclax

PRD10148578 · Product

Active substance: Surzetoclax
Substance synonyms: ABBV-453, 4-[(4aS,10aR)-14-(4-Chlorophenyl)-12,12-dimethyl-1,2,4a,5,8,9,11,12,13,15-decahydro7H,10aH-pyrazino[2,1-g][1,5,8]benzodioxazacycloundecin-3(4H)-yl]-2-(3,4-dihydro-2H-pyrrolo[3',2':5,6]pyrido[2,3-b][1,4]oxazepin-1(7H)-yl)-N-[4-({[(2S,5R)-5-methoxyoxan-2-yl]methyl}amino)-3-nitrobenzene-1-sulfonyl]benzamide
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation: AbbVie Deutschland GmbH & Co. KG
Address: Knollstrasse
City: Ludwigshafen Am Rhein
Postcode: 67061
Country: Germany

Scientific contact point

Organisation: AbbVie Deutschland GmbH & Co. KG
Contact name: Global Clinical Trials Helpdesk

Public contact point

Organisation: AbbVie Deutschland GmbH & Co. KG
Contact name: Global Clinical Trials Helpdesk

Third parties 7

Organisation	City, country	Duties
Abbott Molecular Inc. ORG-100047852	Des Plaines, United States	Laboratory analysis
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	Data management, E-data capture
Labcorp Central Laboratory Services Sàrl ORL-000005229	Geneva, Switzerland	Laboratory analysis
Qiagen Manchester Limited ORG-100050466	Manchester, United Kingdom	Laboratory analysis
Advarra Inc. ORG-100045827	Columbia, United States	Other
Clario (formerly ERT) ORL-000007811	Philadelphia, United States	Other
Iqvia Biotech LLC ORG-100008704	Durham, United States	Laboratory analysis

Locations

7 EU/EEA countries · 27 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	9	3
France	Ongoing, recruiting	12	5
Germany	Ongoing, recruiting	16	4
Italy	Authorised, recruiting	12	5
Poland	Ongoing, recruiting	13	4
Portugal	Authorised, recruiting	7	3
Sweden	Ongoing, recruiting	7	3
Rest of world United States, United Kingdom, Australia, Israel	—	43	—

Investigational sites

Belgium

3 sites · Ongoing, recruiting

UZ Leuven

Hematology, Herestraat 49, 3000, Leuven

Centre hospitalier universitaire de Liege

Hematology, Avenue De L'Hopital 1, 4000, Liege

Universitair Ziekenhuis Gent

Hematology, Corneel Heymanslaan 10, 9000, Gent

France

5 sites · Ongoing, recruiting

Centre Hospitalier Universitaire De Poitiers

Oncology Hematology, 2 Rue De La Miletrie, 86000, Poitiers

Assistance Publique Hopitaux De Paris

Adult Hematology Department, 149 Rue De Sevres, 75015, Paris

Oncopole Claudius Regaud

Medical Oncology - Early Phase Unit, 1 Avenue Irene Joliot Curie, 31100, Toulouse

Centre Hospitalier Universitaire De Nantes

Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes

Centre Hospitalier Universitaire De Montpellier

Clinical Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Germany

4 sites · Ongoing, recruiting

LMU Klinikum Muenchen AöR

Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich

Universitaetsklinikum Wuerzburg AöR

Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg

Universitaetsklinikum Heidelberg AöR

Medizinische Klinik V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg

University Medical Center Hamburg-Eppendorf

II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg

Italy

5 sites · Authorised, recruiting

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

HEMATOLOGY UNIT, Via Piero Maroncelli 40, 47014, Meldola

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Hematology U Division, Corso Bramante 88, 10126, Turin

IRCCS Istituto Nazionale Tumori Fondazione Pascale

SC Ematologia Oncologica e Trapianto di Cellule Staminali, Via Mariano Semmola 52, 80131, Naples

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

S.C. Ematologia, Via Francesco Sforza 35, 20122, Milan

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Hematology and Bone Marrow Unit, Piazza Oms 1, 24127, Bergamo

Poland

4 sites · Ongoing, recruiting

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Oddzial Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Klinika Nowotworow Układu Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Uniwersytecki Szpital Kliniczny W Poznaniu

Oddzial Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Klinika Hematoonkologii i Transplantacji Szpiku Oddział Hematoonkologii i Transplantacji Szpiku i Ch, Ul. Stanislawa Staszica 11, 20-081, Lublin

Portugal

3 sites · Authorised, recruiting

CCAB Centro Clinico Academico Braga Associacao

Oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga

Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.

Oncology, Rua Professor Lima Basto, 1099-023, Lisbon

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Sweden

3 sites · Ongoing, recruiting

Soedra Aelvsborg Hospital Vaestra Goetalandsregionen

Medicinkliniken, Hiss E plan 7, Bramhultsvagen 53, Boras Gustav Adolf, Boras

Karolinska University Hospital

Cancerstudieenheten M62, Halsovagen, Flemingsberg, Huddinge

Sahlgrenska University Hospital-Vaestra Goetalandsregionen

Department of Hematology, Bla Straket 5, Goteborgs Annedal, Goteborg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Belgium	2025-10-23	2026-01-06
France	2025-12-23	2026-03-11
Germany	2026-04-16	2026-05-06
Italy	2026-04-28
Poland	2026-02-27	2026-05-26
Portugal	2025-11-25
Sweden	2026-01-26	2026-02-17

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_m25275-master-protocol-redacted	2.2 EU
Protocol (for publication)	D1_m25275-substudy-1-redacted	2.2 EU
Recruitment arrangements (for publication)	K1 M25-275 FR Recruitment and ICF Procedures_Public	1.1
Recruitment arrangements (for publication)	K1 M25-275 PT Recruitment and ICF Procedures_Public	2.0
Recruitment arrangements (for publication)	K1 M25-275 SE Recruitment and ICF Procedures	1
Recruitment arrangements (for publication)	K1_M25-275 BE Recruitment and ICF Procedures_Public	2.0
Recruitment arrangements (for publication)	K1_M25-275 EU CTR Recruitment and ICF Procedures - Study_Public	1.2
Recruitment arrangements (for publication)	K1_M25-275 PL Recruitment and ICF Procedures_Public	2
Recruitment arrangements (for publication)	K1_M25-275_DE_Recruitment and ICF Procedures_Public	1.0 DE
Subject information and informed consent form (for publication)	L1 M25-275 FR ICF Addendum_Public	1
Subject information and informed consent form (for publication)	L1 M25-275 FR Main ICF French_Public Redacted	1.3
Subject information and informed consent form (for publication)	L1 M25-275 FR Preg Part ICF French_Public	1.0
Subject information and informed consent form (for publication)	L1 M25-275 FR Prescreen ICF French_Public Redacted	1.1
Subject information and informed consent form (for publication)	L1 M25-275 PL ICF Optional_Public redacted	2
Subject information and informed consent form (for publication)	L1 M25-275 PT Main ICF_Public Redacted	4.0
Subject information and informed consent form (for publication)	L1 M25-275 PT Preg Part ICF_Public Redacted	1.0
Subject information and informed consent form (for publication)	L1 M25-275 PT Prescreen ICF_Public Redacted	3.0
Subject information and informed consent form (for publication)	L1 M25-275 SE Main ICF_Public Redacted	1.1
Subject information and informed consent form (for publication)	L1 M25-275 SE Pregnant Parner ICF_Public Redacted	1
Subject information and informed consent form (for publication)	L1 M25-275 SE Prescreening ICF_Public Redacted	1
Subject information and informed consent form (for publication)	L1 M25-275 SE Summary ICF_Public	1
Subject information and informed consent form (for publication)	L1_M25-275 BE Main ICF Dutch_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Main ICF English_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Main ICF French_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Optional ICF Dutch_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Optional ICF English_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Optional ICF French_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Preg Part ICF Dutch_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Preg Part ICF English_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Preg Part ICF French_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Prescreening ICF Dutch_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Prescreening ICF English_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 BE Prescreening ICF French_Public	2.0
Subject information and informed consent form (for publication)	L1_M25-275 IT COMBINED ICF_Public	1.2
Subject information and informed consent form (for publication)	L1_M25-275 IT ICF Pregnant Authorization for data realease_Public	1
Subject information and informed consent form (for publication)	L1_M25-275 IT PRESCREENING ICF_Public	1.2
Subject information and informed consent form (for publication)	L1_M25-275 PL ICF Main_Public redacted	3
Subject information and informed consent form (for publication)	L1_M25-275 PL ICF Pregnancy_Public	2
Subject information and informed consent form (for publication)	L1_M25-275 PL ICF Prescreen_Public redacted	2
Subject information and informed consent form (for publication)	L1_M25-275_DE_ICF Main_German_Public_Redacted	1.2
Subject information and informed consent form (for publication)	L1_M25-275_DE_ICF Pre-Screen_German_Public_Redacted	1.2
Subject information and informed consent form (for publication)	L1_M25-275_DE_ICF Pregnancy_German_Public Redacted	1.2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC-pomalidomide-1-3-4-mg-capsule	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC-pomalidomide-1-3-4-mg-capsule	25
Synopsis of the protocol (for publication)	D1_m25275_protocol_synopsis_redacted	2.2 EU
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis	1.0
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis-BE-DE	1
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis-BE-FR	1.0
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis-BE-NL	1.0
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis-FR	1.0
Synopsis of the protocol (for publication)	D1_m25275_protocol-lay-synopsis-SV	1.0
Synopsis of the protocol (for publication)	D1_m25275_protocol-synopsis-redacted-IT	2.2 EU
Synopsis of the protocol (for publication)	D1_m25275_protocol-synopsis-redacted-PL	2.2 EU
Synopsis of the protocol (for publication)	D1_m25275_protocol-synopsis-redacted-PT	2.2 EU

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-06-12	Italy	Acceptable 2025-10-06	2025-10-06
2	SUBSTANTIAL MODIFICATION	SM-1	2025-11-06		Acceptable	2025-11-25
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-12-08		Acceptable	2025-12-08

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)

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 2

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 3

Exclusion criteria 2

Endpoints

Primary endpoints 2

Secondary endpoints 8

Investigational products

Test 9

Sponsors and contacts

AbbVie Deutschland GmbH & Co. KG

Scientific contact point

Public contact point

Third parties 7

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 54 files

Application history

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