Trattamento

Experimental: Cohort 1: Participants receiving Belantamab Mafodotin at dose level (DL) 1

Experimental: Cohort 2: Participants receiving Belantamab Mafodotin at DL 2

Experimental: Cohort 3: Participants receiving Belantamab Mafodotin at DL 3

Experimental: Cohort 4: Participants receiving Belantamab Mafodotin at DL 4

Experimental: Cohort 5: Participants receiving Belantamab Mafodotin at DL4 with alternative dose modification

Obiettivo primario

Incidence rate of Grade ≥2 ocular adverse events (AEs) according to the keratopathy visual acuity (KVA) scale [ Time Frame: Up to 12 months ]

KVA scale is used to grade the ocular AEs from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea [Grade 0] to corneal ulcer [Grade 4]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity [Grade 0] to visual acuity worse than 1.0 logarithm of the minimum angle of resolution ([logMAR] (20/200) [Grade 4]). The KVA grade is driven by the most severe finding.

Criteri di inclusione

• Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-MM therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
• Participant has measurable disease per modified IMWG criteria.
• Life expectancy of at least 6 months, in the opinion of the investigator.
• Male and female participants agree to abide by protocol-defined contraceptive requirements.
• Participant is capable of giving signed informed consent.
• Participant meets country-specific inclusion criteria described in the protocol.

Criteri di esclusione

• Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-MM therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
• Participant has measurable disease per modified IMWG criteria.
• Life expectancy of at least 6 months, in the opinion of the investigator.
• Male and female participants agree to abide by protocol-defined contraceptive requirements.
• Participant is capable of giving signed informed consent.

Participant meets country-specific inclusion criteria described in the protocol.