Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation
This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
• Age \>= 18 years of age at time of consent
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG), 2016 criteria, and
‣ Patient is considered transplant eligible, and
⁃ Is not MRD negative complete response (CR) after high dose chemotherapy
• Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L (within 14 days of first dose of study treatment)
• Hemoglobin \>= 8.0 g/dL (within 14 days of first dose of study treatment)
• Platelets \>= 75 X 10\^9/L (within 14 days of first dose of study treatment)
• Total bilirubin =\< 1.5 X upper limit of normal (ULN) (isolated bilirubin \>= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) (within 14 days of first dose of study treatment)
• Alanine aminotransferase (ALT) =\< 2.5 X ULN or \< 5 times ULN if documented liver infiltration (within 14 days of first dose of study treatment)
• Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ 1.73 m\^2 (within 14 days of first dose of study treatment)
• Spot urine (albumin/creatinine ratios (spot urine) \< 500 mg/g (56 mg/mmol) OR urine dipstick Negative/trace (if \>= 1+ only eligible if confirmed =\< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) (within 14 days of first dose of study treatment)
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
‣ Not a woman of childbearing potential (WOCBP) OR
⁃ A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period
• Female participants of childbearing potential are to have a negative serum pregnancy test within 24 hours before the first dose of study intervention
• A male participant must agree to use an adequate method of contraception (as described below) during the treatment period and for at least 6 months after the last dose of study treatment to allow for clearance of any altered sperm, along with the following:
‣ Refrain from donating sperm PLUS either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
∙ Must agree to use contraception/barrier
• All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be =\< grade 1 at the time of enrolment except for alopecia
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure