A Phase 1/2 Study of Etentamig in Combination with a CELMoD Agent for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma

2024-512146-41-00 Protocol M24-555 Phase I and Phase II (Integrated) - Other Ongoing, recruiting

Start 29 Jul 2025 · Status Ongoing, recruiting · 3 EU/EEA countries · 9 sites · Protocol M24-555

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ongoing, recruiting
Participants planned 135
Countries 3
Sites 9

Multiple Myeloma

- To characterize the safety, toxicity, and tolerability of etentamig when co-administered with iberdomide in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) - To determine the recommended doses of etentamig and iberdomide combination treatment in subjects with RRMM.

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
29 Jul 2025 → ongoing
Decision date (initial)
2025-07-08
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

- To characterize the safety, toxicity, and tolerability of etentamig when co-administered with iberdomide in subjects with Relapsed/Refractory Multiple Myeloma (RRMM)
- To determine the recommended doses of etentamig and iberdomide combination treatment in subjects with RRMM.

Secondary objectives 2

  1. To evaluate the preliminary anti-Multiple Myeloma activity of etentamig when co-administered with Iberdomide
  2. To characterize the pharmacokinetics (PK) and the immunogenicity of etentamig, as well as the PK of iberdomide and its metabolite M12, when administered in combination as a regimen

Conditions and MedDRA coding

Multiple Myeloma

VersionLevelCodeTermSystem organ class
21.0 LLT 10028228 Multiple myeloma 10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
  2. Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
  3. All participants must have measurable diseases per central laboratory as outlined in protocol

Exclusion criteria 3

  1. Has received prior etentamig treatment
  2. Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
  3. Has received a peripheral ASCT within 12 weeks, or an allogeneic SCT within ≤ 6 months of the first dose of study treatment. Subjects with allogenic stem cell transplant should not have any symptoms of acute or chronic graft versus host disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Dose-limiting toxicities (DLT) of etentamig when given in combination with Iberdomide in subjects with Relapsed/Refractory Multiple Myeloma.

Secondary endpoints 6

  1. Response rate (RR): Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), stringent Complete Response (sCR)
  2. Overall Response Rate (ORR)
  3. Progression-free survival (PFS)
  4. Duration of response (DOR)
  5. Time-to-progression (TTP)
  6. Minimal Residual Disease (MRD) negativity

Investigational products

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

Test 5

Iberdomide

PRD10086308 · Product

Active substance
Iberdomide
Substance synonyms
(3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
Pharmaceutical form
CAPSULE
Route of administration
OCULAR USE
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Iberdomide

PRD10086309 · Product

Active substance
Iberdomide
Substance synonyms
(3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Iberdomide

PRD10086311 · Product

Active substance
Iberdomide
Substance synonyms
(3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Iberdomide

PRD10086310 · Product

Active substance
Iberdomide
Substance synonyms
(3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Authorisation status
Not Authorised
MA holder
CELGENE CORPORATION
Paediatric formulation
No
Orphan designation
No

Etentamig

PRD9603555 · Product

Active substance
Etentamig
Substance synonyms
ABBV-383, Human IgG4 monoclonal antibody against BCMA and CD3, TNB-383B
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
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

138 Total trials 54 Recruiting 80 Ended
Commercial
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 4

OrganisationCity, countryDuties
Labcorp Central Laboratory Services SARL
ORG-100011524
 Basel, Switzerland Laboratory analysis
Massive Bio Inc.
ORG-100044618
 New York, United States Code 2
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other
Endpoint Clinical Inc.
ORG-100040567
 Raleigh, United States Interactive response technologies (IRT)

Locations

3 EU/EEA countries · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 25 5
Netherlands Ongoing, recruiting 15 3
Norway Ongoing, recruiting 15 1
Rest of world
Japan, Canada, Australia, United States
 — 80 —

Investigational sites

France

5 sites · Ongoing, recruiting
Centre Hospitalier Regional De Marseille
Service d'hématologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Regional Universitaire De Tours
Service Hématologie et Thérapie Cellulaire, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nice
Service d'hématologie clinique, 151 Route De Saint Antoine, 06200, Nice
Oncopole Claudius Regaud
Service d'oncologie médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Service des maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex

Netherlands

3 sites · Ongoing, recruiting
Universitair Medisch Centrum Utrecht
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Norway

1 site · Ongoing, recruiting
Oslo University Hospital HF
Avdeling for blodsykdommer, Oslo myeloma Center, Taarnbygget, Kirkeveien 166, Oslo

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-07-29 2025-10-10
Netherlands 2025-09-25 2025-12-18
Norway 2025-09-24 2025-10-16

Results and documents

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

Documents 18 files

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

TypeTitleVersion
Protocol (for publication) D1_m24555-protocol_public_Redacted 4.1 (EU)
Recruitment arrangements (for publication) K1 M24-555 FR Recruitment and ICF Procedures Public 2.0
Recruitment arrangements (for publication) K1_M24-555 NO Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) K1_M24-555_NL_Recruitment and ICF Procedures_Public 1.1
Subject information and informed consent form (for publication) L1 M24-555 FR Preg Part ICF French_Public 2.0
Subject information and informed consent form (for publication) L1 M24-555 NO ICF Optional Public 5
Subject information and informed consent form (for publication) L1 M24-885 NO ICF Pregnant Partner Public 2
Subject information and informed consent form (for publication) L1_M24-555 FR ICF Main ICF_Public 2.1
Subject information and informed consent form (for publication) L1_M24-555 NO ICF Main Public 5
Subject information and informed consent form (for publication) L1_M24-555_NL_ICF Main_Public 2.1
Subject information and informed consent form (for publication) L1_M24-555_NL_ICF Optional_Public 2.1
Subject information and informed consent form (for publication) L1_M24-555_NL_ICF Pregnancy_Public 1.1
Subject information and informed consent form (for publication) L2 M24-555 FR Info Given to Subjects French_Public 8
Subject information and informed consent form (for publication) L2_M24-555_NL_Other Subject Information Material Pregnancy prevention Plan 8
Synopsis of the protocol (for publication) D1_m24555-euctr-synopsis-EN-EN 1
Synopsis of the protocol (for publication) D1_m24555-euctr-synopsis-FR-FR 1
Synopsis of the protocol (for publication) D1_m24555-euctr-synopsis-NL-NL 1
Synopsis of the protocol (for publication) D1_m24555-euctr-synopsis-NO-NO 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-04-04 France Acceptable
2025-07-08
 2025-07-08
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-12 France Acceptable
2026-03-17
 2026-03-17

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