Relapsed/Refractory Multiple Myeloma
Conditions
Interventions
Belantamab mafodotin will be administered intravenously (IV) at a single dose of 2.5 mg/kg on Day 1 (D1) of Cycle 1 and 1.9 mg/kg in Cycle 2 and beyond (2+) of every 28-day cycle
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -18 years or older (at the time consent is obtained) -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 -Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. -Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles) and must have documented disease progression during or after their most recent therapy. -Adequate organ system functions as defined by the laboratory assessments listed in study protocol
Exclusion criteria
Exclusion criteria: - Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes). - Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) or use of an investigational drug 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. - Received prior treatment with or intolerant to pomalidomide - Received prior BCMA targeted therapy - Plasmapheresis within 7 days prior to the first dose of study drug. - Participants after prior allogeneic SCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS), defined as the time from the date of randomization until the earliest date of documented disease progression or death due to any cause | — |
Countries
Australia, Canada, Czech Republic, France, Germany, Greece, Israel, Italy, Japan, Korea, New Zealand, Poland, Russia, Spein, Turkey, UK, USA
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed