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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06669247
Registration number
NCT06669247
Ethics application status
Date submitted
30/10/2024
Date registered
1/11/2024
Date last updated
8/07/2025
Titles & IDs
Public title
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
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Scientific title
A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
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Secondary ID [1]
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2024-513126-39-00
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Secondary ID [2]
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R7945-ONC-22110
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Universal Trial Number (UTN)
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Trial acronym
COSTIMM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma
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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
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Description of intervention(s) / exposure
Treatment: Drugs - Linvoseltamab
Treatment: Drugs - REGN7945+Linvoseltamab
Experimental: REGN7945+Linvoseltamab - Phase 1 Phase 2
Experimental: Linvoseltamab - Phase 2
Treatment: Drugs: Linvoseltamab
Administered per protocol
Treatment: Drugs: REGN7945+Linvoseltamab
Administered per protocol
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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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Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab
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Assessment method [1]
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Phase 1
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Timepoint [1]
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Up to 21 days
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Primary outcome [2]
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Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab
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Assessment method [2]
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Phase 1
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Timepoint [2]
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Up to 5 years
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Primary outcome [3]
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Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab
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Assessment method [3]
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Phase 1
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Timepoint [3]
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Up to 5 years
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Primary outcome [4]
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Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination therapy
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Assessment method [4]
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Phase 2
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Timepoint [4]
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Within 12 weeks of starting cycle 1
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Primary outcome [5]
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VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
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Assessment method [5]
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Phase 2
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Timepoint [5]
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Within 12 weeks of starting cycle 1
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Primary outcome [6]
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Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy
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Assessment method [6]
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Phase 2
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Timepoint [6]
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Within 12 weeks of starting cycle 1
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Primary outcome [7]
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PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
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Assessment method [7]
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Phase 2
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Timepoint [7]
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Within 12 weeks of starting cycle 1
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Secondary outcome [1]
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Incidence of TEAEs
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Assessment method [1]
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Phase 1 and Phase 2
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Severity of TEAEs
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Assessment method [2]
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Phase 1 and Phase 2
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Concentrations of REGN7945 in the serum
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Assessment method [3]
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Phase 1 and Phase 2
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Concentrations of linvoseltamab in the serum
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Assessment method [4]
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Phase 1 and Phase 2
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Incidence of anti-drug antibodies (ADA) to REGN7945
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Assessment method [5]
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Phase 1 and Phase 2
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Titer of ADA to REGN7945
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Assessment method [6]
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Phase 1 and Phase 2
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Incidence of ADA to linvoseltamab
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Assessment method [7]
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Phase 1 and Phase 2
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Titer of ADA to linvoseltamab
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Assessment method [8]
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Phase 1 and Phase 2
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)
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Assessment method [9]
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Phase 1 and Phase 2 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 5 = "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 9 = "very much" higher scores indicate higher symptom burden.
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Change in EORTC QLQ-C30 Physical Functioning (PF)
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Assessment method [10]
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Phase 1 and Phase 2
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Change in EORTC QLQ-C30 Role Functioning (RF)
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Assessment method [11]
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Phase 1 and Phase 2
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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Change in EORTC QLQ-C30 pain
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Assessment method [12]
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Phase 1 and Phase 2
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Timepoint [12]
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Up to 5 years
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Secondary outcome [13]
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Change in EORTC QLQ-C30 fatigue
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Assessment method [13]
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Phase 1 and Phase 2
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Timepoint [13]
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Up to 5 years
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Secondary outcome [14]
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Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL
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Assessment method [14]
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Phase 1 and Phase 2
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Timepoint [14]
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Up to 5 years
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Secondary outcome [15]
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Time to definitive deterioration in EORTC QLQ-C30 PF
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Assessment method [15]
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Phase 1 and Phase 2
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Timepoint [15]
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Up to 5 years
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Secondary outcome [16]
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Time to definitive deterioration in EORTC QLQ-C30 RF
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Assessment method [16]
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Phase 1 and Phase 2
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Timepoint [16]
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Up to 5 years
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Secondary outcome [17]
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Time to definitive deterioration in EORTC QLQ-C30 pain
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Assessment method [17]
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Phase 1 and Phase 2
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Timepoint [17]
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Up to 5 years
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Secondary outcome [18]
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Time to definitive deterioration in EORTC QLQ-C30 fatigue
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Assessment method [18]
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Phase 1 and Phase 2
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Timepoint [18]
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Up to 5 years
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Secondary outcome [19]
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Time to first improvement in EORTC QLQ-C30 GHS/QoL
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Assessment method [19]
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Phase 1 and Phase 2
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Timepoint [19]
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Up to 5 years
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Secondary outcome [20]
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Time to first improvement in EORTC QLQ-C30 PF
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Assessment method [20]
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Phase 1 and Phase 2
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Timepoint [20]
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Up to 5 years
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Secondary outcome [21]
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Time to first improvement in EORTC QLQ-C30 RF
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Assessment method [21]
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Phase 1 and Phase 2
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Timepoint [21]
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Up to 5 years
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Secondary outcome [22]
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Time to first improvement in EORTC QLQ-C30 pain
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Assessment method [22]
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Phase 1 and Phase 2
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Timepoint [22]
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Up to 5 years
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Secondary outcome [23]
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Time to first improvement in EORTC QLQ-C30 fatigue
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Assessment method [23]
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Phase 1 and Phase 2
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Timepoint [23]
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Up to 5 years
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Secondary outcome [24]
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Change in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)
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Assessment method [24]
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Phase 1 and Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with Multiple Myeloma (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 [24]
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Up to 5 years
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Secondary outcome [25]
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Change in EORTC QLQ-MY20 Treatment Side Effects (TSE)
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Assessment method [25]
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Phase 1 and Phase 2
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Timepoint [25]
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Up to 5 years
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Secondary outcome [26]
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Change in EORTC QLQ-MY20 Body Image (BI)
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Assessment method [26]
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Phase 1 and Phase 2
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Timepoint [26]
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UP to 5 years
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Secondary outcome [27]
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Change in EORTC QLQ-MY20 Future Perspective (FP)
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Assessment method [27]
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Phase 1 and Phase 2
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Timepoint [27]
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Up to 5 years
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Secondary outcome [28]
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Time to definitive deterioration in EORTC QLQ-MY20 DS
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Assessment method [28]
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Phase 1 and Phase 2
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Timepoint [28]
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Up to 5 years
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Secondary outcome [29]
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Time to definitive deterioration in EORTC QLQ-MY20 TSE
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Assessment method [29]
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Phase 1 and Phase 2
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Timepoint [29]
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Up to 5 years
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Secondary outcome [30]
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Time to definitive deterioration in EORTC QLQ-MY20 BI
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Assessment method [30]
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Phase 1 and Phase 2
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Timepoint [30]
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Up to 5 years
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Secondary outcome [31]
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Time to definitive deterioration in EORTC QLQ-MY20 FP
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Assessment method [31]
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Phase 1 and Phase 2
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Timepoint [31]
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Up to 5 years
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Secondary outcome [32]
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Time to first improvement in EORTC QLQ-MY20 DS
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Assessment method [32]
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Phase 1 and Phase 2
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Timepoint [32]
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Up to 5 years
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Secondary outcome [33]
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Time to first improvement in EORTC QLQ-MY20 TSE
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Assessment method [33]
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Phase 1 and Phase 2
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Timepoint [33]
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Up to 5 years
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Secondary outcome [34]
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Time to first improvement in EORTC QLQ-MY20 BI
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Assessment method [34]
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Phase 1 and Phase 2
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Timepoint [34]
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Up to 5 years
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Secondary outcome [35]
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Time to first improvement in EORTC QLQ-MY20 FP
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Assessment method [35]
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Phase 1 and Phase 2
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Timepoint [35]
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Up to 5 years
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Secondary outcome [36]
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Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)
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Assessment method [36]
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Phase 1 and Phase 2 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 (no problems, slight problems, some problems, severe problems and extreme problems) and a visual analogue scale (VAS).
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Timepoint [36]
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Up to 5 years
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Secondary outcome [37]
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Time to definitive deterioration in EQ-5D-5L VAS
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Assessment method [37]
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Phase 1 and Phase 2
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Timepoint [37]
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Up to 5 years
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Secondary outcome [38]
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Time to first improvement in EQ-5D-5L VAS
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Assessment method [38]
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Phase 1 and Phase 2
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Timepoint [38]
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Up to 5 days
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Secondary outcome [39]
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Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT)-Item GP5
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Assessment method [39]
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Phase 1 and Phase 2 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).
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Timepoint [39]
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Up to 5 years
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Secondary outcome [40]
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Objective Response Rate (ORR) as measured by IMWG criteria as determined by the investigator
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Assessment method [40]
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Phase 1
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Timepoint [40]
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Up to 5 years
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Secondary outcome [41]
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Complete response (CR) rate as measured by IMWG criteria as determined by the investigator
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Assessment method [41]
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Phase 1
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Timepoint [41]
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Up to 5 years
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Secondary outcome [42]
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Duration of response (DOR) by IMWG criteria as determined by the investigator
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Assessment method [42]
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Phase 1
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Timepoint [42]
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Up to 5 years
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Secondary outcome [43]
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Progression Free Survival (PFS) as measured by IMWG criteria as determined by the investigator
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Assessment method [43]
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Phase 1
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Timepoint [43]
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Up to 5 years
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Secondary outcome [44]
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Achievement of Minimal Residual Disease (MRD) negative status (at 10^5) in participants in CR or better
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Assessment method [44]
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Phase 1
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Timepoint [44]
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Up to 5 years
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Secondary outcome [45]
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Overall survival (OS)
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Assessment method [45]
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Phase 1
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Timepoint [45]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
1. Eastern Cooperative Oncology Group (ECOG) performance status =1 as described in the protocol
2. Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) and have demonstrated disease progression on or after the last therapy, as defined in the protocol. Prior treatment with other BCMA directed immunotherapies, including BCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA x CD3 bispecific antibodies (Phase 1 only), is allowed
3. Participants must have the measurable disease for response assessment as described in the protocol
4. Adequate hematologic, hepatic, and renal function as described in the protocol
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, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
2. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
3. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment
4. Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent within 72 hours of start of study drug
5. Participants who have known central nervous system (CNS) involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), history of a neurocognitive condition or CNS disorder, or history of seizure within 12 months prior to study enrollment
6. Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential
7. Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
8. Myelodysplastic syndrome or another malignancy in the past 3 years, except for nonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stage prostate adenocarcinoma, as described in the protocol
9. Significant cardiovascular disease as described in the protocol
10. Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol
11. Known hypersensitivity to both allopurinol and rasburicase
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
Non-randomised 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 1
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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
11/12/2024
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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
1/11/2035
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Actual
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Sample size
Target
186
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Illawarra Cancer Care Centre - Wollongong
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Recruitment hospital [2]
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Pindara Private Hospital - Benowa
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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St Vincent's Hospital - Melbourne - Fitzroy
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Recruitment hospital [5]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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London
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Country [2]
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United Kingdom
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State/province [2]
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Manchester
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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 REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. 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 several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much * How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects) * If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)
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Trial website
https://clinicaltrials.gov/study/NCT06669247
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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
0
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Fax
0
0
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Email
0
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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0
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Phone
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844-734-6643
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06669247
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