NIPH Clinical Trials Search

JRCT ID: jRCT2011210067

Registered date:01/02/2022

A Phase III Study of Belantamab Mafodotin plus Pomalidomide and Dexamethasone vs Pomalidomide, Bortezomib and Dexamethasone in Participants with RRMM

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRelapsed/Refractory Multiple Myeloma
Date of first enrollment08/03/2022
Target sample size20
Countries of recruitmentUSA,Japan,Canada,Japan,Italy,Japan,Spein,Japan,Poland,Japan,Turkey,Japan,France,Japan,Czech Republic,Japan,Germany,Japan,Israel,Japan,UK,Japan,Russia,Japan,Greece,Japan,Korea,Japan,Australia,Japan,New Zealand,Japan
Study typeInterventional
Intervention(s)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


Primary OutcomeProgression-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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include 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
Exclude 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.

Related Information


Public contact
Name jRCT Call Center IQVIA Services Japan K.K.
Address 4-10-18 Takanawa, Minato-ku,Tokyo 108-0074 Japan Tokyo Japan 108-0074
Telephone +81-120-229-053
Affiliation IQVIA Services Japan K.K.
Scientific contact
Name Yuki Kakinuma
Address 4-10-18 Takanawa, Minato-ku,Tokyo 108-0074 Japan Tokyo Japan 108-0074
Telephone +81-120-229-053
Affiliation IQVIA Services Japan K.K.