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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clinica Universidad de Navarra
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceActive, not recruiting
L’Hopital Alexandra Lepeve
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Dunkirk Cedex 1FranceActive, not recruiting
Centre Hospitalier Annecy Genevois
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Epagny Metz-tessyFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceActive, not recruiting
Centre Hospitalier Bretagne Atlantique
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VannesFranceActive, not recruiting
Oslo Universitetssykehus HF
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OsloNorwayNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.