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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03525678




Registration number
NCT03525678
Ethics application status
Date submitted
3/05/2018
Date registered
16/05/2018
Date last updated
8/07/2020

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Scientific title
A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)
Secondary ID [1] 0 0
2017-004810-25
Secondary ID [2] 0 0
205678
Universal Trial Number (UTN)
Trial acronym
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 - GSK2857916 frozen liquid
Treatment: Drugs - GSK2857916 lyophilized powder

Experimental: Participants receiving frozen 2.5 mg/kg GSK2857916 - Participants will receive 2.5 mg/kg frozen liquid of GSK2857916. Participants will be administered with frozen liquid of GSK2857916 via infusion pump every 3 weeks.

Experimental: Participants receiving frozen 3.4 mg/kg GSK2857916 - Participants will receive 3.4 mg/kg frozen liquid GSK2857916. Participants will be administered with frozen liquid of GSK2857916 via infusion pump every 3 weeks.

Experimental: Participants receiving lyophilized GSK2857916 - Participants in lyophilized arm will receive lyophilized GSK2857916 once lyophilized configuration becomes available and enrollment has been completed for frozen liquid arms.


Treatment: Drugs: GSK2857916 frozen liquid
GSK2857916 will be available as frozen liquid. Frozen liquid will be available as 30 milligram (mg)/vial solution in a single use vial with unit dose strength of 2.5 or 3.4 mg/kg. GSK2857916 will be administered as IV solution over at least 30 minutes. Frozen GSK2857916 will be diluted 0.9 percent saline and administered via infusion pump.

Treatment: Drugs: GSK2857916 lyophilized powder
GSK2857916 will be available as lyophilized powder. Lyophilized powder will be available as 100 mg/vial in single-use vial for reconstitution with unit dose strength of 2.5 or 3.4 mg/kg. Lyophilized GSK2857916 will reconstituted using water for injection, dilute with saline before use.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) - ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is [i.e.], PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]). Confidence intervals were based on the exact method.
Timepoint [1] 0 0
Up to 48 weeks
Primary outcome [2] 0 0
Overall Response Rate by Independent Review Committee (Efficacy Population) - ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population) - ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [2] 0 0
Overall Response Rate by Investigator Assessment (Efficacy Population) - ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population) - CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [3] 0 0
Up to 48 weeks
Secondary outcome [4] 0 0
Clinical Benefit Rate by Investigator Assessment (Efficacy Population) - CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [4] 0 0
Up to 48 weeks
Secondary outcome [5] 0 0
Clinical Benefit Rate by Independent Review Committee (Full Analysis Population) - CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [5] 0 0
Up to 48 weeks
Secondary outcome [6] 0 0
Clinical Benefit Rate by Independent Review Committee (Efficacy Population) - CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Timepoint [6] 0 0
Up to 48 weeks
Secondary outcome [7] 0 0
Duration of Response (DoR) by Investigator Assessment (Full Analysis Population) - DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Timepoint [7] 0 0
Up to 48 weeks
Secondary outcome [8] 0 0
Duration of Response by Investigator Assessment (Efficacy Population) - DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Timepoint [8] 0 0
Up to 48 weeks
Secondary outcome [9] 0 0
Duration of Response by Independent Review Committee (Full Analysis Population) - DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Timepoint [9] 0 0
Up to 48 weeks
Secondary outcome [10] 0 0
Duration of Response by Independent Review Committee (Efficacy Population) - DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Timepoint [10] 0 0
Up to 48 weeks
Secondary outcome [11] 0 0
Time to Response by Investigator Assessment (Full Analysis Population) - Time to response is 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). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Timepoint [11] 0 0
Up to 48 weeks
Secondary outcome [12] 0 0
Time to Response by Investigator Assessment (Efficacy Population) - Time to response is 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). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Timepoint [12] 0 0
Up to 48 weeks
Secondary outcome [13] 0 0
Time to Response by Independent Review Committee (Full Analysis Population) - Time to response is 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). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Timepoint [13] 0 0
Up to 48 weeks
Secondary outcome [14] 0 0
Time to Response by Independent Review Committee (Efficacy Population) - Time to response is 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). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Timepoint [14] 0 0
Up to 48 weeks
Secondary outcome [15] 0 0
Progression Free Survival by Investigator Assessment - Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Timepoint [15] 0 0
Up to 48 weeks
Secondary outcome [16] 0 0
Progression Free Survival by Independent Review Committee - Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Timepoint [16] 0 0
Up to 48 weeks
Secondary outcome [17] 0 0
Time to Progression by Investigator Assessment - Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Timepoint [17] 0 0
Up to 48 weeks
Secondary outcome [18] 0 0
Time to Progression by Independent Review Committee - Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Timepoint [18] 0 0
Up to 48 weeks
Secondary outcome [19] 0 0
Overall Survival - Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Timepoint [19] 0 0
Up to 48 weeks
Secondary outcome [20] 0 0
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range - Following parameters were assessed:basophils(Baso),eosinophils(Eosino),hematocrit(Hct),mean corpuscular hemoglobin(MCH),MCH concentration(MCHC),MC volume(MCV),monocyte(Mono),erythrocytes(Erythro),reticulocytes(Reticu).Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range[LNR]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [20] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [21] 0 0
Number of Participants With Grade Change From Baseline in Hematology Parameters - Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.
Timepoint [21] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [22] 0 0
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range - Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein, urea or blood urea nitrogen(BUN),estimated glomerular filtration rate (eGFR).Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Timepoint [22] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [23] 0 0
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters - Blood samples were collected for analysis of clinical chemistry parameters: glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil), creatinine kinase (CK), creatinine, gamma glutamyl transferase (GGT), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences. Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented. Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Timepoint [23] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [24] 0 0
Number of Participants With Abnormal Findings During Physical Examination - Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.
Timepoint [24] 0 0
Up to 48 weeks
Secondary outcome [25] 0 0
Number of Participants With Change From Baseline in Pulse Rate - Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to <60 beats per minute [bpm]', 'increase to >100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <60 bpm' and 'increased to >100 bpm' during post Baseline. Data for worst-case post Baseline is presented.
Timepoint [25] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [26] 0 0
Number of Participants With Change From Baseline in Body Temperature - Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to <=35 degrees celsius', 'increase to >=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to >=38 to increase to >=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <=35' and 'increased to >=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.
Timepoint [26] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [27] 0 0
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) - SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: <120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented.
Timepoint [27] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [28] 0 0
Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI) - An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and common (>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.
Timepoint [28] 0 0
Up to 48 weeks
Secondary outcome [29] 0 0
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline <0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from Baseline >=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [29] 0 0
Baseline (Day 1) and Up to 48 weeks
Secondary outcome [30] 0 0
Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP >=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [30] 0 0
Up to 48 weeks
Secondary outcome [31] 0 0
Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented.
Timepoint [31] 0 0
Baseline and Up to 48 weeks
Secondary outcome [32] 0 0
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline) - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [32] 0 0
Baseline and Up to 48 weeks
Secondary outcome [33] 0 0
Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS) - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [33] 0 0
Baseline and Up to 48 weeks
Secondary outcome [34] 0 0
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [34] 0 0
Baseline and Up to 48 weeks
Secondary outcome [35] 0 0
Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline) - Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from >10 seconds (Baseline) to <=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Timepoint [35] 0 0
Baseline and Up to 48 weeks
Secondary outcome [36] 0 0
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment.
Timepoint [36] 0 0
Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [37] 0 0
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Timepoint [37] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [38] 0 0
Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Timepoint [38] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [39] 0 0
Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Timepoint [39] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [40] 0 0
Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Timepoint [40] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [41] 0 0
Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Timepoint [41] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [42] 0 0
AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [42] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [43] 0 0
AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [43] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [44] 0 0
AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [44] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [45] 0 0
Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [45] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [46] 0 0
Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [46] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [47] 0 0
t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Timepoint [47] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [48] 0 0
AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [48] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [49] 0 0
AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [49] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [50] 0 0
AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [50] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [51] 0 0
Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [51] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [52] 0 0
Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [52] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [53] 0 0
t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM - Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Timepoint [53] 0 0
Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Secondary outcome [54] 0 0
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result - Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Timepoint [54] 0 0
Up to 48 weeks
Secondary outcome [55] 0 0
Titers of Anti-drug Antibodies Against GSK2857916 - Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arms; GSK2857916 3.4 mg/kg (Frozen liquid) and GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values are not presented for both these arms.
Timepoint [55] 0 0
Up to 48 weeks
Secondary outcome [56] 0 0
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision (BV), chills, constipation, decreased appetite (DA), fatigue, general pain (GP), heart palpitations (HP), mouth/throat (M/T) sores, nausea, nosebleed, shortness of breath (SB), vomiting and watery eyes (WE). Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.
Timepoint [56] 0 0
Up to 48 weeks
Secondary outcome [57] 0 0
Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score - The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Timepoint [57] 0 0
Baseline (Day 1) and up to Week 48
Secondary outcome [58] 0 0
Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score - The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Timepoint [58] 0 0
Baseline (Day 1) and up to Week 48
Secondary outcome [59] 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 - The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 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, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Timepoint [59] 0 0
Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37 and Week 43
Secondary outcome [60] 0 0
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score - The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Timepoint [60] 0 0
Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37 and Week 43

Eligibility
Key inclusion criteria
- Participants who provided signed written informed consent, which includes compliance
with the requirements and restrictions listed in the consent form.

- Male or female, 18 years or older.

- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Participants with histologically or cytologically confirmed diagnosis of MM as defined
in IMWG, 2014 criteria, and participant has undergone stem cell transplant or is
considered transplant ineligible and has failed at least 3 prior lines of anti-myeloma
treatments, including an anti-CD38 antibody (example [e.g.], daratumumab) alone or in
combination, and is refractory to an Immunomodulatory drugs (IMiD) (that is [i.e.],
lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib,
ixazomib or carfilzomib).

- The participant has measurable disease with at least one of the following: Serum
M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per Liter [g/L]); Urine
M-protein >=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay:
Involved FLC level >=10 mg/dL (>=100 mg/Liter) and an abnormal serum FLC ratio (<0.26
or >1.65).

- Participants with a history of autologous stem cell transplant are eligible for study
participation provided the following eligibility criteria are met: transplant was >100
days prior to study enrollment; no active infection(s); participants meet the
remainder of the eligibility criteria outlined in this protocol.

- Participants with adequate organ system functions as defined follows: Absolute
neutrophil count (ANC) >=1.0 X 10^9/L; Hemoglobin >=8.0 g/dL; Platelets>= 50 X 10^9/L;
Total bilirubin <=1.5X Upper limit of normal (ULN). Isolated bilirubin >=1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin <35 percent); Alanine
aminotransferase (ALT) <=2.5X ULN; Estimated glomerular filtration rate (eGFR) >=30
milliliter per minute per 1.73 meter square (mL/min/m^2); Spot urine
(albumin/creatinine ratios [spot urine]) <500 milligram per gram (mg/g) (56 mg per
millimoles [mg/mmol]); Left ventricular ejection fraction (LVEF) >=45 percent.

- Female participants: Contraceptive use by men or women should be consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies. A female participant is eligible to participate if she is not pregnant or
breastfeeding, and not a woman of childbearing 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 80 days after the last dose of study intervention and agrees not to donate eggs
(ova, oocytes) for the purpose of reproduction during this period. The investigator
should evaluate the effectiveness of the contraceptive method in relationship to the
first dose of study intervention. A WOCBP must have a negative highly sensitive serum
pregnancy test (as required by local regulations) within 72 hours before the first
dose of study intervention. 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.

- Male participants: Contraceptive use by men or women 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
during the intervention period and for at least 140 days: Refrain from donating sperm;
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
Agree to use a male condom and female partner to use an additional highly effective
contraceptive method with a failure rate of <1% per year as when having sexual
intercourse with a WOCBP who is not currently pregnant.

- All prior treatment-related toxicities (defined by National Cancer Institute- Common
Toxicity Criteria for Adverse Events [NCI-CTCAE]), version 4.03, must be <=Grade 1 at
the time of enrollment except for alopecia and Grade 2 peripheral neuropathy.

- For France only: A participant will be eligible for inclusion in this study only if
either affiliated to or a beneficiary of a social security category.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systemic anti-myeloma therapy within <=14 days, or 5 half-lives, whichever is shorter,
or plasmapheresis within 7 days prior to the first dose of study drug.

- Systemic treatment with high dose steroids (equivalent to >=60 mg prednisone daily for
>=4 days) within the past 14 days if administered to treat MM or non-MM disease.

- Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma
protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time
of screening.

- Prior allogeneic stem cell transplant.

- Current corneal epithelial disease except mild punctate keratopathy.

- Use of an investigational drug within 14 days or five half-lives, whichever is
shorter, 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 BCMA
targeted therapy.

- 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.

- 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 unstable liver or biliary disease per investigator assessment defined by the
presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or
gastric varices, persistent jaundice, or cirrhosis.

- Malignancies other than disease under study are excluded, except for any other
malignancy from which the participant has been disease-free for more than 2 years and,
in the opinion of the principal investigators and GlaxoSmithKline Medical Monitor,
will not affect the evaluation of the effects of this clinical trial treatment on the
currently targeted malignancy (MM). Participants with curatively treated non-melanoma
skin cancer may be enrolled.

- Evidence of cardiovascular risk including any of the following: Corrected QT interval
Fridericia (QTcF) interval >480 milliseconds (msec); Evidence of current clinically
significant uncontrolled arrhythmias, including clinically significant
electrocardiogram abnormalities such as 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 six months of Screening; Class III or IV heart failure as defined by
the New York Heart Association functional classification system (NYHA); Uncontrolled
hypertension.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to GSK2857916, or any of the components of the study treatment.

- Pregnant or lactating female.

- Active infection requiring antibiotic, antiviral, or antifungal 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [2] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
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
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
France
State/province [22] 0 0
Lille Cedex
Country [23] 0 0
France
State/province [23] 0 0
Nantes cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Pessac
Country [26] 0 0
France
State/province [26] 0 0
Pierre-Bénite cedex
Country [27] 0 0
France
State/province [27] 0 0
Toulouse cedex 9
Country [28] 0 0
Germany
State/province [28] 0 0
Baden-Wuerttemberg
Country [29] 0 0
Germany
State/province [29] 0 0
Bayern
Country [30] 0 0
Germany
State/province [30] 0 0
Mecklenburg-Vorpommern
Country [31] 0 0
Germany
State/province [31] 0 0
Niedersachsen
Country [32] 0 0
Germany
State/province [32] 0 0
Rheinland-Pfalz
Country [33] 0 0
Germany
State/province [33] 0 0
Sachsen
Country [34] 0 0
Italy
State/province [34] 0 0
Basilicata
Country [35] 0 0
Italy
State/province [35] 0 0
Emilia-Romagna
Country [36] 0 0
Italy
State/province [36] 0 0
Friuli-Venezia-Giulia
Country [37] 0 0
Italy
State/province [37] 0 0
Piemonte
Country [38] 0 0
Spain
State/province [38] 0 0
Badalona
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Granada
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Murcia
Country [43] 0 0
Spain
State/province [43] 0 0
Pamplona
Country [44] 0 0
Spain
State/province [44] 0 0
Pozuelo De Alarcón/Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Salamanca
Country [46] 0 0
Spain
State/province [46] 0 0
Valencia
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Staffordshire
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Surrey
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Birmingham
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Bournemouth
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Headington, Oxford
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all
cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory
multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety
of GSK2857916 monotherapy. Participants will be treated with GSK2857916 monotherapy until
disease progression (PD) or unacceptable toxicity and will be followed for Progression Free
Survival and Overall survival. The participants will be randomized to receive either frozen
GSK2857916 at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg Intravenous (IV).
There will be an independent cohort of participants who will receive a lyophilized
configuration of GSK2857916. The participants who discontinued from the study other than
Progressive disease (PD), disease evaluation will continue to be performed at 3-week
intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of
consent, or end of the study whichever occurs first.
Trial website
https://clinicaltrials.gov/show/NCT03525678
Trial related presentations / publications
Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortüm KM, Rodríguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.
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

Summary results
Other publications