Actively Recruiting
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)
Led by GlaxoSmithKline · Updated on 2026-04-29
200
Participants Needed
6
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older at the time consent is obtained
- Confirmed diagnosis of multiple myeloma by International Myeloma Working Group criteria
- ECOG performance status of 0 to 2
- Previously treated with 1 to 2 prior lines of multiple myeloma therapy with documented disease progression
- Measurable disease with at least one of the following: urine M-protein 200 mg/24h, serum M-protein 0.5 g/dL, or involved free light chain level 10 mg/dL with abnormal ratio if no measurable M spike
- If prior autologous stem cell transplant, it must have been more than 100 days before first study dose and no active infections
- All prior treatment-related toxicities must be Grade 1 or less (except alopecia)
- Adequate organ function per laboratory tests
- Compliance with contraceptive requirements for men and women including pregnancy prevention for women of childbearing potential
- For BPd arm, prior lenalidomide treatment for at least 2 consecutive cycles
You will not qualify if you...
- Active plasma cell leukemia at screening
- Symptomatic amyloidosis including POEMS syndrome
- Previous or concurrent invasive malignancy other than multiple myeloma unless stable for 2 years or not receiving active therapy except hormonal
- Known hypersensitivity to belantamab mafodotin or related drugs
- Plasmapheresis within 7 days before first study dose
- Prior allogeneic stem cell transplant
- Major surgery within 4 weeks before treatment except bone stabilizing surgery
- Active mucosal or internal bleeding
- Intolerance or contraindications to antiviral prophylaxis
- Current corneal epithelial disease except mild punctate keratopathy
- Recent systemic anti-myeloma therapy or anti-MM monoclonal antibody within 30 days before study
- Active renal conditions affecting safety (except isolated proteinuria meeting criteria)
- Prior B-cell maturation antigen targeted therapy
- Use of contact lenses prohibited during treatment except as directed by eye care specialist
- HIV infection unless well controlled with adequate CD4+ count
- Significant liver dysfunction or unresolved hepatitis B or C infection
- Cardiovascular risks including untreated arrhythmias, recent major cardiac events, severe heart failure, uncontrolled hypertension, or QTc prolongation
- For BPd arm, prior intolerance or treatment with pomalidomide or recent thromboembolism
- For BVd arm, intolerance or refractory to bortezomib or ongoing significant neuropathy
- For BKd arm, intolerance or refractory to carfilzomib, allergy to captisol, low heart ejection fraction, recent pleural or abdominal fluid requiring drainage, intolerance to hydration, or pulmonary hypertension
AI-Screening
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Trial Site Locations
Total: 6 locations
1
GSK Investigational Site
Fort Myers, Florida, United States, 33912
Actively Recruiting
2
GSK Investigational Site
Macon, Georgia, United States, 31210
Actively Recruiting
3
GSK Investigational Site
Bethesda, Maryland, United States, 20817
Actively Recruiting
4
GSK Investigational Site
Springfield, Missouri, United States, 65807
Actively Recruiting
5
GSK Investigational Site
Farmington, New Mexico, United States, 87401
Actively Recruiting
6
GSK Investigational Site
Ehime, Japan, 790-8524
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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