RecruitingMultiple Myeloma

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.