Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03525678
Ethics application status
Date submitted
3/05/2018
Date registered
16/05/2018

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 - Belantamab mafodotin frozen liquid
Treatment: Drugs - Belantamab mafodotin lyophilized powder

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

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

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


Treatment: Drugs: Belantamab mafodotin frozen liquid
Belantamab mafodotin 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. Belantamab mafodotin will be administered as IV solution over at least 30 minutes. Frozen belantamab mafodotin will be diluted in 0.9 percent saline and administered via infusion pump.

Treatment: Drugs: Belantamab mafodotin lyophilized powder
Belantamab mafodotin 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 3.4 mg/kg. Lyophilized belantamab mafodotin will be reconstituted using water for injection and diluted 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)
Timepoint [1] 0 0
Up to 48 weeks
Primary outcome [2] 0 0
Overall Response Rate by Independent Review Committee (Efficacy Population)
Timepoint [2] 0 0
Up to 48 weeks
Secondary outcome [1] 0 0
Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)
Timepoint [1] 0 0
Up to 186 weeks
Secondary outcome [2] 0 0
Overall Response Rate by Investigator Assessment (Efficacy Population)
Timepoint [2] 0 0
Up to 186 weeks
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
Timepoint [3] 0 0
Up to 186 weeks
Secondary outcome [4] 0 0
Clinical Benefit Rate by Investigator Assessment (Efficacy Population)
Timepoint [4] 0 0
Up to 186 weeks
Secondary outcome [5] 0 0
Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)
Timepoint [5] 0 0
Up to 186 weeks
Secondary outcome [6] 0 0
Clinical Benefit Rate by Independent Review Committee (Efficacy Population)
Timepoint [6] 0 0
Up to 186 weeks
Secondary outcome [7] 0 0
Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
Timepoint [7] 0 0
Up to 186 weeks
Secondary outcome [8] 0 0
Duration of Response by Investigator Assessment (Efficacy Population)
Timepoint [8] 0 0
Up to 186 weeks
Secondary outcome [9] 0 0
Duration of Response by Independent Review Committee (Full Analysis Population)
Timepoint [9] 0 0
Up to 186 weeks
Secondary outcome [10] 0 0
Duration of Response by Independent Review Committee (Efficacy Population)
Timepoint [10] 0 0
Up to 186 weeks
Secondary outcome [11] 0 0
Time to Response by Investigator Assessment (Full Analysis Population)
Timepoint [11] 0 0
Up to 186 weeks
Secondary outcome [12] 0 0
Time to Response by Investigator Assessment (Efficacy Population)
Timepoint [12] 0 0
Up to 186 weeks
Secondary outcome [13] 0 0
Time to Response by Independent Review Committee (Full Analysis Population)
Timepoint [13] 0 0
Up to 186 weeks
Secondary outcome [14] 0 0
Time to Response by Independent Review Committee (Efficacy Population)
Timepoint [14] 0 0
Up to 186 weeks
Secondary outcome [15] 0 0
Progression Free Survival by Investigator Assessment
Timepoint [15] 0 0
Up to 186 weeks
Secondary outcome [16] 0 0
Progression Free Survival by Independent Review Committee
Timepoint [16] 0 0
Up to 186 weeks
Secondary outcome [17] 0 0
Time to Progression by Investigator Assessment
Timepoint [17] 0 0
Up to 186 weeks
Secondary outcome [18] 0 0
Time to Progression by Independent Review Committee
Timepoint [18] 0 0
Up to 186 weeks
Secondary outcome [19] 0 0
Overall Survival
Timepoint [19] 0 0
Up to 186 weeks
Secondary outcome [20] 0 0
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Timepoint [20] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [21] 0 0
Number of Participants With Grade Change From Baseline in Hematology Parameters
Timepoint [21] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [22] 0 0
Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range
Timepoint [22] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [23] 0 0
Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Timepoint [23] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [24] 0 0
Number of Participants With Abnormal Findings During Physical Examination
Timepoint [24] 0 0
Up to 186 weeks
Secondary outcome [25] 0 0
Number of Participants With Change From Baseline in Pulse Rate
Timepoint [25] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [26] 0 0
Number of Participants With Change From Baseline in Body Temperature
Timepoint [26] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [27] 0 0
Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [27] 0 0
Baseline (Day 1) and Up to 186 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)
Timepoint [28] 0 0
Up to 186 weeks
Secondary outcome [29] 0 0
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
Timepoint [29] 0 0
Baseline (Day 1) and Up to 186 weeks
Secondary outcome [30] 0 0
Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline
Timepoint [30] 0 0
Up to 186 weeks
Secondary outcome [31] 0 0
Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)
Timepoint [31] 0 0
Baseline and Up to 186 weeks
Secondary outcome [32] 0 0
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
Timepoint [32] 0 0
Baseline and Up to 186 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)
Timepoint [33] 0 0
Baseline and Up to 186 weeks
Secondary outcome [34] 0 0
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Timepoint [34] 0 0
Baseline and Up to 186 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)
Timepoint [35] 0 0
Baseline and Up to 186 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Timepoint [54] 0 0
Up to 186 weeks
Secondary outcome [55] 0 0
Titers of Anti-drug Antibodies Against GSK2857916
Timepoint [55] 0 0
Up to 186 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)
Timepoint [56] 0 0
Up to 186 weeks
Secondary outcome [57] 0 0
Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
Timepoint [57] 0 0
Baseline (Day 1) and up to Week 186
Secondary outcome [58] 0 0
Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Timepoint [58] 0 0
Baseline (Day 1) and up to Week 186
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
Timepoint [59] 0 0
Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186
Secondary outcome [60] 0 0
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Timepoint [60] 0 0
Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186

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 drug (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 the 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) (Echocardiogram)>=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
Sex
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 B-cell maturation antigen (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 belantamab mafodotin, 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
18/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [3] 0 0
GSK Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
5011 - Woodville
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
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Canada
State/province [18] 0 0
Calgary
Country [19] 0 0
Canada
State/province [19] 0 0
Toronto
Country [20] 0 0
Canada
State/province [20] 0 0
Winnipeg
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Nantes cedex 1
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pessac cedex
Country [25] 0 0
France
State/province [25] 0 0
Pierre BEnite
Country [26] 0 0
France
State/province [26] 0 0
Toulouse cedex 9
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Hannover
Country [29] 0 0
Germany
State/province [29] 0 0
Koblenz
Country [30] 0 0
Germany
State/province [30] 0 0
Schwerin
Country [31] 0 0
Germany
State/province [31] 0 0
Tuebingen
Country [32] 0 0
Germany
State/province [32] 0 0
Wuerzburg
Country [33] 0 0
Italy
State/province [33] 0 0
Aviano PN
Country [34] 0 0
Italy
State/province [34] 0 0
Parma
Country [35] 0 0
Italy
State/province [35] 0 0
Rionero In Vulture PZ
Country [36] 0 0
Italy
State/province [36] 0 0
Torino
Country [37] 0 0
Spain
State/province [37] 0 0
Badalona
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Granada
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Murcia
Country [42] 0 0
Spain
State/province [42] 0 0
PamplonaNavarra
Country [43] 0 0
Spain
State/province [43] 0 0
Salamanca
Country [44] 0 0
Spain
State/province [44] 0 0
Valencia
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Birmingham
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Bournemouth
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Nottingham
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Oxford
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Stoke on Trent
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Sutton

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

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 received 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/NCT03525678