Clinical trial • Phase I/II • Oncology
ETENTAMIG for Multiple myeloma
Phase I/II trial of ETENTAMIG for Multiple myeloma. adaptive. 80 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 04-04-2025
- First CTIS Authorization Date
- 08-07-2025
Trial design
adaptive Phase I/II trial across 9 sites in France, Netherlands, Norway.
- Adaptive
- True, dose-escalation design to determine recommended doses of etentamig and iberdomide; no further adaptive rules, interim analyses, or stopping rules described in the provided data.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable population selected (isVulnerablePopulationSelected = true). No detailed information on consent/assent handling is provided in the available CTIS data; subject information and informed consent forms are listed for multiple countries/languages but specifics on assent or age-specific consent documents are not stated..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No detailed information on consent/assent handling is provided in the available CTIS data; subject information and informed consent forms are listed for multiple countries/languages but specifics on assent or age-specific consent documents are not stated.
Inclusion criteria
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1."}
- {"criterion_text":"- Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol."}
- {"criterion_text":"- All participants must have measurable diseases per central laboratory as outlined in protocol"}
Exclusion criteria
- {"criterion_text":"- Has received prior etentamig treatment"}
- {"criterion_text":"- Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide)."}
- {"criterion_text":"- Has received a peripheral ASCT within 12 weeks, or an allogeneic SCT within ≤ 6 months of the first dose of study treatment. Subjects with allogenic stem cell transplant should not have any symptoms of acute or chronic graft versus host disease."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dose-limiting toxicities (DLT) of etentamig when given in combination with Iberdomide in subjects with Relapsed/Refractory Multiple Myeloma.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Response rate (RR): Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), stringent Complete Response (sCR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall Response Rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time-to-progression (TTP)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Minimal Residual Disease (MRD) negativity","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 129
- Consent Approach
- Informed consent obtained; subject information and informed consent forms are provided in multiple country-specific versions (documents listed for Dutch, French, Norwegian). Consent is to be provided by participants; no explicit details on assent or age-specific consent procedures are provided in the available data.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 55
France
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 08-07-2025
- Processing Time Days
- 5
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- 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
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service Hématologie et Thérapie Cellulaire
- Contact Person Name
- Thomas Chalopin
- Contact Person Email
- t.chalopin@chu-tours.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service d'hématologie
- Contact Person Name
- Julien Colle
- Contact Person Email
- julien.colle@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service d'hématologie clinique
- Contact Person Name
- Valentine Richez-Olivier
- Contact Person Email
- richez-olivier.v@chu-nice.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Service d'oncologie médicale
- Contact Person Name
- Pierre Bories
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 14-07-2025
- Processing Time Days
- 14
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Contact Person Name
- Annemiek Broijl
- Contact Person Email
- a.broyl@erasmusmc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematology
- Contact Person Name
- Sonja Zweegman
- Contact Person Email
- hematology@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematology
- Contact Person Name
- Rimke Oostvogels
- Contact Person Email
- r.oostvogels@umcutrecht.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 14-07-2025
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Avdeling for blodsykdommer, Oslo myeloma Center
- Contact Person Name
- Fredrik Schjesvold
- Contact Person Email
- fschjesv@ous-hf.no
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- central laboratory services (sponsorDuties code: 4; contact: jean-paul.lewest@covance.com)
- Name
- Medidata Solutions Inc.
- Responsibilities
- eCOA (electronic clinical outcome assessment)
- Name
- Endpoint Clinical Inc.
- Responsibilities
- operational support (sponsorDuties code: 3)
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4 (as listed in CTIS record)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"sponsorDuties codes: 2 (as listed in CTIS record)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA (responsibility value provided in CTIS record; sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3 (as listed in CTIS record)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Etentamig
- Active Substance
- ETENTAMIG
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus=1 (as listed in CTIS productDictionaryInfo)
- Investigational Product Name
- Iberdomide
- Active Substance
- IBERDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsule); ocular use entry present for one product record
- Route
- Oral
- Authorisation Status
- prodAuthStatus=1 (as listed in CTIS productDictionaryInfo)
- Combination Treatment
- Yes
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