Multiple MyelomaPhase 3NCT06932562
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
A Phase 3 study testing Linvoseltamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 59 sites in 18 countries.
Trial summary
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Linvoseltamab, Daratumumab and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 59 sitesin 18 countries
- Study dates
- 23 Dec 2025to Dec 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have clinical laboratory values within a prespecified range.
Who cannot join
- International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
- Participants who defer transplant due to personal preference.
- Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
- Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
- focal radiation and/or
- a short course of corticosteroids as defined in the protocol.
Show all 12Show fewer
- Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
- Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1.
- Participants who have uncontrolled intercurrent illness.
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
- NOTE Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
59 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 18 countries
Italy11 sites, 11 recruiting
- Recruiting
AOU Ospedali Riuniti di Ancona
Ancona
Offidani
- Recruiting
Azienda Ospedaliera Santa Croce e Carle - Ematologia
Cuneo
Celeghini
- Recruiting
A.O.U. Careggi
Florence
Antonioli
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
Aquino
- Recruiting
Ospedale di Legnano, ASST Ovest Milanese
Legnano
Rezzonico
- Recruiting
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola
Cerchione
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
Cafro
- Recruiting
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia
Milan
Bolli
- Recruiting
Azienda USL IRCCS Di Reggio Emilia
Reggio
Gamberi
- Recruiting
Ospedale "Infermi" di Rimini
Rimini
Rotondo
- Recruiting
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Carella
Australia8 sites, 8 recruiting
- Recruiting
Flinders Medical Centre
Adelaide
Sobieraj-Teague
- Recruiting
Box Hill Hospital
Box Hill
Motorna
- Recruiting
Canberra Hospital
Canberra
Joshi
- Recruiting
Barwon Health, University Hospital Geelong
Geelong
Campbell
- Recruiting
Austin Hospital
Heidelberg
Hocking
- Recruiting
Nepean Cancer Centre
Kingswood
Ponraj
- Recruiting
Northern Hospital
Melbourne
Cooke
- Recruiting
Sunshine Coast Health
Sunshine Coast
Wallington-Gates
Spain5 sites, 5 recruiting
- Recruiting
Institut Catala D'oncologia (Badalona)
Badalona
Ibarra
- Recruiting
Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit
Barcelona
Laura Rosiñol Dachs, MD
- Recruiting
Hospital Quirón Salud Madrid
Madrid
Martinez Chamorro
- Recruiting
Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service
Santander
Enrique Ocio San Miguel, MD
- Recruiting
Hospital Universitario la Fe, Valencia
Valencia
de la Rubia
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Radocha
- Recruiting
University Hospital Olomouc
Olomouc
Minarik
- Recruiting
Fakultni Nemocnice Ostrava
Ostrava
Hajek
- Recruiting
Fakultni Nemocnice Plzen
Pilsen
Jungova
Greece4 sites, 4 recruiting
- Recruiting
University Hospital of Alexandroupolis
Alexandroupoli
Spanoudakis
- Recruiting
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens
Evangelos Terpos
- Recruiting
Evaggelismos Hospital
Athens
Delimpasi
- Recruiting
Theagenion Cancer Hospital
Thessaloniki
Katodritou
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Ankara University Faculty of Medicine, Department of Hematology
Ankara
Cengiz Seval
- Recruiting
Liv Hospital Ankara
Ankara
Beksac
- Recruiting
Ege Universitesi Tip Fakultesi - Hematology
Izmir
Vural
- Recruiting
Ege University Medicine Faculty, Izmir
Izmir
Comert
Germany3 sites, 3 recruiting
- Recruiting
Universitaetsmedizin Greifswald
Greifswald
Krönke
- Recruiting
Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie
Lübeck
Leitner
- Recruiting
University Hospital of Würzburg
Würzburg
Waldschmidt
Ireland3 sites, 3 recruiting
- Recruiting
Cork University Hospital
Cork
Mykytiv
- Recruiting
Beaumont Hospital
Dublin
Quinn
- Recruiting
University Hospital Limerick - Department of Haematology
Limerick
Clifford
Norway3 sites, 3 recruiting
- Recruiting
Stavanger University Hospital
Stavanger
Haukås
- Recruiting
Vestfold Hospital Trust
Tønsberg
Moksnes
- Recruiting
St. Olavs hospital HF
Trondheim
Slørdahl
Austria2 sites, 2 recruiting
- Recruiting
Ordensklinikum Linz
Linz
Strassl
- Recruiting
Klinik Ottakring
Vienna
Schreder
Estonia2 sites, 2 recruiting
- Recruiting
North Estonia Medical Centre Foundation
Tallinn
Loigom
- Recruiting
Tartu University Hospital
Tartu
Pärnat
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital Comprehensive Cancer Center
Helsinki
Söderholm
- Recruiting
Kuopio University Hospital
Kuopio
Partanen
Portugal2 sites, 2 recruiting
- Recruiting
CHUC
Coimbra
Roque
- Recruiting
Hospital da Luz Lisboa
Lisbon
Pedrosa
Switzerland2 sites, 2 recruiting
- Recruiting
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel
Heim
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Lehmann
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Zagreb - Clinic for Internal Medicine
Zagreb
Basic-Kinda
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus
Ølholm Vase
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital, Region Skåne
Lund
Lemonakis
About this study
Official title: A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Linvoseltamab, Daratumumab, Lenalidomide, Dexamethasone
- Keywords
- Multiple Myeloma (MM), Transplant ineligible, Newly diagnosed, Linvoseltamab, BCMA X CD3 bispecific antibody, CD38 antibody, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinvoseltamabDrug
Also called REGN5458
Administered per the protocol
DaratumumabDrug
Administered per the protocol
LenalidomideDrug
Administered per the protocol
DexamethasoneDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Control arm DRd | Active comparator | Not described Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
| Experimental Arm DRd+ linvolsetamab | Experimental | Not described Receives: Drug: Linvoseltamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD) negative Complete Remission (CR) status at 10^-5 per International Myeloma Working Group (IMWG) criteria
Measured: up to 11 years
MRD negative CR status by BICR
MRD negative CR status at 10^-5 as determined by the Blinded Independent Central Review (BICR)
Measured: up to 11 years
Progression Free Survival (PFS) per IMWG criteria
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
Measured: up to 11 years
PFS as determined by BICR
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR.
Measured: up to 11 years
Secondary outcomes (25)
Overall Survival (OS)
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Measured: up to 11 years
Objective Response (OR) of Complete Response (CR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for Complete Response (CR) or better
Measured: up to 11 years
OR of Very Good Partial Response (VGPR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for VGPR or better
Measured: up to 11 years
OR of Partial Response (PR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for PR or better
Measured: up to 11 years
Sustained MRD
Sustained MRD negative CR (sMRD) at 10^-5 per IMWG criteria
Measured: up to 11 years
Duration of response (DOR) of stringent (s)CR
duration of response to best overall response of stringent sCR, per IMWG response criteria
Measured: up to 11 years
Duration of response (DOR) of CR
duration of response to best overall response of CR, per IMWG response criteria
Measured: up to 11 years
Duration of response (DOR) of VGPR
duration of response to best overall response of VGPR, per IMWG response criteria
Measured: up to 11 years
Duration of response (DOR) of PR
duration of response to best overall response of PR, per IMWG response criteria
Measured: up to 11 years
Time to response ≥CR
Time from randomization to objective response (≥CR) as per IMWG response criteria
Measured: up to 11 years
Time to response ≥VGPR
Time from randomization to objective response (≥VGPR) as per IMWG response criteria
Measured: up to 11 years
Time to response ≥PR
Time from randomization to objective response (≥PR) as per IMWG response criteria
Measured: up to 11 years
Disease progression
Time to disease progression per IMWG response criteria
Measured: up to 11 years
Incidence of TEAEs
Incidence of treatment emergent adverse events (TEAEs)
Measured: up to 11 years
Severity of TEAEs
Severity of treatment emergent adverse events (TEAEs)
Measured: up to 11 years
Serious Adverse Events
Incidence of Serious Adverse Events (SAE)
Measured: up to 11 years
Concentrations of linvoseltamab
Concentrations of linvoseltamab in serum over time
Measured: up to 11 years
Incidence antidrug antibodies
Incidence of antidrug antibodies (ADAs) to linvoseltamab
Measured: up to 11 years
Titer of ADA
Titer of ADA to linvoseltamab
Measured: up to 11 years
EORTC QLQ-C30 Global Health Status / Quality of Life
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported quality of life using one global health status/quality of life (GHS/QoL) scale, 5 functioning scales (physical, role, emotional, cognitive, and social) ranging from from 1 = "very poor" to 7 = "excellent" and 9 symptom scales/items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer, ranging from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
Measured: up to 11 years
EORTC QLQ-C30 Physical Functioning (PF)
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire functioning scale Physical Functioning (PF). PF scale consist of 5 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher ("better") level of functioning
Measured: up to 11 years
EORTC QLQ-C30 Role Functioning (RF)
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire functioning scale Role Functioning (RF). RF scale consist of 2 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher ("better") level of functioning
Measured: up to 11 years
EORTC QLQ-C30 Pain
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire symptom scale Pain. Pain scale consist of 2 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden
Measured: up to 11 years
EORTC QLQ-C30 Fatigue
Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire symptom scale Fatigue. Fatigue scale consist of 3 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden
Measured: up to 11 years
EQ-5D-5L VAS
Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS).
The EQ-5D-5L is a generic questionnaire that measures Health-Related Quality of Life (HRQoL) across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (1= no problems, 2= slight problems, 3= some problems, 4= severe problems and 5= extreme problems), higher scores indicate lower health states And a visual analogue scale (VAS). VAS scale ranging from 0 = "worst" to 100 = "best" higher score indicate higher health status
Measured: up to 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start23 Dec 2025
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Roberto Mina, Principal investigator, A.O.U. Città della Salute e della Scienza di TorinoClaudia Stege, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932562
- Sponsor's protocol ID
- EMN39
- Other IDs
- 2024-519827-16-00
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT06932562
- Acronym / sponsor ID
- EMN39
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma (MM), Transplant ineligible, Newly diagnosed, Linvoseltamab, BCMA X CD3 bispecific antibody, CD38 antibody, Lenalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm DRd | Active comparator | Drug: Daratumumab, Drug: Lenalidomide, Drug: Dexamethasone |
| Experimental Arm DRd+ linvolsetamab | Experimental | Drug: Linvoseltamab, Drug: Daratumumab, Drug: Lenalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
- Participants must have measurable disease as defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have clinical laboratory values within a prespecified range.
Key exclusion criteria (12 listed)
- International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
- Participants who defer transplant due to personal preference.
- Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
- Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
- Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinvoseltamabAlso: REGN5458Administered per the protocol | Drug | Experimental Arm DRd+ linvolsetamab |
| DaratumumabAdministered per the protocol | Drug | Control arm DRd, Experimental Arm DRd+ linvolsetamab |
| LenalidomideAdministered per the protocol | Drug | Control arm DRd, Experimental Arm DRd+ linvolsetamab |
| DexamethasoneAdministered per the protocol | Drug | Control arm DRd, Experimental Arm DRd+ linvolsetamab |
Primary outcome
Minimal Residual Disease (MRD)
Time frame: up to 11 years
Minimal Residual Disease (MRD) negative Complete Remission (CR) status at 10^-5 per International Myeloma Working Group (IMWG) criteria
MRD negative CR status by BICR
Time frame: up to 11 years
MRD negative CR status at 10^-5 as determined by the Blinded Independent Central Review (BICR)
Progression Free Survival (PFS) per IMWG criteria
Time frame: up to 11 years
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
PFS as determined by BICR
Time frame: up to 11 years
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR.
25 secondary outcomes
Overall Survival (OS)
Time frame: up to 11 years
Objective Response (OR) of Complete Response (CR)
Time frame: up to 11 years
OR of Very Good Partial Response (VGPR)
Time frame: up to 11 years
OR of Partial Response (PR)
Time frame: up to 11 years
Sustained MRD
Time frame: up to 11 years
Duration of response (DOR) of stringent (s)CR
Time frame: up to 11 years
Duration of response (DOR) of CR
Time frame: up to 11 years
Duration of response (DOR) of VGPR
Time frame: up to 11 years
Duration of response (DOR) of PR
Time frame: up to 11 years
Time to response ≥CR
Time frame: up to 11 years
Time to response ≥VGPR
Time frame: up to 11 years
Time to response ≥PR
Time frame: up to 11 years
Disease progression
Time frame: up to 11 years
Incidence of TEAEs
Time frame: up to 11 years
Severity of TEAEs
Time frame: up to 11 years
Serious Adverse Events
Time frame: up to 11 years
Concentrations of linvoseltamab
Time frame: up to 11 years
Incidence antidrug antibodies
Time frame: up to 11 years
Titer of ADA
Time frame: up to 11 years
EORTC QLQ-C30 Global Health Status / Quality of Life
Time frame: up to 11 years
EORTC QLQ-C30 Physical Functioning (PF)
Time frame: up to 11 years
EORTC QLQ-C30 Role Functioning (RF)
Time frame: up to 11 years
EORTC QLQ-C30 Pain
Time frame: up to 11 years
EORTC QLQ-C30 Fatigue
Time frame: up to 11 years
EQ-5D-5L VAS
Time frame: up to 11 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Mina principal investigator
A.O.U. Città della Salute e della Scienza di Torino
Claudia Stege principal investigator
Erasmus Medical Center
59 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linvoseltamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 59 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Italy, Australia, Spain, Czechia, Greece and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Villa (+31 10 268 70 65, silvia.villa@emn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD) (time frame: up to 11 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.