An Expanded Access Program for belantamab mafodotin in Patients with Relapsed/Refractory Multiple Myeloma

JRCT ID: jRCT2031210607

Registered date:15/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 31/03/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Belantamab mafodotin (anti-BCMA (B-cell maturation antigen) monoclonal antibody (mAb))
Intravenous infusion on Day1 of each 21-day cycle, 2.5mg/kg

Outcome(s)

• Primary Outcome: Safety and efficacy of belantamab mafodotin

Key inclusion & exclusion criteria

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

Include 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.Have 2 or more prior lines of anti-myeloma 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

Exclude 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

Related Information

• Primary Sponsor: Ishibashi Hideyasu