BELANTAMAB MAFODOTIN-BLMF INJ

Clinical Criteria Summary

Absolute Neutrophil Count < 1000/mm3 unless Duffy Null phenotype
Platelet count < 75,000/mm3
Creatinine clearance < 30 ml/min
Moderate to severe hepatic impairment (Child Pugh B, C or NCI Organ Dysfunction Working Group Classification)
Corneal epithelial disease, except mild punctate keratopathy
Active or uncontrolled infection
Pregnancy
Lactating
Refractory or intolerant to bortezomib
Received prior treatment with a BCMA-targeting therapy (i.e. idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, elranatamab, linvoseltamab)

Multiple Myeloma diagnosis
Documented myeloma disease progression on at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent
Care provided by a VA or VA Community Care hematology/oncology provider
Goals of care and role of Palliative Care consult have been discussed and documented
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
All REMS requirements have been met for provider, patient, and healthcare setting
Co-management with eye care professional (i.e. ophthalmologist or optometrist) required for monitoring
Eye care professional provided drug information prior to first dose
Baseline eye exam including visual acuity and slit lamp within 3 weeks of first dose
Patient able to administer preservative-free lubricant eye drops at least 4 times daily starting with first infusion and continuing until course of therapy completion
Patient able to avoid wearing contact lenses during treatment, unless directed by eye care professional

For females who can become pregnant: Pregnancy must be excluded prior to receiving belantamab.
For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 4 months after stopping treatment
For males with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment
For females who are lactating / providing breastmilk to an infant or planning to do so: Counseling provided advising women not to breastfeed during therapy and for 3 months after stopping treatment.

Treatment of adult patients with relapsed or refractory multiple myeloma (RRMM)
Positioned for multiply relapsed myeloma patients who are not candidates for CAR T-cell therapy or bispecific T-cell engager therapy

Must have received at least two prior lines of therapy
Prior therapies must include a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD)

Administered in combination with bortezomib and dexamethasone (BVd regimen)
Belantamab mafodotin-blmf dose: 2.5 mg/kg IV every 3 weeks for 8 cycles, followed by 2.5 mg/kg IV every 3 weeks as monotherapy until disease progression or unacceptable toxicity
Bortezomib dosing: 1.3 mg/m2 SQ on days 1, 4, 8, and 11
Dexamethasone dosing: 20 mg IV or PO on the day of and the day after bortezomib for cycles 1-8

Available exclusively through the restricted BLENREP REMS program
Requires proactive ophthalmologic monitoring at baseline and throughout treatment due to significant ocular toxicity risk
Monitor complete blood count (CBC) at baseline and periodically; withhold or reduce dose based on thrombocytopenia severity
Verify pregnancy status prior to initiation

Contraindications: None explicitly stated
Embryo-Fetal Toxicity: Advise use of effective contraception during treatment and for 4 months after the last dose in females, or 6 months after the last dose in males
Lactation: Advise against breastfeeding during treatment and for 3 months after the final dose
Renal Impairment: No dose adjustments recommended for mild to severe renal impairment or kidney failure (eGFR <30 mL/min)
Hepatic Impairment: No dose adjustment required for mild hepatic impairment; effects of moderate or severe hepatic impairment are unknown

VA Plasma Cell Disorders Pathway v1.2026: Directed to BVd for multiply relapsed myeloma if not a candidate for CAR T-cell therapy or bispecific T-cell engager as monotherapy (Teclistamab)
NCCN Guidelines v5.2026: Classified as "Other Recommended" (Category 1) after >2 prior lines of therapy including a PI and IMiD