Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
440
Countries
1
Sites
1
Multiple Myeloma
- To characterize the safety, toxicity, and tolerability of etentamig monotherapy or in combination with other agents in participants with multiple myeloma (MM). - To determine the recommended doses of etentamig monotherapy or in combination with other agents in participants with MM.
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Apr 2026 → ongoing
- Decision date (initial)
- 2026-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie
External identifiers
- EU CT number
- 2024-515770-27-00
- ClinicalTrials.gov
- NCT06892522
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Others
- To characterize the safety, toxicity, and tolerability of etentamig monotherapy or in combination with other agents in participants with multiple myeloma (MM).
- To determine the recommended doses of etentamig monotherapy or in combination with other agents in participants with MM.
Secondary objectives 3
- To evaluate the preliminary anti-multiple myeloma (MM) activity of etentamig monotherapy or in combination with other agents.
- To characterize the pharmacokinetics (PK) of etentamig when given alone or in combination with other agents.
- To evaluate the immunogenicity of etentamig.
Conditions and MedDRA coding
Multiple Myeloma
| 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
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes anonymized, individual and trial-level data (analysis data sets), as well as other information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Eastern cooperative oncology group (ECOG) performance of <= 1.
- Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.
- Laboratory values meeting the criteria outlined in the protocol for each substudy within the screening period prior to the first dose of study treatment.
Exclusion criteria 4
- Participant who has known active central nervous system involvement of MM.
- Participant who has known active infection as outlined in the protocol.
- Participant who has known history or other active malignancies within the past 3 years with the exceptions listed in the protocol.
- Participant who has known history of clinically significant (per investigator's judgment) alcohol abuse within the last 6 months.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)
- Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM
- Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM)
- Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM)
- Number of Participants with Adverse Events (AE)s
Secondary endpoints 6
- Substudy 1, 2, 3, 4: Complete Response Rate
- Substudy 1, 2, 3, 4: Progression Free Survival (PFS)
- Substudy 1, 2, 3, 4: Duration of Response (DOR)
- Substudy 1, 2, 3, 4: Overall Response Rate (ORR)
- Substudy 1, 2, 3, 4: Time-to-Progression (TTP)
- Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB175772 · Substance
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
SUB32911 · Substance
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- SOLUTION FOR INFUSION
- 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 4
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| IQVIA AG, Branch Basel ORL-000016068
|
Basel, Switzerland | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Basel, Switzerland | Laboratory analysis |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 10 | 1 |
| Rest of world
Australia, Canada, United Kingdom, Israel, Korea, Republic of, Japan, United States
|
— | 430 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2026-04-27 | 2026-06-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m25059-protocol-public redacted | 3.2(EU) |
| Recruitment arrangements (for publication) | K1 M25-059 NO Recruitment and ICF Procedures | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-059 NO Main ICF SS1_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-059 NO Main ICF SS2_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-059 NO Main ICF SS3_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-059 NO Main ICF SS4_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-059 NO Main ICF_Public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-carfilzomib-updated | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-daratumumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-dexamethasone-iv | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-dexamethasone-tablet | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-lenalidomide | 1 |
| Synopsis of the protocol (for publication) | D1_m25059-euctr-synopsis-EN-EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25059-euctr-synopsis-NO-NO | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-07 | Norway | Acceptable 2026-01-26
|
2026-01-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-17 | Norway | Acceptable 2026-01-26
|
2026-02-17 |