Relapsed/Refractory Multiple Myeloma
Conditions
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 or older - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Subjects who have undergone autologous stem cell transplantation (SCT) or have been deemed ineligible for transplantation - Subjects with a history of two or more lines of anti-myeloma therapy, who have received both lenalidomide and proteasome inhibitors (either as monotherapy or in combination) for at least two consecutive cycles, and have shown progression during the most recent treatment or within 60 days after the end of treatment - Patients with adequate organ function as defined by the clinical trial protocol - Other selection criteria as defined in the clinical trial protocol may also apply
Exclusion criteria
Exclusion criteria: - Subjects with symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or active plasma cell leukemia at the time of screening. - Subjects who have received any systemic therapy for multiple myeloma or any investigational drug within 13 days or 5 times the half-life (whichever is shorter) prior to the first dose of the investigational drug. - Subjects who have received monoclonal antibody therapy for MM within 30 days prior to the first dose of the investigational drug. - Subjects with a history of BCMA-targeted therapy or pomalidomide treatment. - Subjects who have undergone plasmapheresis within 7 days prior to the first dose of the investigational drug. - Subjects with a history of allogeneic stem cell transplantation. - Other exclusion criteria as defined in the clinical trial protocol may also apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy PFS, defined as the time from the date of randomization until the earliest date of documented disease progression (according to IMWG Response Criteria) or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| - OS, defined as the time from randomization until death due to any cause ORR, defined as the percentage of participants with a confirmed PR or better per IMWG - Clinical benefit rate (CBR), defined as the percentage of participants with a onfirmed minimal response (MR) or better per IMWG - DoR, defined as the time from first documented evidence of PR or better until PD per IMWG or death due to any cause among participants who achieve confirmed PR or better | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline k.k.
Outcome results
None listed