A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
The study consists of two parts: Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with belantamab (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).
• Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
• Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG).
• 1\. Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable) and have confirmed progression on or following the last line of treatment.
• Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:
‣ transplant was greater than (\>)100 days prior to screening.
⁃ no active infection(s)
• Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.
• Measurable disease defined as at least ONE of the following:
‣ Serum M-protein concentration greater than (\>=) 0.5 gram (g)/ deciliter (dL) (\>=5 gram/liter \[g/L\])
⁃ Urine M-protein excretion \>=200 mg/24 hours (\>=0.2 g/24 hours)
⁃ Serum free light chain (FLC) assay: involved FLC level \>=10 mg/dL (\>=100 milligrams per liter \[mg/L\]) and an abnormal serum FLC ratio (less than \[\<\]0.26 or \>1.65)
• Have adequate organ system function as defined by the laboratory assessments.
• All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], v5.0, 2017) must be Grade \<=1 at the time of screening except for alopecia (any grade), neuropathy (Grade \<=2), or endocrinopathy managed with replacement therapy (any grade).
• Participants or Legally authorized representative (LAR) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.