A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Overview

Sponsor-declared trial summary

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

25 Feb 2026 → ongoing

Decision date (initial)

2026-02-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

Phase 2: To determine the RP3D of etentamig in combination with daratumumab in partcipants with Newly Diagnosed Multiple Myeloma (NDMM) that are not eligible for transplant
Phase 3: To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant
To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant

Secondary objectives 5

1. Phase 2: To determine safety and tolerability of etentamig in combination with daratumumab in participants with NDMM that are not eligible for transplant
2. Phase 2: To determine the clinical activity of etentamig in combination with daratumumab in participants with NDMM that are not eligible for transplant
3. Phase 2: To determine the pharmacokinetics and immunogenicity of etentamig when given in combination with daratumumab in participants with NDMM that are not eligible for transplant
4. Phase 3: To further evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant
5. Phase 3: To further evaluate the safety and tolerability of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant

Conditions and MedDRA coding

Multiple Myeloma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

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 4

1. Participants must have confirmed NDMM according to the IMWG diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
2. International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of ≥ 1
3. Eastern Cooperative Oncology Group (ECOG) performance of ≤1
4. 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 (≥ 5 g/L). • Urine M-protein ≥ 200 mg/24 hours. • Serum free light chain (FLC) ≥ 100 mg/L (≥ 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.

Exclusion criteria 5

1. Prior or current systemic therapy or SCT for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
2. Participants received treatment with anti-cancer therapy (including chemotherapy, radiotherapy, biologics, immunotherapy, cellular therapies and/or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days or within 5 half-lives of an anticancer therapy, prior to the first dose of study treatment, whichever is shorter
3. Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
4. Participant who has known active central nervous system involvement of Multiple Myeloma (MM)
5. Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Phase 2: Clinical activity as determined by International Myeloma Working Group (IMWG (2016) response rates [Overall Response Rate (ORR), Complete Response (CR) or better, Very Good Partial Response (VGPR), Partial Response (PR)]
2. Phase 3: Minimal Residual Disease (MRD) negative CR rate
3. Phase 3: Progression-Free Survival (PFS)

Secondary endpoints 29

1. Phase 2: MRD negative CR rate
2. Phase 2: PFS
3. Phase 2: Sustained MRD negativity rate (12 months)
4. Phase 2: Overall Survival (OS)
5. Phase 2: Safety and Tolerability
6. Phase 2: Maximum Observed Serum Concentration (Cmax)
7. Phase 2: Time to Cmax (time to maximum observed concentration, Tmax)
8. Phase 2: Area Under the Serum Concentration-Time Curve (AUC)
9. Phase 2: Positive or negative anti-drug antibodies (ADAs) and neutralizing anti-drug antibodies (NAbs)
10. Phase 3: OS
11. Phase 3: Sustained MRD negativity rate (12 months)
12. Phase 3: Rate of ≥ CR
13. Phase 3: Rate of ≥ VGPR or better
14. Phase 3: ORR
15. Phase 3: Time to Response (TTR)
16. Phase 3: Duration of Response (DOR)
17. Phase 3: Time-to-progression (TTP)
18. Phase 3: Duration of Response (DOR)
19. Phase 3: Time-to-progression (TTP)
20. Phase 3: Event Free Survival (EFS)
21. Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2)
22. Phase 3: Safety and tolerability
23. Phase 3: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning score
24. Phase 3: Change from baseline in EORTC QLQ-C30 Global Health Status/QoL score
25. Phase 3: Change from baseline and time to deterioration in the remaining scales and items of EORTC QLQ-C30
26. Phase 3: Symptomatic AEs as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
27. Phase 3: Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5
28. Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) scores
29. Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) scores

Investigational products

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

Test 1

Comparator 9

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

Locations

3 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 20 files

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

Application history

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