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A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Study acronym: LINKER-MM3
StatusRecruiting
PhasePhase 3
Started2023-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-03-05
Study Status, Contacts/Locations v46
Study sites158→159
2026-01-26
Study Status, Contacts/Locations v45
Study sites158 entries, revised
Hospital A Beneficencia Portuguesa de Sao Paulo, Oncology House Hopital Saint Antoine Hospital
2025-10-29
Study Status, Contacts/Locations v44
Study sitesdetails revised at 6 of 158 sites
2025-10-09
Study Status, Contacts/Locations v43
Study sitesdetails revised at 1 of 158 sites
2025-09-17
Study Status, Contacts/Locations v42
Study sites157→158
Show 41 earlier versions
2025-09-15
Study Status, Contacts/Locations v41
Study sites157 entries, revised
Clinica Universidad de Navarra - Pamplona
2025-07-24
Study Status, Contacts/Locations v40
Study sitesdetails revised at 18 of 157 sites
2025-06-23
Study Status, Contacts/Locations v39
Study sites157 entries, revised
University of Florida Division of Sponsored Programs
2025-06-16
Study Identification, Study Status, Study Design, Arms and Interventions, Contacts/Locations, IPDSharing v38
Enrollment target380→410
Study sitesdetails revised at 22 of 157 sites
2025-05-12
Study Status, Contacts/Locations v37
Study sites156→157
2025-04-09
Study Status, Contacts/Locations v36
Study sites155→156
2025-03-18
Study Status, Contacts/Locations v35
Study sites153→155
2025-03-07
Study Status, Contacts/Locations v34
Study sites151→153
2025-02-19
Study Status, Contacts/Locations v33
Study sites150→151
2025-02-11
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v32
Primary completion date2032-12-26→2033-04-19
Completion date2032-12-26→2033-04-19
Study sites145→150
Eligibility criteria+112 characters
[...] criteria, as described in the protocol Adequate hematologic function and hepatic function within 7 days of randomization, hepatic,as well as adequate renal and cardiac function, asand wellcorrected as evidence of adequate bone marrow reservescalcium Life expectancy of at least 6 months Key Exclusion Criteria [...] condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism). Any infection requiring hospitalization or treatment with [...] r another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction <40%. NOTE: Other protocol defined inclusi [...]
Secondary endpoints63 entries, revised
Objective Response (OR) of PartialComplete Response (PRCR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants OR of CompletePartial Response (CRPR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
2025-01-08
Study Status, Contacts/Locations v31
Study sites138→145
2024-12-09
Study Status, Contacts/Locations v30
Study sites135→138
2024-12-02
Study Status, Contacts/Locations v29
Study sites132→135
2024-11-21
Study Status, Contacts/Locations, References v28
Study sites128→132
2024-11-01
Study Status, Contacts/Locations v27
Study sites126→128
2024-10-16
Study Status, Contacts/Locations v26
Study sitesdetails revised at 2 of 126 sites
2024-10-03
Study Status, Contacts/Locations v25
Study sites123→126
2024-09-30
Study Status, Contacts/Locations v24
Study sites122→123
2024-09-16
Study Status, Contacts/Locations v23
Study sites120→122
2024-09-03
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 120 sites
2024-08-12
Study Status, Contacts/Locations v21
Study sites113→120
2024-07-22
Study Status, Contacts/Locations v20
Study sites110→113
2024-07-11
Study Status, Contacts/Locations v19
Study sites103→110
2024-07-01
Study Status, Contacts/Locations v18
Study sites88→103
2024-06-06
Study Status, Contacts/Locations v17
Study sites85→88
2024-05-31
Study Status, Contacts/Locations v16
Study sites76→85
2024-05-20
Study Status, Contacts/Locations v15
Study sites66→76
2024-04-29
Study Status, Contacts/Locations v14
Study sites63→66
2024-04-22
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v13
Enrollment target300→380
Study sites51→63
Eligibility criteria+177 characters
[...] otherapies Note: BCMA antibody-drug conjugates are allowed. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder. Any infection requiring hospitalization or treatment with IV [...]
Secondary endpoints63 entries, revised
Objective Response (OR) of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants OR of Very Good Partial Response (VGPR) [...] ter per IMWG response criteria as determined by IRC in CD38 antibody exposed participants OR of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants Incidence of minimal residual disease ( [...] ) negative status in participants previously exposed to CD38 antibodies Overall Survival (OS) in participants previously exposed to CD38 antibodies Mean chang [...] [...]
Primary endpoints1 entry, revised
[...] ia determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
2024-03-26
Study Status, Contacts/Locations v12
Study sites44→51
2024-02-23
Study Status, Contacts/Locations v11
Study sites37→44
2024-02-16
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v10
Enrollment target286→300
Study sites30→37
Eligibility criteria+479 characters
[...] t be lenalidomide refractory, as described in the protocol. Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody. Patients must have measurable disease for response assessmen [...] nsplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be a [...] [...]
Secondary endpoints31 to 63 entries
PFS per IMWG response criteria determined by IRC in all participants Objective Response (OR) greater or equal toof Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 exposed participants OR of PR or better per IMWG response criteria as determined by the IRC in all participants ObjectiveOR Response Rate (ORR) greater or equal toof Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 exposed participants OR of VGPR or better per IMWG response criteria as determined by IRC in all participants ObjectiveOR Respo [...] [...]
Primary endpoints1 entry, revised
[...] se criteria determined by Independent Review Committee (IRC) in CD38 exposed participants
Study title-7 characters
A StudyTrial to Learn How Well Linvoseltamab (REGN5458) Will WorkWorks Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone (EPd)for Combination, inAdult Participants With Relapsed/Refractory Multiple Myeloma
2024-01-23
Study Status, Contacts/Locations v9
Study sites24→30
2024-01-04
Study Status, Contacts/Locations v8
Study sites15→24
2023-11-30
Study Status, Contacts/Locations v7
Study sites10→15
2023-11-27
Study Status, Contacts/Locations v6
Study sites7→10
2023-11-10
Study Status, Contacts/Locations v5
Study sites1→7
2023-10-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2023-09-01
Study Identification, Study Status v3
Start date2023-08-04→2023-09-18
Study titlerevised
A Study to Learn How Linvoseltamab (REGN5458) Will Work Compared to the Elotuzumab, PomalidimidePomalidomide and Dexamethasone (EPd) Combination, in Participants With Relapsed/Refractory Multiple Myeloma
2023-06-15
Study Status v2
Primary completion date2032-10-22→2032-12-26
Completion date2032-10-22→2032-12-26
Start date2023-05-31→2023-08-04
2023-04-17
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsDexamethasone (Drug), Elotuzumab (Drug), Pomalidomide (Drug), REGN5458 (Drug)→Dexamethasone (Drug), Elotuzumab (Drug), Linvoseltamab (Drug), Pomalidomide (Drug)
Eligibility criteria+118 characters
Key Inclusion Criteria: Age 18 years or older (or legal adult age in the country) at the time of the screening visit. Eastern Cooperative Oncology Group (ECOG) performance status [...] tients with ECOG 2 solely due to local symptoms of myeloma (e.geg. pain) may be allowed after discussion with the Medical Mon [...] egaly, endocrinopathy, monoclonal protein, and skin changes). Prior treatment with elotuzumab and/or pomalidomide Partici [...] ection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the proto [...]
Secondary endpoints29 to 31 entries
Objective Response (OR) greater or equal to Partial Response (PR) per IMWG response criteria as determined by the IRC ORR greater or equal to PR per IMWG response criteria as determined by the investigator ORR greater or equal to VGPR per IMWG response criteria as determined by the investigator ORR greater or equal to CR per IMWG response criteria as determined by the investigator Duration of Response (DoR) as per IMWG response criteria as determined by the investigator DoR as per IMWG response criteria as determined by the IRC Time from randomization to objective response (≥PR) as per IMWG re [...] [...]
2023-02-06
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd
Trial Details
NCT Number NCT05730036
Lead Sponsor Regeneron Pharmaceuticals
Conditions Relapsed Refractory Multiple Myeloma (RRMM)
Enrollment 410 participants
Start Date 2023-09-18
Primary Completion 2033-04-19 (estimated)
Study Completion 2033-04-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-30