None listed
Conditions
Interventions
Drug : Belantamab mafodotin is administered in combination with bortezomib and dexamethasone (BVd).
Belantamab mafodotin is administered at a dose of 2.5mg/kg every 3 weeks on Day 1 of each cycle, inf
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PPatients are eligible to be included in the Programme only if all of the following criteria apply: 1. Written informed consent can be obtained from the patient or legally authorised representative as per local regulations. 2. Diagnosis of Multiple Myeloma and relapsed or refractory after treated with one and only one prior lines of MM therapy and a. must have documented disease progression during or after their most recent therapy b. NOTE: induction + Autologous Stem Cell Transplantation + maintenance is 1 line of therapy. 3. 19 years or older (at the time consent is obtained) 4. Able to obtain ophthalmic examination (including visual acuity and slit lamp examination) at baseline, before the subsequent 3 treatment cycles, and as clinically indicated on treatment. 5. Required Contraception Female Patients: A female patient is eligible to participate if one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using an effective contraceptive method during treatment with belantamab mafodotin and for 4 months after the last dose. The patient must also have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discuss with GSK physician if the patient is pregnant, breast-feeding or planning to have a baby. Male Patients: Male patients with female partners of childbearing potential are eligible to participate if they agree to use effective contraception during treatment with belantamab mafodotin until 6 months after the last dose The patient is willing to abide by the contraception requirements.
Exclusion criteria
Exclusion criteria: Patients are excluded from the Programme if any of the following criteria apply: 1. Intolerant or refractory to bortezomib/dexamethasone. 2. Previously exposed on belantamab mafodotin 3. ALT >2.5xULN. 4. Total bilirubin >1.5xULN; patients with Gilbert’s syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is =1.5xULN. 5. Cirrhosis or current unstable liver or biliary disease per physician assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. Note: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or asymptomatic gallstones) is acceptable if patient otherwise meets entry criteria). 6. Patients with Hepatitis B will be excluded unless the following criteria can be met, 6-1) HbcAb+, HbsAg- a. Screening: During Programme Treatment b. During Programme Treatment: ? Monitoring per standard of care ? Antiviral treatment instituted if HBV DNA becomes detectable 6-2) HbcAb+, HbsAg- a. Screening: ? HBV DNA detectable ? On-going antiviral therapy with stable or decreasing HBV DNA b. During Programme Treatment: Monitoring and management per standard of care 6-3) HBsAg+ at screen or within 3 months prior to first dose a. Screening: ? HBV DNA undetectable ? Antiviral therapy started at least 4 weeks before the first dose b. During Programme Treatment: ? Antiviral treatment maintained throughout programme treatment ? Monitoring and management per standard of care Note: Presence of isolated Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a patient 7. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of programme treatment unless the patient can meet the following criteria: a. RNA test negative b. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks. 8. Evidence of active bleeding requiring intervention. 9. Currently active Graft-versus-Host Disease (GvHD). 10. Known hypersensitivity to the active substance or to any of the excipients 11. Active infection requiring treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression-Free Survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Progression-Free Survival;time to response;Duration of Response | — |
Countries
Korea, Republic of
Contacts
Public ContactJIN SEOK Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed