A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)
This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment. The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.
∙ • Participants are eligible to be included in the study only if all of the following criteria apply:
∙ Applicable to All Arms - BPd, BVd, BKd:
• Male or female, 18 years or older (at the time consent is obtained).
• Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.
• Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.
• Must have at least 1 aspect of measurable disease, defined as one the following:
‣ Urine M-protein excretion ≥200 mg/24 h, or
⁃ Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
⁃ Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\<0.26 or \>1.65) only if patient has no measurable urine or serum M spike.
• Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:
‣ ASCT was \>100 days prior to the first dose of study medication,
⁃ No active bacterial, viral, or fungal infection(s) present.
• All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.
• Adequate organ system functions as defined by the laboratory assessments.
• Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.
• Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.
∙ • Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.