Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04484623
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	GlaxoSmithKline
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	GSK Clinical Trials
Principal Investigator Affiliation	GlaxoSmithKline
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, New Zealand, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone

Active Comparator: Arm B: Bortezomib plus Pomalidomide and Dexamethasone

Interventions

Drug: - Belantamab mafodotin

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

Drug: - Pomalidomide

Immunomodulatory drug (IMiD) will be administered.

Drug: - Dexamethasone

Synthetic glucocorticoid with anti-tumor activity will be administered.

Drug: - Bortezomib

Proteasome Inhibitor will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

GSK Investigational Site, Tucson, Arizona

Status

Recruiting

Address

GSK Investigational Site

Tucson, Arizona, 85712

Site Contact

US GSK Clinical Trials Call Center

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