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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06208150
Registration number
NCT06208150
Ethics application status
Date submitted
5/01/2024
Date registered
17/01/2024
Titles & IDs
Public title
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
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Scientific title
A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
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Secondary ID [1]
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0
64407564MMY3009
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Secondary ID [2]
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64407564MMY3009
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Universal Trial Number (UTN)
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Trial acronym
MonumenTAL-6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or 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 - Talquetamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Teclistamab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P) - Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec) - Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Active comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd) - Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Treatment: Drugs: Talquetamab
Talquetamab will be administered as a SC injection.
Treatment: Drugs: Pomalidomide
Pomalidomide will be administered orally.
Treatment: Drugs: Teclistamab
Teclistamab will be administered as a SC injection.
Treatment: Drugs: Elotuzumab
Elotuzumab will be administered intravenously.
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered either orally or intravenously.
Treatment: Drugs: Bortezomib
Bortezomib will be administered as a SC injection.
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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)
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Assessment method [1]
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PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.
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Timepoint [1]
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Up to 6 years 5 months
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.
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Timepoint [1]
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Up to 6 years 5 months
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Secondary outcome [2]
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Complete Response (CR) or Better Rate
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Assessment method [2]
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CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.
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Timepoint [2]
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Up to 6 years 5 months
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Secondary outcome [3]
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Very Good Partial Response (VGPR) or Better Rate
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Assessment method [3]
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VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.
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Timepoint [3]
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Up to 6 years 5 months
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Secondary outcome [4]
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Minimal Residual Disease (MRD)-negative CR Rate
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Assessment method [4]
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MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10\^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).
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Timepoint [4]
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Up to 6 years 5 months
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as the time from randomization to the date of participant's death.
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Timepoint [5]
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Up to 6 years 5 months
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Secondary outcome [6]
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Progression Free Survival on Next-line Therapy (PFS2)
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Assessment method [6]
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PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.
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Timepoint [6]
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Up to 6 years 5 months
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Secondary outcome [7]
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Time to Next Treatment (TTNT)
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Assessment method [7]
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TTNT is defined as the time from randomization to the start of SST.
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Timepoint [7]
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Up to 6 years 5 months
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Secondary outcome [8]
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Serum Concentration of Talquetamab and Teclistamab
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Assessment method [8]
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Serum concentration of talquetamab and teclistamab will be reported.
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Timepoint [8]
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Up to 6 years 5 months
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Secondary outcome [9]
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Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
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Assessment method [9]
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Number of participants with ADAs to talquetamab and teclistamab will be reported.
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Timepoint [9]
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Up to 6 years 5 months
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Secondary outcome [10]
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
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Assessment method [10]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.
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Timepoint [10]
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Up to 6 years 5 months
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Secondary outcome [11]
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
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Assessment method [11]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level.
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Timepoint [11]
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Up to 6 years 5 months
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Secondary outcome [12]
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
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Assessment method [12]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [12]
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Up to 6 years 5 months
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Secondary outcome [13]
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
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Assessment method [13]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."
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Timepoint [13]
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Up to 6 years 5 months
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Secondary outcome [14]
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
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Assessment method [14]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.
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Timepoint [14]
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Up to 6 years 5 months
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Secondary outcome [15]
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
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Assessment method [15]
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Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.
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Timepoint [15]
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Up to 6 years 5 months
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Secondary outcome [16]
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
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Assessment method [16]
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Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.
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Timepoint [16]
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Up to 6 years 5 months
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Secondary outcome [17]
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
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Assessment method [17]
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Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [17]
0
0
Up to 6 years 5 months
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Secondary outcome [18]
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
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Assessment method [18]
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Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."
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Timepoint [18]
0
0
Up to 6 years 5 months
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Secondary outcome [19]
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
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Assessment method [19]
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Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.
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Timepoint [19]
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Up to 6 years 5 months
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Secondary outcome [20]
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Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
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Assessment method [20]
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Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.
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Timepoint [20]
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Up to 6 years 5 months
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Eligibility
Key inclusion criteria
* Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
* Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
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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
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
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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
22/01/2024
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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
30/06/2030
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Actual
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Sample size
Target
795
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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St Vincents Hospital - Darlinghurst
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Recruitment hospital [4]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [5]
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Gold Coast University Hospital - Southport
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Recruitment hospital [6]
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Perth Blood Institute - West Perth
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Recruitment hospital [7]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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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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4215 - Southport
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Recruitment postcode(s) [6]
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6005 - West Perth
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Recruitment postcode(s) [7]
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2500 - Wollongong
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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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Connecticut
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Kentucky
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Michigan
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Minnesota
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Austria
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Salzburg
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Belgium
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Charleroi
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Sint-Niklaas
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Brazil
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Belo Horizonte
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Brazil
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Brasilia
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Brazil
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Caxias do Sul
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio de Janeiro
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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China
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Beijing
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China
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Changzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Jinan
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China
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Nanchang
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China
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Shanghai
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China
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Shenyang
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China
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Shenzhen
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China
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Tianjin
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China
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Wenzhou
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China
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Wuhan
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China
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Xi'an
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Czechia
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Brno - Bohunice
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava
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Denmark
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Aarhus
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Denmark
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Odense C
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Denmark
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Vejle
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France
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Lille
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France
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Limoges
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Pessac Cedex
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France
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Pierre-Benite
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France
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Strasbourg
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France
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Toulouse Cedex 9
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France
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TOURS Cedex 01
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Germany
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Augsburg
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Germany
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Halle (Saale)
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Germany
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Heidelberg
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Germany
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Magdeburg
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Germany
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München
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Germany
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Tuebingen
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Germany
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Würzburg
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Pecs
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India
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Gurgaon
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India
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Pune
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Israel
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Be'er Ya'akov
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Israel
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Haifa
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv-Yafo
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Italy
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Alessandria
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Italy
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Brindisi
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Italy
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Catania
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Italy
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Genova
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Italy
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Legnano
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Italy
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Milano
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Italy
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Pavia
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Italy
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Pescara
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Italy
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Ravenna
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Italy
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Torino
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Italy
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Verona
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Japan
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Bunkyo Ku
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Japan
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Fukuoka
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Japan
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Kanazawa
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Japan
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Kyoto
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Japan
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Nagasaki
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Japan
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Narita
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Japan
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Niigata
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Japan
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Nishinomiya-shi
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Japan
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Osaka
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Japan
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Sapporo
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Japan
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Shibuya-ku
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Japan
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Japan
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Suita-City
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Sunto-gun
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Japan
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Tokyo
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Japan
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Tottori
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Tsukuba
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Japan
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Yokohama City
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Busan
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Jeollanam-do
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Seoul
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Ulsan
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Netherlands
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Almere
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Den Haag
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Eindhoven
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Nieuwegein
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Zwolle
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Poland
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Biala Podlaska
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Poland
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Brzozow
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Kielce
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Lublin
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Szczecin
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Wroclaw
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Saudi Arabia
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Riyadh
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Asturias
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Barcelona
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Burgos
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Cáceres
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Granada
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Spain
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Lugo
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Spain
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Madrid
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Palma de Mallorca
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Pamplona
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San Sebastian
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Santander
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Santiago de Compostela
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Sweden
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Lund
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Sweden
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Uppsala
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Sweden
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Varberg
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Turkey
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Ankara
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Turkey
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Denizli
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Turkey
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Istanbul
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Turkey
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Samsun
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United Kingdom
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Cardiff
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United Kingdom
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Dundee
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United Kingdom
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Plymouth
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United Kingdom
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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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
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Query!
Trial website
https://clinicaltrials.gov/study/NCT06208150
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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0
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
0
Study Contact
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Address
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0
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Country
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0
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Phone
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0
844-434-4210
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Fax
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
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/NCT06208150