COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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/show/NCT04162210




Registration number
NCT04162210
Ethics application status
Date submitted
11/11/2019
Date registered
14/11/2019
Date last updated
16/09/2020

Titles & IDs
Public title
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Scientific title
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
Secondary ID [1] 0 0
207495
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Pom/dex (Pomalidomide plus low dose Dexamethasone)

Experimental: Participants receiving Belantamab mafodotin - Participants will receive belantamab mafodotin single agent dose of 2.5 mg/kg on Day 1 of Q3W

Active Comparator: Participants receiving pom/dex - Participants will receive pomalidomide orally starting dose of 4 mg daily on Days 1 to 21 of each 28-cycle, with dexamethasone at an oral dose of 40 mg once weekly or a lower dose of 20 mg once weekly on Days 1, 8, 15 and 22.


Treatment: Drugs: Belantamab mafodotin
Belantamab mafodotin will be available as powder for solution for infusion which will be administered via intravenous (IV) route. Belantamab mafodotin will be reconstituted for injection 100 mg/vial with 2.0 milliliter (mL) of water for injection with dose level of 2.5 mg/kg.

Treatment: Drugs: Pom/dex (Pomalidomide plus low dose Dexamethasone)
Pomalidomide will available as capsule and Dexamethasone will be available as tablet which will be administered via oral route.

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

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) - PFS, defined as the time from the date of randomization until the earliest date of documented disease progression (according to International Myeloma Working Group [IMWG] Response Criteria) or death due to any cause
Timepoint [1] 0 0
Up to 20 months
Secondary outcome [1] 0 0
Overall survival (OS) - OS, defined as the time from randomization until death due to any cause
Timepoint [1] 0 0
Up to 55 months
Secondary outcome [2] 0 0
Overall response rate (ORR) - ORR, defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG
Timepoint [2] 0 0
Up to 55 months
Secondary outcome [3] 0 0
Clinical benefit rate (CBR) - CBR defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG
Timepoint [3] 0 0
Up to 55 months
Secondary outcome [4] 0 0
Duration of response (DoR) - DoR, defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better
Timepoint [4] 0 0
Up to 55 months
Secondary outcome [5] 0 0
Time to response (TTR) - TTR, defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.
Timepoint [5] 0 0
Up to 55 months
Secondary outcome [6] 0 0
Time to progression (TTP) - TTP, defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD
Timepoint [6] 0 0
Up to 55 months
Secondary outcome [7] 0 0
Number of participants with adverse events (AEs) - An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Timepoint [7] 0 0
Up to 55 months
Secondary outcome [8] 0 0
Change from Baseline in hematology parameters: absolute white blood cell count (WBC), basophils,eosinophils, lymphocytes, monocytes, platelet count, and neutrophils (Giga cells per liter) - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [8] 0 0
Baseline and up to 55 months
Secondary outcome [9] 0 0
Change from Baseline in hematology parameters: Red Blood Cell (RBC) count and reticulocyte count (Trillion cells per liter) - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [9] 0 0
Baseline and up to 55 months
Secondary outcome [10] 0 0
Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin concentration (MCHC) and hemoglobin (Grams per Liter) - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [10] 0 0
Baseline and up to 55 months
Secondary outcome [11] 0 0
Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood) - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [11] 0 0
Baseline and up to 55 months
Secondary outcome [12] 0 0
Change from Baseline in hematology parameters: Mean Corpuscular Volume (MCV) [Femtoliter] - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [12] 0 0
Baseline and up to 55 months
Secondary outcome [13] 0 0
Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms] - Blood samples will be collected at indicated time-points for the analysis of hematology parameters
Timepoint [13] 0 0
Baseline and up to 55 months
Secondary outcome [14] 0 0
Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine kinase (CK), Gamma Glutamyl Transferase (GGT), and lactate dehydrogenase (LDH) - Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH [International units per Liter]
Timepoint [14] 0 0
Baseline and up to 55 months
Secondary outcome [15] 0 0
Change from Baseline in clinical chemistry parameters: Calcium, chloride, glucose, potassium, sodium, magnesium, blood urea nitrogen (BUN), and phosphorous (Millimoles per Liter) - Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters
Timepoint [15] 0 0
Baseline and up to 55 months
Secondary outcome [16] 0 0
Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (Micromoles per liter) - Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters
Timepoint [16] 0 0
Baseline and up to 55 months
Secondary outcome [17] 0 0
Change from Baseline in clinical chemistry parameters: Albumin and total protein (Grams per Liter) - Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters
Timepoint [17] 0 0
Baseline and up to 55 months
Secondary outcome [18] 0 0
Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio) - Urine samples will be collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.
Timepoint [18] 0 0
Baseline and up to 55 months
Secondary outcome [19] 0 0
Change from Baseline in Urinalysis Parameters- Urine potential of hydrogen (pH) (Points on a scale) - Urine samples will be collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Timepoint [19] 0 0
Baseline and up to 55 months
Secondary outcome [20] 0 0
Change from Baseline in urinalysis parameter: Glucose (Millimole per liter) - Urine samples will be collected at indicated time points for the assessment of urinary glucose.
Timepoint [20] 0 0
Baseline and up to 55 months
Secondary outcome [21] 0 0
Change from Baseline in urinalysis parameter: Protein (Grams per liter) - Urine samples will be collected at indicated time points for the assessment of urinary protein.
Timepoint [21] 0 0
Baseline and up to 55 months
Secondary outcome [22] 0 0
Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter) - Urine samples will be collected at indicated time points for the assessment of urinary ketones.
Timepoint [22] 0 0
Baseline and up to 55 months
Secondary outcome [23] 0 0
Change from Baseline in urinalysis parameter: blood (10^9 cells per liter) - Urine samples will be collected at indicated time points for the assessment of urinary blood.
Timepoint [23] 0 0
Baseline and up to 55 months
Secondary outcome [24] 0 0
Change from Baseline in urinalysis parameter: creatinine/albumin ratio (ratio) - Urine samples will be collected at indicated time points for the assessment of urinary creatinine/albumin ratio.
Timepoint [24] 0 0
Baseline and up to 55 months
Secondary outcome [25] 0 0
Number of participants with abnormal ocular findings - Participants will be assessed for any abnormal ocular findings
Timepoint [25] 0 0
Up to 55 months
Secondary outcome [26] 0 0
Plasma concentrations of belantamab mafodotin - Blood samples will be collected at indicated time points for the analysis
Timepoint [26] 0 0
Up to 55 months
Secondary outcome [27] 0 0
Plasma concentrations of total monoclonal antibody (mAb) - Blood samples will be collected at indicated time points for the analysis
Timepoint [27] 0 0
Up to 55 months
Secondary outcome [28] 0 0
Plasma concentrations of cys-mc Microtubular inhibitor monomethyl auristatin-F (MMAF) - Blood samples will be collected at indicated time points for the analysis
Timepoint [28] 0 0
Up to 55 months
Secondary outcome [29] 0 0
Number of participants with Anti-drug antibody (ADAs) against belantamab mafodotin - Blood samples will be collected at indicated time points for the analysis
Timepoint [29] 0 0
Up to 55 months
Secondary outcome [30] 0 0
Titer of ADAs against belantamab mafodotin - Blood samples will be collected at indicated time points for the analysis
Timepoint [30] 0 0
Up to 55 months
Secondary outcome [31] 0 0
Number of participants with symptomatic adverse effects measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Timepoint [31] 0 0
Up to 55 months
Secondary outcome [32] 0 0
Number of participants with symptomatic adverse effects measured by Ocular Surface Disease Index (OSDI) - OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning
Timepoint [32] 0 0
Up to 55 months
Secondary outcome [33] 0 0
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQC30) score - The EORTC QLQ-C30 is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/quality of life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure are averaged and transformed linearly to a score ranging from 0-100.
Timepoint [33] 0 0
Up to 55 months
Secondary outcome [34] 0 0
European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) score - The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. Disease Symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. QLQ-C30, QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms represents a high level of symptomatology or problems
Timepoint [34] 0 0
Up to 55 months
Secondary outcome [35] 0 0
Rate of Minimal Residual Disease (MRD) - MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method
Timepoint [35] 0 0
Up to 55 months

Eligibility
Key inclusion criteria
- Capable of giving signed informed consent.

- Participants must be 18 or older, at the time of signing the informed consent. In
Republic of Korea, participants must be over 19 years of age inclusive, at the time of
signing informed consent.

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

- Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as
defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT),
or is considered transplant ineligible; Has received at least 2 prior lines of
anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide
and a proteasome inhibitor (given separately or in combination), and must have
documented disease progression on, or within 60 days of, completion of the last
treatment as defined by IMWG.

- Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram
per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum
free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (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: Transplant was >100 days prior to
initiating study treatment; No active infection(s).

- Adequate organ system functions as defined: Absolute neutrophil count (ANC)
>=1.0*10^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x10^9/L; Total bilirubin <=1.5*
Upper limit of normal (ULN) (isolated bilirubin >1.5*ULN is acceptable if bilirubin is
fractionated and direct bilirubin <35 percent); ALT <=2.5*ULN; Estimated glomerular
filtration rate (eGFR) >=30 milliliter per minute per 1.73 square meter (mL/min/1.73
m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56
milligram per millimoles [mg/mmol]); Left ventricular ejection fraction (LVEF)
(echocardiogram) Clinically asymptomatic participants with ECHO confirmed LVEF>=25
percent

- 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 until 5 months after the last dose of study intervention
to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, 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 depending on whether they are
randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have
undergone a successful vasectomy: Agree to use a male condom throughout study
treatment including the 5 month* follow-up period even if they have undergone a
successful vasectomy and a female partner to use an additional highly effective
contraceptive method with a failure rate of <1 percent per year when having sexual
intercourse with a pregnant woman or a woman of childbearing potential who is not
currently pregnant. * Four weeks for male participants on Treatment Arm 2 (pom/dex).

- 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
childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm
1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a
failure rate of <1 percent per year) which includes abstinence, preferably with low
user dependency during the intervention period and for 8 months after the last dose of
study treatment. Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue
with risk for embryofetal 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 pomalidomide, during therapy,
during dose interruptions and continuing for at least 4 weeks following
discontinuation of pomalidomide treatment. Two negative pregnancy tests must be
obtained prior to initiating therapy. The first test should be performed within 10-14
days and the second test within 24 hours prior to prescribing pomalidomide therapy.
And agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during
this period. The investigator should confirm the effectiveness of the contraceptive
method(s) ahead of the first dose of study intervention.

- All prior treatment-related toxicities (defined by National Cancer Institute- Common
Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1
at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.

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

- Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5
half-lives, whichever is shorter, before the first dose of study intervention.

- Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving
the first dose of study intervention.

- Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide
treatment.

- Plasmapheresis within 7 days prior to the first dose of study intervention.

- Prior allogeneic stem cell transplant.

- Any major surgery within the last 4 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 fulfil 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 with study procedures.

- History of (non-infectious) pneumonitis that required steroids, or current
pneumonitis.

- Evidence of active mucosal or internal bleeding.

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

- Participants with previous or concurrent 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.

- Evidence of cardiovascular risk including any of the following: QT interval corrected
for heart rate by Fridericia's formula (QTcF) >= 480 millisecond (msec); Evidence of
current clinically significant uncontrolled arrhythmias including clinically
significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type
II) or 3rd degree atrioventricular 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 (NYHA) functional classification system;
Uncontrolled hypertension.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the
components of the study intervention.

- Pregnant or lactating female.

- Active infection requiring treatment.

- Known human immunodeficiency virus (HIV).

- 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 intervention.

- 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
intervention.

- Participants unable to tolerate thromboembolic prophylaxis.

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 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [2] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [3] 0 0
GSK Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Belgium
State/province [12] 0 0
Kortrijk
Country [13] 0 0
Belgium
State/province [13] 0 0
Yvoir
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
France
State/province [17] 0 0
Poitiers cedex
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Haidari, Athens
Country [20] 0 0
Greece
State/province [20] 0 0
Larisa
Country [21] 0 0
Greece
State/province [21] 0 0
Patra
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloniki
Country [23] 0 0
Italy
State/province [23] 0 0
Calabria
Country [24] 0 0
Italy
State/province [24] 0 0
Puglia
Country [25] 0 0
Japan
State/province [25] 0 0
Ehime
Country [26] 0 0
Japan
State/province [26] 0 0
Fukushima
Country [27] 0 0
Japan
State/province [27] 0 0
Gifu
Country [28] 0 0
Japan
State/province [28] 0 0
Gunma
Country [29] 0 0
Japan
State/province [29] 0 0
Kyoto
Country [30] 0 0
Japan
State/province [30] 0 0
Saitama
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seongnam-si, Gyeonggi-do
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Netherlands
State/province [34] 0 0
Amersfoort
Country [35] 0 0
Spain
State/province [35] 0 0
Pamplona
Country [36] 0 0
Spain
State/province [36] 0 0
Salamanca
Country [37] 0 0
Spain
State/province [37] 0 0
Santiago de Compostela
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Dundee
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, randomized study for evaluating the efficacy and safety of single agent
belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be
randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex.
Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg)/kilogram (kg)
on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at
the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with
dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22).
Participants in both arms will be treated until disease progression, death, unacceptable
toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes
first. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional
country requirements).
Trial website
https://clinicaltrials.gov/show/NCT04162210
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
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04162210