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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04484623
Registration number
NCT04484623
Ethics application status
Date submitted
21/07/2020
Date registered
23/07/2020
Date last updated
25/03/2025
Titles & IDs
Public title
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
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Scientific title
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
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Secondary ID [1]
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2018-004354-21
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Secondary ID [2]
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207499
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Universal Trial Number (UTN)
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Trial acronym
DREAMM 8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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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 - Belantamab mafodotin
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Experimental: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone -
Active comparator: Arm B: Bortezomib plus Pomalidomide and Dexamethasone -
Treatment: Drugs: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
Treatment: Drugs: Pomalidomide
Immunomodulatory drug (IMiD) will be administered.
Treatment: Drugs: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity will be administered.
Treatment: Drugs: Bortezomib
Proteasome Inhibitor will be administered.
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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 time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
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Timepoint [1]
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Up to approximately 174 weeks
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause.
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Timepoint [1]
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Up to approximately 473 weeks
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Secondary outcome [2]
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Duration of Response (DoR)
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Assessment method [2]
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Duration of Response (DoR) defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
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Timepoint [2]
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Up to approximately 473 weeks
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Secondary outcome [3]
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Minimal Residual Disease (MRD) Negativity Rate
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Assessment method [3]
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MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing at 10\^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG.
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Timepoint [3]
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Up to approximately 473 weeks
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Secondary outcome [4]
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Overall Response Rate (ORR)
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Assessment method [4]
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ORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
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Timepoint [4]
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Up to approximately 473 weeks
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Secondary outcome [5]
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Complete Response Rate (CRR)
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Assessment method [5]
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Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria.
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Timepoint [5]
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Up to approximately 473 weeks
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Secondary outcome [6]
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Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better
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Assessment method [6]
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VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
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Timepoint [6]
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Up to approximately 473 weeks
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Secondary outcome [7]
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Time to Best Response (TTBR)
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Assessment method [7]
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TTBR defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG.
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Timepoint [7]
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Up to approximately 473 weeks
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Secondary outcome [8]
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Time to Response (TTR)
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Assessment method [8]
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TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG.
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Timepoint [8]
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Up to approximately 473 weeks
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Secondary outcome [9]
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Time to Progression (TTP)
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Assessment method [9]
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TTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD.
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Timepoint [9]
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Up to approximately 473 weeks
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Secondary outcome [10]
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Progression-Free Survival 2 (PFS2)
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Assessment method [10]
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PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier.
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Timepoint [10]
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Up to approximately 473 weeks
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Secondary outcome [11]
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Number of Participants With Adverse Events (AEs)
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Assessment method [11]
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Timepoint [11]
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Up to approximately 473 weeks
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Secondary outcome [12]
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Number of Participants With Clinically Significant Changes in Hematology Parameters
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Assessment method [12]
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Blood samples will be collected for the analysis of hematology parameters.
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Timepoint [12]
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Up to approximately 473 weeks
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Secondary outcome [13]
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Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
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Assessment method [13]
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Blood samples will be collected for the analysis of clinical chemistry parameters.
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Timepoint [13]
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Up to approximately 473 weeks
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Secondary outcome [14]
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Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
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Assessment method [14]
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Timepoint [14]
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Up to approximately 473 weeks
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Secondary outcome [15]
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Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
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Assessment method [15]
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Blood samples will be collected for PK analysis of belantamab mafodotin.
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Timepoint [15]
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Up to approximately 473 weeks
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Secondary outcome [16]
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Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
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Assessment method [16]
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Blood samples will be collected for PK analysis of belantamab mafodotin.
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Timepoint [16]
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Up to approximately 473 weeks
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Secondary outcome [17]
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Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide
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Assessment method [17]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [17]
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Up to approximately 473 weeks
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Secondary outcome [18]
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Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide
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Assessment method [18]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [18]
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Up to approximately 473 weeks
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Secondary outcome [19]
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Maximum Concentration (Cmax) for Pomalidomide
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Assessment method [19]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [19]
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Up to approximately 473 weeks
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Secondary outcome [20]
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Time of Cmax (Tmax) for Pomalidomide
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Assessment method [20]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [20]
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Up to approximately 473 weeks
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Secondary outcome [21]
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Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide
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Assessment method [21]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [21]
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Up to approximately 473 weeks
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Secondary outcome [22]
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Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide
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Assessment method [22]
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Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.
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Timepoint [22]
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Up to approximately 473 weeks
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Secondary outcome [23]
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Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
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Assessment method [23]
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Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.
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Timepoint [23]
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Up to approximately 473 weeks
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Secondary outcome [24]
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Titers of ADAs Against Belantamab Mafodotin
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Assessment method [24]
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Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further characterized for antibody titers.
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Timepoint [24]
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Up to approximately 473 weeks
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Secondary outcome [25]
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Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [25]
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The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
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Timepoint [25]
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Up to approximately 473 weeks
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Secondary outcome [26]
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Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
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Assessment method [26]
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The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.
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Timepoint [26]
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Up to approximately 473 weeks
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Secondary outcome [27]
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Change From Baseline in Quality of Life Questionnaire 20-item Multiple Myeloma Module (QLQMY20)
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Assessment method [27]
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The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
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Timepoint [27]
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Up to approximately 473 weeks
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Secondary outcome [28]
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Change From Baseline in HRQoL as Measured by EORTC IL52
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Assessment method [28]
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The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning.
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Timepoint [28]
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Up to approximately 473 weeks
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Eligibility
Key inclusion criteria
* Capable of giving signed informed consent.
* Male or female, 18 years or older.
* Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide =10 mg daily for at least 2 consecutive cycles are eligible).
* Must have at least 1 aspect of measurable disease defined as one of the following;
1. Urine M-protein excretion greater than or equal to (=)200 milligrams (mg) per 24-hour, or
2. Serum M-protein concentration =0.5 grams/deciliters (g/dL) (=5.0 g/liter [L]), or
3. Serum free light chain (FLC) assay: involved FLC level =10 mg/dL (=100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
* Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
* All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (=)Grade 1 at the time of enrolment, except for alopecia.
* Adequate organ system functions as mentioned in the protocol.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
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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
* Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
* Prior allogeneic SCT.
* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
* Plasmapheresis within 7 days prior to the first dose of study drug.
* Received prior treatment with or intolerant to pomalidomide.
* Received prior Beta cell maturation antigen (BCMA) targeted therapy.
* Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).
* Evidence of cardiovascular risk including any of the following;
1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
2. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
4. Uncontrolled hypertension.
* Any major surgery within the last 4 weeks.
* Previous or concurrent invasive malignancy other than multiple myeloma, except:
1. The disease must be considered medically stable for at least 2 years; or
2. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Evidence of active mucosal or internal bleeding.
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
* Active infection requiring treatment.
* Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
* Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
* Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or =Grade 3 peripheral neuropathy.
* Active or history of venous and arterial thromboembolism within the past 3 months.
* Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
* Current corneal disease except for mild punctate keratopathy.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
* Pregnant or lactating female.
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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
Active, not 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
1/10/2020
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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
25/10/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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Recruitment hospital [2]
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GSK Investigational Site - Darlinghurst
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Recruitment hospital [3]
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0
GSK Investigational Site - Gosford NSW
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Recruitment hospital [4]
0
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GSK Investigational Site - Port Macquarie
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Recruitment hospital [5]
0
0
GSK Investigational Site - Benowa
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Recruitment hospital [6]
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GSK Investigational Site - South Brisbane
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Recruitment hospital [7]
0
0
GSK Investigational Site - Adelaide
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Recruitment hospital [8]
0
0
GSK Investigational Site - Fitzroy
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Recruitment hospital [9]
0
0
GSK Investigational Site - Heidelberg
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Recruitment hospital [10]
0
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GSK Investigational Site - Malvern
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Recruitment hospital [11]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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0
2605 - Garran
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2250 - Gosford NSW
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Recruitment postcode(s) [4]
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0
2444 - Port Macquarie
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Recruitment postcode(s) [5]
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0
4217 - Benowa
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Recruitment postcode(s) [6]
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0
4101 - South Brisbane
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Recruitment postcode(s) [7]
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0
5000 - Adelaide
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Recruitment postcode(s) [8]
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0
3065 - Fitzroy
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Recruitment postcode(s) [9]
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0
3084 - Heidelberg
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Recruitment postcode(s) [10]
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0
3144 - Malvern
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Recruitment postcode(s) [11]
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0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
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0
United States of America
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State/province [2]
0
0
Florida
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0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Tennessee
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Country [6]
0
0
Brazil
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State/province [6]
0
0
Curitiba
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Country [7]
0
0
Brazil
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State/province [7]
0
0
Joinville
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Country [8]
0
0
Brazil
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State/province [8]
0
0
Porto Alegre
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Country [9]
0
0
Brazil
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State/province [9]
0
0
SAo Paulo
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Country [10]
0
0
China
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State/province [10]
0
0
Beijing
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Country [11]
0
0
China
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State/province [11]
0
0
Changchun
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Country [12]
0
0
China
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State/province [12]
0
0
Changsha
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Country [13]
0
0
China
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State/province [13]
0
0
Hangzhou
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Country [14]
0
0
China
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State/province [14]
0
0
Jiangsu
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Country [15]
0
0
China
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State/province [15]
0
0
Nanchang
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Country [16]
0
0
China
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State/province [16]
0
0
Shenyang
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Country [17]
0
0
China
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State/province [17]
0
0
Tianjin
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Country [18]
0
0
Czechia
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State/province [18]
0
0
Brno
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Country [19]
0
0
Czechia
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State/province [19]
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Hradec Kralove
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Country [20]
0
0
Czechia
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State/province [20]
0
0
Praha 2
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Country [21]
0
0
France
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State/province [21]
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0
Marseille
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Country [22]
0
0
France
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State/province [22]
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0
Toulouse cedex 9
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Country [23]
0
0
France
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State/province [23]
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0
Vanduvre-lEs-Nancy
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Country [24]
0
0
Germany
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State/province [24]
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0
Mainz
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Country [25]
0
0
Germany
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State/province [25]
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0
Tuebingen
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Country [26]
0
0
Germany
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State/province [26]
0
0
Wuerzburg
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Country [27]
0
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Thessaloniki
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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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Kfar Saba
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Israel
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Nahariya
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Israel
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Petach-Tikva
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Israel
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Tel Aviv
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Italy
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Bologna
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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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Roma
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Japan
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Japan
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Japan
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Gunma
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Japan
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Japan
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Iwate
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tottori
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Japan
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Yamagata
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Hwasun
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Korea, Republic of
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Inchon
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Seoul
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Auckland
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Dunedin
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New Zealand
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Grafton
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New Zealand
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Hamilton
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New Zealand
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Takapuna Auckland
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New Zealand
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Tauranga
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Poland
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Poland
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Lodz
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Poland
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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Sochi
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Russian Federation
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St Petersburg
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Russian Federation
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St-Petersburg
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Barcelona
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Gijon
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Spain
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L'Hospitalet De Llobrega
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Spain
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Madrid
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Spain
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MOstoles Madrid
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Spain
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Murcia
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Spain
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Spain
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Pozuelo De AlarcOn Madr
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Ankara
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Turkey
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Turkey
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Kocaeli
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Turkey
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Mersin
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Turkey
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Samsun
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United Kingdom
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London
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Stoke on Trent
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
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Trial website
https://clinicaltrials.gov/study/NCT04484623
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Public notes
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Contacts
Principal investigator
Name
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0
GSK Clinical Trials
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Address
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0
GlaxoSmithKline
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Contact person for public queries
Name
0
0
US GSK Clinical Trials Call Center
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Address
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Phone
0
0
877-379-3718
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Email
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0
[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
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/23/NCT04484623/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/23/NCT04484623/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04484623
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