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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05730036
Registration number
NCT05730036
Ethics application status
Date submitted
6/02/2023
Date registered
15/02/2023
Date last updated
7/06/2024
Titles & IDs
Public title
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
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Scientific title
An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
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Secondary ID [1]
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2022-501396-62-00
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Secondary ID [2]
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R5458-ONC-2245
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Universal Trial Number (UTN)
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Trial acronym
LINKER-MM3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed Refractory Multiple Myeloma (RRMM)
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Linvoseltamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Experimental: Linvoseltamab - Randomization 1:1
Active Comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd) - Randomization 1:1
Treatment: Drugs: Linvoseltamab
REGN5458 will be administered by intravenous (IV) infusion
Treatment: Drugs: Elotuzumab
Elotuzumab will be administered by IV infusion
Treatment: Drugs: Pomalidomide
Pomalidomide capsules will administered by mouth (PO)
Treatment: Drugs: Dexamethasone
Dexamethasone tablets/capsules will be administered PO and/or by IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
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Assessment method [1]
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Timepoint [1]
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Up to approximatively 5 years
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Secondary outcome [1]
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PFS per IMWG response criteria determined by IRC in all participants
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Assessment method [1]
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Timepoint [1]
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Up to approximatively 5 years
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Secondary outcome [2]
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Objective Response (OR) of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants
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Assessment method [2]
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Timepoint [2]
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Up to approximatively 5 years
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Secondary outcome [3]
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OR of PR or better per IMWG response criteria as determined by the IRC in all participants
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Assessment method [3]
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Timepoint [3]
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Up to approximatively 5 years
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Secondary outcome [4]
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OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
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Assessment method [4]
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Timepoint [4]
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Up to approximatively 5 years
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Secondary outcome [5]
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OR of VGPR or better per IMWG response criteria as determined by IRC in all participants
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Assessment method [5]
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0
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Timepoint [5]
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Up to approximatively 5 years
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Secondary outcome [6]
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OR of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants
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Assessment method [6]
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Timepoint [6]
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Up to approximatively 5 years
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Secondary outcome [7]
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OR of CR or better per IMWG response criteria as determined by IRC in all participants
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Assessment method [7]
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Timepoint [7]
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Up to approximatively 5 years
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Secondary outcome [8]
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Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies
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Assessment method [8]
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Timepoint [8]
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Up to approximatively 5 years
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Secondary outcome [9]
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Incidence of MRD negative status in all participants
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Assessment method [9]
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Timepoint [9]
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Up to approximatively 5 years
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Secondary outcome [10]
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Overall Survival (OS) in participants previously exposed to CD38 antibodies
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Assessment method [10]
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Timepoint [10]
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Up to approximatively 5 years
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Secondary outcome [11]
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OS in all participants
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Assessment method [11]
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Timepoint [11]
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Up to approximatively 5 years
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Secondary outcome [12]
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Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies
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Assessment method [12]
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The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
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Timepoint [12]
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Baseline to week 12
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Secondary outcome [13]
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Mean change in the worst pain score measured by BPI-SF Item 3 in all participants
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Assessment method [13]
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0
The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
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Timepoint [13]
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Baseline to week 12
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Secondary outcome [14]
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Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies
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Assessment method [14]
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Timepoint [14]
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Up to approximatively 5 years
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Secondary outcome [15]
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Incidence TEAEs in all participants
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Assessment method [15]
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Timepoint [15]
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Up to approximatively 5 years
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Secondary outcome [16]
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Severity of TEAEs in participants previously exposed to CD38 antibodies
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Assessment method [16]
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Timepoint [16]
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Up to approximatively 5 years
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Secondary outcome [17]
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Severity of TEAEs in all participants
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Assessment method [17]
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0
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Timepoint [17]
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Up to approximatively 5 years
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Secondary outcome [18]
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Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies
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Assessment method [18]
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0
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Timepoint [18]
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Up to approximatively 5 years
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Secondary outcome [19]
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Incidence of AESI in all participants
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Assessment method [19]
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0
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Timepoint [19]
0
0
Up to approximatively 5 years
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Secondary outcome [20]
0
0
Severity of AESI in participants previously exposed to CD38 antibodies
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Assessment method [20]
0
0
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Timepoint [20]
0
0
Up to approximatively 5 years
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Secondary outcome [21]
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Severity AESI in all participants
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Assessment method [21]
0
0
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Timepoint [21]
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Up to approximatively 5 years
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Secondary outcome [22]
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Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies
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Assessment method [22]
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0
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Timepoint [22]
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Up to approximatively 5 years
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Secondary outcome [23]
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0
Incidence of SAE in all participants
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Assessment method [23]
0
0
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Timepoint [23]
0
0
Up to approximatively 5 years
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Secondary outcome [24]
0
0
Severity of SAE in participants previously exposed to CD38 antibodies
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Assessment method [24]
0
0
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Timepoint [24]
0
0
Up to approximatively 5 years
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Secondary outcome [25]
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0
Severity of SAE in all participants
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Assessment method [25]
0
0
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Timepoint [25]
0
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Up to approximatively 5 years
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Secondary outcome [26]
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0
PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [26]
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0
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Timepoint [26]
0
0
Up to approximatively 5 years
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Secondary outcome [27]
0
0
PFS per IMWG response criteria as determined by the investigator in all participants
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Assessment method [27]
0
0
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Timepoint [27]
0
0
Up to approximatively 5 years
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Secondary outcome [28]
0
0
OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [28]
0
0
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Timepoint [28]
0
0
Up to approximatively 5 years
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Secondary outcome [29]
0
0
OR of PR or better per IMWG response criteria as determined by the investigator in all participants
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Assessment method [29]
0
0
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Timepoint [29]
0
0
Up to approximatively 5 years
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Secondary outcome [30]
0
0
OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [30]
0
0
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Timepoint [30]
0
0
Up to approximatively 5 years
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Secondary outcome [31]
0
0
OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants
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Assessment method [31]
0
0
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Timepoint [31]
0
0
Up to approximatively 5 years
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Secondary outcome [32]
0
0
OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [32]
0
0
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Timepoint [32]
0
0
Up to approximatively 5 years
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Secondary outcome [33]
0
0
OR of CR or better per IMWG response criteria as determined by the investigator in all participants
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Assessment method [33]
0
0
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Timepoint [33]
0
0
Up to approximatively 5 years
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Secondary outcome [34]
0
0
Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [34]
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0
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Timepoint [34]
0
0
Up to approximatively 5 years
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Secondary outcome [35]
0
0
DoR as per IMWG response criteria as determined by the investigator in all participants
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Assessment method [35]
0
0
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Timepoint [35]
0
0
Up to approximatively 5 years
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Secondary outcome [36]
0
0
DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
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Assessment method [36]
0
0
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Timepoint [36]
0
0
Up to approximatively 5 years
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Secondary outcome [37]
0
0
DoR as per IMWG response criteria as determined by the IRC in all participants
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Assessment method [37]
0
0
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Timepoint [37]
0
0
Up to approximatively 5 years
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Secondary outcome [38]
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Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies
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Assessment method [38]
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0
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Timepoint [38]
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0
Up to approximatively 5 years
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Secondary outcome [39]
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Duration of MRD negative status in the bone marrow in all participants
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Assessment method [39]
0
0
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Timepoint [39]
0
0
Up to approximatively 5 years
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Secondary outcome [40]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies
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Assessment method [40]
0
0
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Timepoint [40]
0
0
Up to approximatively 5 years
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Secondary outcome [41]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the investigator in all participants
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Assessment method [41]
0
0
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Timepoint [41]
0
0
Up to approximatively 5 years
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Secondary outcome [42]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies
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Assessment method [42]
0
0
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Timepoint [42]
0
0
Up to approximatively 5 years
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Secondary outcome [43]
0
0
Time from randomization to objective response (=PR) as per IMWG response criteria as determined by the IRC in all participants
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Assessment method [43]
0
0
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Timepoint [43]
0
0
Up to approximatively 5 years
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Secondary outcome [44]
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Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies
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Assessment method [44]
0
0
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Timepoint [44]
0
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Up to approximatively 5 years
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Secondary outcome [45]
0
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Concentration of linvoseltamab in the serum over time in all participants
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Assessment method [45]
0
0
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Timepoint [45]
0
0
Up to approximatively 5 years
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Secondary outcome [46]
0
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Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies
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Assessment method [46]
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0
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Timepoint [46]
0
0
Up to approximatively 5 years
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Secondary outcome [47]
0
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Incidence of ADAs in all participants
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Assessment method [47]
0
0
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Timepoint [47]
0
0
Up to approximatively 5 years
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Secondary outcome [48]
0
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Titer of ADAs in participants previously exposed to CD38 antibodies
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Assessment method [48]
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0
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Timepoint [48]
0
0
Up to approximatively 5 years
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Secondary outcome [49]
0
0
Titer of ADAs in all participants
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Assessment method [49]
0
0
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Timepoint [49]
0
0
Up to approximatively 5 years
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Secondary outcome [50]
0
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Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies
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Assessment method [50]
0
0
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Timepoint [50]
0
0
Up to approximatively 5 years
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Secondary outcome [51]
0
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Incidence of Nabs to linvoseltamab over time in all participants
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Assessment method [51]
0
0
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Timepoint [51]
0
0
Up to approximatively 5 years
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Secondary outcome [52]
0
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Proportion of Pain Responders in participants previously exposed to CD38 antibodies
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Assessment method [52]
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Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
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Timepoint [52]
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0
At week 12
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Secondary outcome [53]
0
0
Proportion of Pain Responders in all participants
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Assessment method [53]
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0
Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
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Timepoint [53]
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0
At week 12
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Secondary outcome [54]
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Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies
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Assessment method [54]
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The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
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Timepoint [54]
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Baseline to week 12
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Secondary outcome [55]
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Change in patient-reported QoL, per EORTC QLQ-C30 in all participants
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Assessment method [55]
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0
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
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Timepoint [55]
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Baseline to week 12
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Secondary outcome [56]
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Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies
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Assessment method [56]
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The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
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Timepoint [56]
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0
Baseline to week 12
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Secondary outcome [57]
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0
Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants
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Assessment method [57]
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0
The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
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Timepoint [57]
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0
Baseline to week 12
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Secondary outcome [58]
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0
Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies
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Assessment method [58]
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The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
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Timepoint [58]
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0
Baseline to week 12
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Secondary outcome [59]
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0
Patient-Reported Outcomes in PGIS in all participants
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Assessment method [59]
0
0
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
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Timepoint [59]
0
0
Baseline to week 12
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Secondary outcome [60]
0
0
Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies
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Assessment method [60]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
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Timepoint [60]
0
0
Baseline to week 12
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Secondary outcome [61]
0
0
Patient-Reported Outcomes in PGIC in all participants
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Assessment method [61]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.
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Timepoint [61]
0
0
Baseline to week 12
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Secondary outcome [62]
0
0
Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies
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Assessment method [62]
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0
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
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Timepoint [62]
0
0
Baseline to week 12
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Secondary outcome [63]
0
0
Change in patient-reported general health status per EQ-5D-5L in all participants
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Assessment method [63]
0
0
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
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Timepoint [63]
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0
Baseline to week 12
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Eligibility
Key inclusion criteria
Key
1. Age 18 years or older (or legal adult age in the country) at the time of the screening
visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status =1. Patients with ECOG 2
solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion
with the Medical Monitor.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies,
including lenalidomide and a proteasome inhibitor and demonstrated disease progression
on or after the last therapy as defined by the 2016 IMWG criteria. Participants who
have received only 1 line of prior line of antimyeloma therapy must 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.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG
response assessment criteria, as described in the protocol
5. Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of
adequate bone marrow reserves
6. Life expectancy of at least 6 months
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days
before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem
cell transplantation 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 acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note:
BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML,
or history of a neurocognitive condition or central nervous system (CNS) movement
disorder.
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2
weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the
protocol.
NOTE: Other protocol defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/12/2032
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Actual
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Sample size
Target
380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [3]
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Royal Brisbane Hospital - Herston
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Recruitment hospital [4]
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Integrated Clinical Oncology Network - South Brisbane
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Recruitment hospital [5]
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University Hospital Geelong - Geelong
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Recruitment hospital [6]
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Austin Hospital - Heidelberg
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Recruitment hospital [7]
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St Vincents Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3065 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Kentucky
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Washington
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Brazil
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State/province [7]
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Bahia
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Brazil
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Rio Grade Do Sul
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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São Paulo
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Canada
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Ontario
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France
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Gironde
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France
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Paris
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France
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Lille
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Israel
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Hamerkaz
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Italy
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Foggia
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Italy
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Forli Cesena
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Italy
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Lombardy
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Italy
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Ancona
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Italy
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Bologna
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Italy
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Pavia
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Italy
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Ravenna
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Italy
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Reggio Emilia
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Italy
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Torino
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Italy
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Turin
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Country [30]
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Korea, Republic of
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Busan
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Korea, Republic of
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State/province [31]
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Hwasun
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Korea, Republic of
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Incheon
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Korea, Republic of
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State/province [33]
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Jeonju
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Korea, Republic of
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Seoul
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Netherlands
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Gelderland
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Netherlands
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Zuid-Holland
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Poland
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Pomorskie
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Poland
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Katowice
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Singapore
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Kent Ridge
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Singapore
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Singapore
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Spain
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Asturias
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Spain
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Baleares
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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State/province [45]
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Islas Baleares
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Alicante
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Spain
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Girona
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Spain
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State/province [52]
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Zaragoza
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Country [53]
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Taiwan
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State/province [53]
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Changhua County
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Country [54]
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Taiwan
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State/province [54]
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Hualien City
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Country [55]
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Taiwan
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State/province [55]
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Kaohsiung
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Country [56]
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Taiwan
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State/province [56]
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Taipei
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Country [57]
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Taiwan
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State/province [57]
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Taoyuan
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Country [58]
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United Kingdom
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State/province [58]
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Surrey
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Country [59]
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United Kingdom
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State/province [59]
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Cambridge
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Country [60]
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United Kingdom
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State/province [60]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05730036
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trial Management
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Address
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Regeneron Pharmaceuticals
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Country
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Phone
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Fax
0
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Email
0
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Contact person for public queries
Name
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Clinical Trials Administrator
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Address
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Country
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Phone
0
0
844-734-6643
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Fax
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Email
0
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05730036
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