Clinical trial • Phase II/III • Oncology

ETENTAMIG for Multiple myeloma

Phase II/III trial of ETENTAMIG for Multiple myeloma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Multiple myeloma
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
15-10-2025
First CTIS Authorization Date
18-02-2026

Trial design

Randomised, open-label, etentamig + daratumumab (investigational arm); comparator arm: daratumumab, lenalidomide, and dexamethasone (drd). doses and schedules not specified in the available ctis data.-controlled, adaptive Phase II/III trial in Spain, Norway, France.

Randomised
Yes
Open Label
Yes
Comparator
Etentamig + Daratumumab (investigational arm); Comparator arm: Daratumumab, Lenalidomide, and Dexamethasone (DRd). Doses and schedules not specified in the available CTIS data.
Adaptive
True, Phase 2 objective includes determination of RP3D of etentamig in combination with daratumumab (dose-escalation element to determine recommended phase 3 dose).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
36

Eligibility

Recruits 36 Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial population is adult participants; no specific consent/assent handling for vulnerable or paediatric populations is described in the available CTIS entries..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial population is adult participants; no specific consent/assent handling for vulnerable or paediatric populations is described in the available CTIS entries.

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of ≥ 1"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance of ≤1"}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Prior or current systemic therapy or SCT for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Participant who has known active central nervous system involvement of Multiple Myeloma (MM)"}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- 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)]","definition_or_measurement_approach":"Clinical activity determined by IMWG (2016) response rates (ORR, CR or better, VGPR, PR) as specified in endpoint text."}
  • {"endpoint_text":"- Phase 3: Minimal Residual Disease (MRD) negative CR rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Progression-Free Survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Phase 2: MRD negative CR rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 2: PFS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 2: Sustained MRD negativity rate (12 months)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 2: Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 2: Safety and Tolerability","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 2: Maximum Observed Serum Concentration (Cmax)","definition_or_measurement_approach":"Pharmacokinetic measurement: Cmax"}
  • {"endpoint_text":"- Phase 2: Time to Cmax (time to maximum observed concentration, Tmax)","definition_or_measurement_approach":"Pharmacokinetic measurement: Tmax"}
  • {"endpoint_text":"- Phase 2: Area Under the Serum Concentration-Time Curve (AUC)","definition_or_measurement_approach":"Pharmacokinetic measurement: AUC"}
  • {"endpoint_text":"- Phase 2: Positive or negative anti-drug antibodies (ADAs) and neutralizing anti-drug antibodies (NAbs)","definition_or_measurement_approach":"Immunogenicity assessment: ADA and NAb status"}
  • {"endpoint_text":"- Phase 3: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Sustained MRD negativity rate (12 months)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Rate of ≥ CR","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Rate of ≥ VGPR or better","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: ORR","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Time to Response (TTR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Duration of Response (DOR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Time-to-progression (TTP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Duration of Response (DOR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Time-to-progression (TTP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Event Free Survival (EFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Progression-Free Survival on Subsequent Therapy (PFS2)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Safety and tolerability","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Phase 3: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning score","definition_or_measurement_approach":"Quality of life assessed using EORTC QLQ-C30 Physical Functioning score"}
  • {"endpoint_text":"- Phase 3: Change from baseline in EORTC QLQ-C30 Global Health Status/QoL score","definition_or_measurement_approach":"Quality of life assessed using EORTC QLQ-C30 Global Health Status/QoL score"}
  • {"endpoint_text":"- Phase 3: Change from baseline and time to deterioration in the remaining scales and items of EORTC QLQ-C30","definition_or_measurement_approach":"Quality of life assessed using remaining EORTC QLQ-C30 scales/items"}
  • {"endpoint_text":"- Phase 3: Symptomatic AEs as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","definition_or_measurement_approach":"Patient-reported symptomatic adverse events measured by PRO-CTCAE"}
  • {"endpoint_text":"- Phase 3: Overall bother due to treatment side effects as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) GP5","definition_or_measurement_approach":"Patient-reported overall bother measured by FACT-G GP5"}
  • {"endpoint_text":"- Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) scores","definition_or_measurement_approach":"Patient-reported severity via PGIS"}
  • {"endpoint_text":"- Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) scores","definition_or_measurement_approach":"Health-related quality of life measured by EQ-5D-5L"}

Recruitment

Planned Sample Size
36
Recruitment Window Months
188
Consent Approach
Informed consent is required from adult participants. Country-specific main ICFs are provided (documents present for Spain, France, Norway). Optional research ICF and a pregnant partner ICF are listed for some countries. No paediatric/assent procedures or other special vulnerable-population consent arrangements are described in the available CTIS entries.

Geography

Total Number Of Sites
30
Total Number Of Participants
24

Spain

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
15
Number Of Sites
13
Number Of Participants
7

Sites

Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hematology
Contact Person Name
Alexia Teresa Suárez Cabrera
Contact Person Email
asuacab@gobiernodecanarias.org
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Contact Person Name
Gladys Ibarra
Contact Person Email
gibarra@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology and Hemotherapy
Contact Person Name
Javier de la Rubia
Contact Person Email
delarubia_jav@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Maria Jesus Blanchard
Contact Person Email
mjesusblanchard@yahoo.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Laura Rosinol Dachs
Contact Person Email
lrosinol@clinic.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Contact Person Name
Maria Victoria Mateos Manteca
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Contact Person Name
Joaquin Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Hematology
Contact Person Name
Marta Sonia Gonzalez Perez
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Contact Person Name
Enrique Ocio San Miguel
Contact Person Email
ocioem@unican.es
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Hospital Universitario De Leon
Department Name
Hematology
Contact Person Name
Fernando Escalante Barrigon
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology and Hemotherapy
Contact Person Name
Cristina Encinas

Norway

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Avdeling for blodsykdommer, Oslo myeloma center
Contact Person Name
Fredrik Schjesvold
Contact Person Email
fschjesv@ous-hf.no

France

Earliest CTIS Part Ii Submission Date
09-02-2026
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
66
Number Of Sites
16
Number Of Participants
16

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology and cell therapy
Contact Person Name
Thomas CHALOPIN
Contact Person Email
t.chalopin@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service Hématologie et Thérapie cellulaire, PRC
Contact Person Name
Xavier LELEU
Contact Person Email
xavier.leleu@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Clinical Hematology
Contact Person Name
Laure VINCENT
Contact Person Email
l-vincent@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology
Contact Person Name
Cyrille TOUZEAU
Contact Person Email
cyrille.touzeau@chu-nantes.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Hematology
Contact Person Name
Frédérique ORSINI-PIOCELLE
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of clinical Hematology and Cell Therapy
Contact Person Name
Cyrille HULIN
Contact Person Email
cyrille.hulin@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Clinical Hematology and Cellular Therapy
Contact Person Name
Emilie CHALAYER
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Contact Person Name
Clarisse CAZELLES
Contact Person Email
clarisse.cazelles@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology
Contact Person Name
Aurore PERROT
Contact Person Email
perrot.aurore@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Institut d'hématologie de basse Normandie
Contact Person Name
Margaret MACRO
Contact Person Email
macro-m@chu-caen.fr
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Hematology and immunology department
Contact Person Name
Pascal GODMER
Site Name
L'Hopital Alexandra Lepeve
Department Name
Hematology
Contact Person Name
Hélène DEMARQUETTE
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Immuno-Hematology
Contact Person Name
Alexis TALBOT
Contact Person Email
alexis.talbot@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des maladies du sang
Contact Person Name
Salomon MANIER
Contact Person Email
salomon.manier@chru-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology and cell therapy
Contact Person Name
Mohamad MOHTY
Contact Person Email
Mohamad.mohty@inserm.fr
Site Name
Hospices Civils De Lyon
Department Name
Hematology
Contact Person Name
Lionel KARLIN
Contact Person Email
Lionel.karlin@chu-lyon.fr

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Third parties

  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"code 15; Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"code 15; Independent Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"code 15; Central Imaging Review","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Etentamig
Active Substance
ETENTAMIG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
1
Investigational Product Name
DARATUMUMAB
Active Substance
DARATUMUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
2
Investigational Product Name
LENALIDOMIDE
Active Substance
LENALIDOMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Investigational Product Name
DEXAMETHASONE
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
ORAL USE; INTRAVENOUS ADMINISTRATION
Route
ORAL USE; INTRAVENOUS ADMINISTRATION
Authorisation Status
2
Combination Treatment
Yes

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