Belantamab mafodotin: Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
Pomalidomide: Immunomodulatory drug (IMiD) will be administered.
Dexamethasone: Synthetic glucocorticoid with anti-tumor activity will be administered.
Bortezomib: Proteasome Inhibitor will be administered.
Study summary
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Capable of giving signed informed consent.
* Male or female, 18 years or older.
* Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
* Must have at least 1 aspect of measurable disease defined as one of the following;
1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter \[L\]), or
3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than \[\<\]0.26 or greater than \[\>\]1.65) only if participant has no measurable urine or serum M spike.
* Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was \>100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
* All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
* Adequate organ system functions as mentioned in the protocol.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
Exclusion Criteria:
* Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
* Prior allogeneic SCT.
* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
* Plasmapheresis within 7 days prior to the first dose of study drug.
* Received prior treatment with or intolerant to pomalidomide.
* Received prior Beta cell maturation antigen (BCMA) targeted therapy.
* Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square \[m\^2\] twice weekly).
* Evidence of cardiovascular risk including any of the following;
1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
2. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
4. Uncontrolled hypertension.
* Any major surgery within the last 4 weeks.
* Previous or concurrent invasive malignancy other than multiple myeloma, except:
1. The disease must be considered medically stable for at least 2 years; or
2. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Evidence of active mucosal or internal bleeding.
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
* Active infection requiring treatment.
* Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
* Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
* Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
* Active or history of venous and arterial thromboembolism within the past 3 months.
* Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
* Current corneal disease except for mild punctate keratopathy.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
* Pregnant or lactating female.
Primary outcome measure(s)
Progression-Free Survival (PFS) — Up to approximately 174 weeks PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Trial sites (122)
Facility
City
Region
Status
GSK Investigational Site
Tucson
Arizona
GSK Investigational Site
Fort Myers
Florida
GSK Investigational Site
Boston
Massachusetts
GSK Investigational Site
Kansas City
Missouri
GSK Investigational Site
Nashville
Tennessee
GSK Investigational Site
Garran
Australian Capital Territory
GSK Investigational Site
Darlinghurst
New South Wales
GSK Investigational Site
Gosford NSW
New South Wales
GSK Investigational Site
Port Macquarie
New South Wales
GSK Investigational Site
Benowa
Queensland
GSK Investigational Site
South Brisbane
Queensland
GSK Investigational Site
Adelaide
South Australia
GSK Investigational Site
Fitzroy
Victoria
GSK Investigational Site
Heidelberg
Victoria
GSK Investigational Site
Malvern
Victoria
GSK Investigational Site
Nedlands
Western Australia
GSK Investigational Site
Porto Alegre
Rio Grande do Sul
GSK Investigational Site
Curitiba
Brazil
GSK Investigational Site
Joinville
Brazil
GSK Investigational Site
São Paulo
Brazil
GSK Investigational Site
Beijing
China
GSK Investigational Site
Beijing
China
GSK Investigational Site
Changchun
China
GSK Investigational Site
Changsha
China
GSK Investigational Site
Guangzhou
China
GSK Investigational Site
Hangzhou
China
GSK Investigational Site
Jiangsu
China
GSK Investigational Site
Nanchang
China
GSK Investigational Site
Shenyang
China
GSK Investigational Site
Shenzhen
China
GSK Investigational Site
Tianjin
China
GSK Investigational Site
Wuhan
China
GSK Investigational Site
Brno
Czechia
GSK Investigational Site
Hradec Králové
Czechia
GSK Investigational Site
Prague
Czechia
GSK Investigational Site
Marseille
France
GSK Investigational Site
Toulouse
France
GSK Investigational Site
Vanduvre-lEs-Nancy
France
GSK Investigational Site
Mainz
Germany
GSK Investigational Site
Tübingen
Germany
+ 82 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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