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Clinical Trials in the USA / NCT07227311
Recruiting Phase 2

A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)

NCT07227311 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2026-04-15
Last updated
2026-08-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Belantamab mafodotinDexamethasonePomalidomideBortezomibCarfilzomib

Belantamab mafodotin: Belantamab mafodotin will be administered.

Dexamethasone: Dexamethasone will be administered.

Pomalidomide: Pomalidomide will be administered.

Bortezomib: Bortezomib will be administered.

Carfilzomib: Carfilzomib will be administered.

Study summary

This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.

The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: • Participants are eligible to be included in the study only if all of the following criteria apply: Applicable to All Arms - BPd, BVd, BKd: * Male or female, 18 years or older (at the time consent is obtained). * 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 zero to 2. * Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy. * Must have at least 1 aspect of measurable disease, defined as one the following: 1. Urine M-protein excretion ≥200 mg/24 h, or 2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or 3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\<0.26 or \>1.65) only if patient has no measurable urine or serum M spike. * Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met: 1. ASCT was \>100 days prior to the first dose of study medication, 2. 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 \[NCI-CTCAE\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia. * Adequate organ system functions as defined by the laboratory assessments. * Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception. * Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential. Specific Inclusion Criteria for BPd arm: • Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Applicable for all (BPd, BVd, BKd): * Active plasma cell leukemia at Screening. * Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS). * Previous or concurrent invasive malignancy other than MM, except: 1. The disease must be considered medically stable for at least 2 years; or 2. The patient 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. * Plasmapheresis within 7 days prior to the first dose of study intervention. * Patients after prior allogeneic stem cell transplant * Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery. * Evidence of active mucosal or internal bleeding. * Intolerance or contraindications to anti-viral prophylaxis. * Current corneal epithelial disease except for mild punctate keratopathy. * Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention. * Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria * Received prior B-cell maturation antigen (BCMA)-targeted therapy. * Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist. * HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count. * Significant liver dysfunction (ALT \>2.5x ULN, bilirubin \>1.5x ULN, cirrhosis, unstable liver/biliary disease). * Positive hepatitis B or C markers unless criteria for resolved infection are met. * Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI/ACS/angioplasty/bypass, NYHA III/IV heart failure, uncontrolled hypertension, QTc prolongation. Specific Exclusion Criteria for BPd Arm: * Received prior treatment with or intolerant to pomalidomide. * Active or history of venous and arterial thromboembolism within the past 3 months. Specific Exclusion Criteria for BVd Arm: * Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m² twice weekly or within 60 days of completing that treatment). * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. Specific Exclusion Criteria for BKd Arm: * Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment). * Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib. * Left ventricular ejection fraction \<40% as assessed by transthoracic echocardiogram. * Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment. * Intolerance to hydration due to pre-existing pulmonary or cardiac impairment. * Known pulmonary hypertension.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
GSK Investigational Site Los Alamitos California Recruiting
GSK Investigational Site Torrance California Recruiting
GSK Investigational Site Whittier California Recruiting
GSK Investigational Site Norwich Connecticut Recruiting
GSK Investigational Site Fort Myers Florida Recruiting
GSK Investigational Site Macon Georgia Recruiting
GSK Investigational Site Baton Rouge Louisiana Recruiting
GSK Investigational Site Bethesda Maryland Recruiting
GSK Investigational Site Bridgeton Missouri Recruiting
GSK Investigational Site Springfield Missouri Recruiting
GSK Investigational Site Farmington New Mexico Recruiting
GSK Investigational Site Nashville Tennessee Recruiting
GSK Investigational Site Dunkirk Nord Recruiting
GSK Investigational Site Nantes France Recruiting
GSK Investigational Site Paris France Recruiting
GSK Investigational Site Paris France Recruiting
GSK Investigational Site Paris France Recruiting
GSK Investigational Site Saint-Etienne France Recruiting
GSK Investigational Site Frankfurt Germany Recruiting
GSK Investigational Site Hamburg Germany Recruiting
GSK Investigational Site Karlsruhe Germany Recruiting
GSK Investigational Site Koblenz Germany Recruiting
GSK Investigational Site München Germany Recruiting
GSK Investigational Site Thessaloniki Central Macedonia Recruiting
GSK Investigational Site Athens Greece Recruiting
GSK Investigational Site Athens Greece Recruiting
GSK Investigational Site Periohi Dragana Alexand Greece Recruiting
GSK Investigational Site Thessaloniki Greece Recruiting
GSK Investigational Site Aichi Japan Recruiting
GSK Investigational Site Chiba Japan Recruiting
GSK Investigational Site Ehime Japan Recruiting
GSK Investigational Site Fukushima Japan Recruiting
GSK Investigational Site Gunma Japan Recruiting
GSK Investigational Site Hokkaido Japan Recruiting
GSK Investigational Site Ishikawa Japan Recruiting
GSK Investigational Site Numakunai Japan Recruiting
GSK Investigational Site Okayama Japan Recruiting
GSK Investigational Site Osaka Japan Recruiting
GSK Investigational Site Sendai Japan Recruiting
GSK Investigational Site Tokyo Japan Recruiting

+ 19 more sites — see the full list on the official registry below.

More GlaxoSmithKline trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT07227311 on ClinicalTrials.gov ↗ ← All trials in the USA