Health Condition 1: - Health Condition 2: D758- Other specified diseases of bloodand blood-forming organs Health Condition 3: D758- Other specified diseases of bloodand blood-forming organs
Conditions
Interventions
Intervention1: Single-Agent
Belantamab Mafodotin (GSK2857916): GSK2857916 for injection, 100 mg, Biologic/drug (antibody-drug conjugate) ,Lyophilized powder in single-use vial for reconstitution, 100
Sponsors
GlaxoSmithKline Research Development Limited
GlaxoSmithKline Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 18 or older, capable of giving signed informed consent ECOG Performance Status 0-2 Histologically or cytologically confirmed diagnosis of: Multiple Myeloma as defined according to IMWG, 2014 criteria [Rajkumar, 2014], and: Has undergone autologous stem cell transplant ( >100 days), or is considered transplant ineligible, Has received at least 3 prior lines, including an anti-CD38 antibody and is refractory to an immunomodulatory agent and a proteasome inhibitor Must have measurable disease Serum M-protein >=0.5 g/dL (>=5 g/L), or Urine M-protein >=200 mg/24h, or Serum Free Light Chain (FLC) assay: Involved serum FLC level >=5 mg/dL (>=50 mg/L) and an abnormal serum FLC ratio ( 1.65) or Prior treatment-related toxicities must be Life expectancy of at least 6 months Sex and Contraception/Barrier Requirements: Female: Unless not a WOCBP, use highly effective contraceptive method (failure rate of Male: Be abstinent from heterosexual intercourse OR agree to use a male condom and female partner to use an additional highly effective contraceptive method throughout study treatment including the 6-month follow-up period even if they have undergone a successful vasectomy
Exclusion criteria
Exclusion criteria: Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia Corneal epithelial disease, except nonconfluent superficial punctate keratitis Evidence of active mucosal or internal bleeding Presence of renal or liver condition, active infection requiring treatment, serious or unstable medical conditions, other malignancies, protocol-defined cardiovascular risk/disease, pregnancy/lactation (female), recent major surgery Presence of HIV, Hepatitis B, Hepatitis C (as per protocol requirements) Prior therapy with: Systemic MM treatment Steroids (equivalent to >= 60 mg prednisone daily for >=4 days) within 14 days BCMA-targeted therapy, or Hypersensitivity to study treatment Investigational drug ( Plasmapheresis within 7 days of first dose Anti-MM mAb within 30 days of first dose Allogenic stem cell transplant (syngeneic transplant will be allowed if no GVHD) Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: Absolute neutrophil count Hemoglobin Platelet count Spot urine (albumin/creatinine ratio) >500 mg/g (56 mg/mmol) eGFR Note: Laboratory results obtained during screening must be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent within range screening result may be used to confirm eligibility. Note: Supportive care as needed, including transfusion of blood products or growth factors, prior to or during the study is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of Grade â?¥2 ocular AEs according to KVA scale is primary endpoint calculated as the percentage of participants with Grade â?¥2 ocular AEs assessed by KVA scale. Incidence rate of ocular AEs by grade (KVA scale). Exposure-adjusted incidence Median duration of dose delay. % of participants requiring dose. % of participants requiring dose delay % of participants requiring study treatment discontinuationTimepoint: Incidence rate of Grade â?¥2 ocular AEs according to the KVA scale is the primary endpoint. It is calculated as the percentage of participants with Grade â?¥2 ocular AEs assessed by KVA scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| To further evaluate the ocular safety and tolerability of single-agent belantamab mafodotin in all armsTimepoint: Cumulative event rate of ocular AEs to Week 16 (KVA scale. Incidence rate of ocular AEs by grade (KVA Scale). Exposure-adjusted incidence rate of ocular AE by grade (KVA scale). Median duration of dose delay. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to ocular AEs (KVA scale). Cumulative incidence of ocular AEs by grade (KVA scale). Toxicity Index by assessment/visit. Duration of ocular AEs (KVA scale) | — |
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Greece, India, Ireland, Italy, Poland, Republic of Korea, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactSwapnali A Raut
GlaxoSmithKline Pharmaceuticals Ltd
Outcome results
None listed