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

JRCT ID: jRCT2011210067

Registered date:01/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed/Refractory Multiple Myeloma
• Date of first enrollment: 08/03/2022
• Target sample size: 20
• Countries of recruitment: USA,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 type: Interventional
• 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

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Ishibashi Hideyasu
• Secondary ID(s): NCT04484623