Multiple Myeloma
Conditions
Interventions
Part1
Belantamab mafodotin (anti-BCMA (B-cell maturation antigen) monoclonal antibody (mAb))
Intravenous infusion on Day1 of each 21-day cycle, 2.5mg/kg
Part2
-Belantamab mafodotin (anti-BCMA (B-cell
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed diagnosis of MM as defined according to International Myeloma Working Group (IMWG), and: a. Has undergone autologous stem cell transplant (ASCT), or is considered transplant ineligible b. There is no effective therapy or other therapy is not an option c. Subjects who meet any of the following: i) Monotherapy: subjects who have received at least 2 prior lines of therapy for MM. ii) Combination therapy with Bor/dex: Subject must have received at least 1 prior line of therapy for MM and had disease progression during or after the last therapy or was intolerant to the last therapy. iii) Combination therapy with pomalidomide/dex: Subject must have received at least 1 prior line of therapy for MM and have had disease progression during or after the last therapy or are intolerant to the last therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, or 3 due to bone lesions are eligible. - All prior treatment-related toxicities (defined by National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be <-Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy. - Adequate organ system function as defined by the laboratory assessments
Exclusion criteria
Exclusion criteria: -Prior allogenic stem cell transplant. -Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain Prior malignancies. -Current corneal epithelial disease except for mild punctate keratopathy -Patients eligible for Any other ongoing GSK-sponsored studies of belantamab mafodotin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of belantamab mafodotin, belantamab mafodotin in combination with bortezomib/dexamethasone (BVd) and belantamab mafodotin in combination with pomalidomide/dexamethasone (BPd) | — |
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed