NCT07095452Active, not recruitingPhase 2/3
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
A Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 15 Oct 2025
- Start date
- 25 Feb 2026
- Lead sponsor
- AbbVie Deutschland GmbH & Co. KG
- Diseases
- Multiple myeloma
- EU CT number
- 2025-520897-21-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 24
- 28 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current systemic therapy or SCT for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
- 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
- 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
Other illness
- 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
Other
- Participant who has known active central nervous system involvement of Multiple Myeloma (MM)
Who the study is looking for
- 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.
- International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of ≥ 1
- Eastern Cooperative Oncology Group (ECOG) performance of ≤1
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Active, not recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Active, not recruiting |
| L’Hopital Alexandra Lepeve Coordinator of this site? Confirm its status | Dunkirk Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Epagny Metz-tessy | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Active, not recruiting |
| Centre Hospitalier Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Active, not recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.