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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03544281




Registration number
NCT03544281
Ethics application status
Date submitted
30/04/2018
Date registered
1/06/2018

Titles & IDs
Public title
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Scientific title
A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6
Secondary ID [1] 0 0
2017-004689-93
Secondary ID [2] 0 0
207497
Universal Trial Number (UTN)
Trial acronym
DREAMM 6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib

Experimental: Arm A: Belantamab mafodotin+lenalidomide +dexamethasone - Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion.

SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle.

STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \& 22 of each cycle.

Experimental: Arm B: Belantamab mafodotin+bortezomib+dexamethasone - Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \& so on). Bortezomib will be administered at 1.3 mg/m\^2 SC/IV on Days 1,4,8, \& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \& 12 of every 21-day cycle.


Treatment: Drugs: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as an infusion.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.

Treatment: Drugs: Bortezomib
Bortezomib will be administered as 1.3 mg/m\^2, as SC or IV, with belantamab mafodotin and dexamethasone.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of Participants With DLTs, Treatment B
Timepoint [2] 0 0
Up to 21 days
Primary outcome [3] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to approximately 4.5 years
Primary outcome [4] 0 0
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Timepoint [4] 0 0
Up to approximately 4.5 years
Primary outcome [5] 0 0
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Timepoint [5] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [6] 0 0
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Timepoint [6] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [7] 0 0
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Timepoint [7] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [8] 0 0
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Timepoint [8] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [9] 0 0
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
Timepoint [9] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [10] 0 0
Change From Baseline in Urine Potential of Hydrogen (pH)
Timepoint [10] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [11] 0 0
Change From Baseline in Urine Specific Gravity
Timepoint [11] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [12] 0 0
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Timepoint [12] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [13] 0 0
Change From Baseline in Vital Signs : Pulse Rate
Timepoint [13] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [14] 0 0
Change From Baseline in Vital Signs : Temperature
Timepoint [14] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Primary outcome [15] 0 0
Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
Timepoint [15] 0 0
Up to approximately 4.5 years
Secondary outcome [1] 0 0
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
Timepoint [1] 0 0
Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [2] 0 0
Area Under the Concentration Time Curve (AUC) From Time 0 to 504 Hours (0-504h) for Belantamab Mafodotin ADC, Treatment A
Timepoint [2] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
Secondary outcome [3] 0 0
AUC (0-672h) for Belantamab Mafodotin ADC, Treatment A
Timepoint [3] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
Secondary outcome [4] 0 0
Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A
Timepoint [4] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [5] 0 0
Time of Last Observed Quantifiable Concentration (Tlast) for Belantamab Mafodotin ADC, Treatment A
Timepoint [5] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28
Secondary outcome [6] 0 0
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
Timepoint [6] 0 0
Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
Secondary outcome [7] 0 0
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
Timepoint [7] 0 0
Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
Secondary outcome [8] 0 0
Cmax for Belantamab Mafodotin ADC, Treatment B
Timepoint [8] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [9] 0 0
AUC (0-504h) for Belantamab Mafodotin ADC, Treatment B
Timepoint [9] 0 0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
Secondary outcome [10] 0 0
AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B
Timepoint [10] 0 0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7
Secondary outcome [11] 0 0
Tmax for Belantamab Mafodotin ADC, Treatment B
Timepoint [11] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [12] 0 0
Tlast for Belantamab Mafodotin ADC, Treatment B
Timepoint [12] 0 0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1
Secondary outcome [13] 0 0
Ctrough for Belantamab Mafodotin ADC, Treatment B
Timepoint [13] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
Secondary outcome [14] 0 0
C-EOI for Belantamab Mafodotin ADC, Treatment B
Timepoint [14] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8
Secondary outcome [15] 0 0
Cmax for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [15] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [16] 0 0
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [16] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
Secondary outcome [17] 0 0
AUC (0-672h) for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [17] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
Secondary outcome [18] 0 0
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [18] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7
Secondary outcome [19] 0 0
AUC(0-1344h) for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [19] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7
Secondary outcome [20] 0 0
Tmax for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [20] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [21] 0 0
Tlast for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [21] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8
Secondary outcome [22] 0 0
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [22] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Secondary outcome [23] 0 0
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
Timepoint [23] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Secondary outcome [24] 0 0
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
Timepoint [24] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [25] 0 0
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [25] 0 0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
Secondary outcome [26] 0 0
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [26] 0 0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7
Secondary outcome [27] 0 0
Tmax for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [27] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [28] 0 0
Tlast for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [28] 0 0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1
Secondary outcome [29] 0 0
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [29] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
Secondary outcome [30] 0 0
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
Timepoint [30] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
Secondary outcome [31] 0 0
Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A
Timepoint [31] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [32] 0 0
AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Timepoint [32] 0 0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, and Cycle 1 Day 8
Secondary outcome [33] 0 0
AUC (0-336h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Timepoint [33] 0 0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14
Secondary outcome [34] 0 0
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Timepoint [34] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [35] 0 0
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Timepoint [35] 0 0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15
Secondary outcome [36] 0 0
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Timepoint [36] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Secondary outcome [37] 0 0
Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B
Timepoint [37] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [38] 0 0
AUC(0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Timepoint [38] 0 0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7
Secondary outcome [39] 0 0
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Timepoint [39] 0 0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Secondary outcome [40] 0 0
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Timepoint [40] 0 0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1
Secondary outcome [41] 0 0
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Timepoint [41] 0 0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8
Secondary outcome [42] 0 0
Cmax for Lenalidomide (25 mg), Treatment A
Timepoint [42] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [43] 0 0
AUC(0-24h) for Lenalidomide (25 mg), Treatment A
Timepoint [43] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [44] 0 0
AUC (0-4h) for Lenalidomide (25 mg), Treatment A
Timepoint [44] 0 0
Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [45] 0 0
Tmax for Lenalidomide (25 mg), Treatment A
Timepoint [45] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [46] 0 0
Tlast for Lenalidomide (25 mg), Treatment A
Timepoint [46] 0 0
Pre-Dose, Post dose on Cycle 1 Day 1
Secondary outcome [47] 0 0
Cmax for Lenalidomide (10 mg), Treatment A
Timepoint [47] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [48] 0 0
AUC(0-24h) for Lenalidomide (10 mg), Treatment A
Timepoint [48] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [49] 0 0
AUC (0-4h) for Lenalidomide (10 mg), Treatment A
Timepoint [49] 0 0
Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [50] 0 0
Tmax for Lenalidomide (10 mg), Treatment A
Timepoint [50] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Secondary outcome [51] 0 0
Tlast for Lenalidomide (10 mg), Treatment A
Timepoint [51] 0 0
Pre-Dose, Post dose on Cycle 1 Day 1
Secondary outcome [52] 0 0
Cmax for Bortezomib, Treatment B
Timepoint [52] 0 0
Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1
Secondary outcome [53] 0 0
AUC (0-72h) for Bortezomib, Treatment B
Timepoint [53] 0 0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Secondary outcome [54] 0 0
AUC (0-t) for Bortezomib, Treatment B
Timepoint [54] 0 0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Secondary outcome [55] 0 0
Tmax for Bortezomib, Treatment B
Timepoint [55] 0 0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Secondary outcome [56] 0 0
Tlast for Bortezomib, Treatment B
Timepoint [56] 0 0
Pre-Dose, Post dose on Cycle 1 Day 3
Secondary outcome [57] 0 0
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Timepoint [57] 0 0
Up to approximately 4.5 years (End of Treatment [EoT])
Secondary outcome [58] 0 0
Titers of ADAs Against Belantamab Mafodotin
Timepoint [58] 0 0
Up to approximately 4.5 years
Secondary outcome [59] 0 0
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
Timepoint [59] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [60] 0 0
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
Timepoint [60] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [61] 0 0
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [61] 0 0
Up to approximately 4.5 years
Secondary outcome [62] 0 0
Number of Participants With AEs of Special Interest (AESI)
Timepoint [62] 0 0
Up to approximately 4.5 years
Secondary outcome [63] 0 0
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Timepoint [63] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [64] 0 0
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Timepoint [64] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [65] 0 0
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Timepoint [65] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [66] 0 0
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Timepoint [66] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [67] 0 0
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Timepoint [67] 0 0
Baseline (Day 1) and up to approximately 4.5 years
Secondary outcome [68] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Timepoint [68] 0 0
Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])
Secondary outcome [69] 0 0
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Timepoint [69] 0 0
Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent.
* Male or female, 18 years or older (at the time consent is obtained).
* Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
* Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
* Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy.
* Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
* Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
* All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
* Adequate organ system functions as defined by the laboratory assessments.
* The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

WOCBP Participants Assigned to Arm A:

* Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy.

WOCBP Participants Assigned to Arm B

* WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer.
* Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants are eligible to participate if they agree to the following:

Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm.

Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm.

* Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below.
* Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
* Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
* Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
* Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD).
* Evidence of active mucosal or internal bleeding.
* Any major surgery within the last four weeks.
* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
* Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
* Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
* Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Pregnant or lactating female.
* Active infection requiring treatment.
* Known Human immunodeficiency virus (HIV) infection.
* Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
* Current corneal disease except for mild punctuate keratopathy.
* Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
* Current corneal disease except for mild punctute keratopathy.
* Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
* Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/02/2024
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [2] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [3] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [6] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Spain
State/province [15] 0 0
Salamanca
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cornwall
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03544281