Dr Bradley Augustson

GlaxoSmithKline

III

Multiple Myeloma

This trial is for patients with Multiple Myeloma whose disease has returned or worsened after at least two prior treatments. Patients will be allocated into one of two arms by chance. Arm 1 patients will receive belamaf intravenously. The study drug is an infusion of an antibody which targets a protein called BCMA on myeloma cells, joined to a chemotherapy drug called MMAG. Arm 2 patients will receive pomalidomide and dexamethasone by mouth. Pomalidomide changes the immune system to attack myeloma cells. All patients will continue to receive study treatments until it stops working or if unacceptable side effects occur.

Inclusion Criteria

1. Participants must be 18 or older (Korea 19 or older), capable of giving signed informed consent
2. Histologically or cytologically confirmed diagnosis of Multiple Myeloma as defined according to IMWG criteria [Rajkumar, 2014], and:
   • Has undergone autologous stem cell transplant >100 days prior to enrolment, or is considered transplant ineligible
   • Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination)
   • Has documented disease progression on, or within 60 days of, completion of the last treatment as defined by IMWG
3. Must have measurable disease (to be confirmed by CENTRAL Q2S laboratory results during screening)
4. ECOG PS 0-2
5. All prior treatment-related toxicities ≤ Grade 1, except for alopecia and Grade 2 neuropathy
6. Adequate organ function including hematologic, hepatic, renal and cardiac functions
7. Effective contraception for female participants
8. Effective contraception for male participants

Exclusion Criteria

1. Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia
2. Prior therapy
   • BCMA-targeted or pomalidomide treatment
   • Allogenic stem cell transplant (syngenic transplant will be allowed if no GVHD)
   • Systemic MM treatment or investigational drug <14 days or 5 half-lives of first dose, whichever is shorter
   • Plasmapheresis within 7 days of first dose
   • Anti-MM mAb within 30 days of first dose
   • Major surgery within 4 weeks of first dose
3. Active infection requiring treatment
4. Known HIV
5. Hepatitis B (Positive HBsAg or HBcAb test within 3 months prior to first dose)
6. Hepatitis C – positive antibody test, positive RNA test
7. Evidence of active mucosal or internal bleeding
8. Unable to tolerate thromboembolic prophylaxis
9. History of non-infectious pneumonitis that required steroids, or current pneumonitis
10. Active renal condition that could affect participant’s safety. NOTE: Isolated proteinuria resulting from RRMM are eligible if they fulfill all other criteria
11. Current unstable liver or biliary disease per investigator as defined in study protocol
12. Evidence of cardiovascular risk with study specific criteria
13. Malignancies other than RRMM
14. Pregnant or lactating female
15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone, or any other components of study intervention

Louise Hay

louise.hay@health.wa.gov.au

08 6383 3207

GSK207495

NCT04162210