BELANTAMAB MAFODOTIN for Relapsed/refractory multiple myeloma | Multiple myeloma

Inclusion criteria

• {"criterion_text":"- 1)\tMale or female, 18 years or older (at the time consent is obtained)"}
• {"criterion_text":"- 2)\tConfirmed diagnosis of multiple myeloma as defined by the IMWG criteria"}
• {"criterion_text":"- 3)\tPreviously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy"}
• {"criterion_text":"- 4)\tECOG performance status of 0 to 2"}
• {"criterion_text":"- 5)\tNo active infection(s) present"}
• {"criterion_text":"- 6)\tParticipants with a history of autologous SCT: a.\tASCT was >100 days prior to initiating study treatment"}
• {"criterion_text":"- 7)\tMust have at least ONE aspect of measurable disease, defined as one of the following: a.\tUrine M-protein excretion ≥200 mg/24h, or b.\tSerum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or c.\tSerum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65)."}
• {"criterion_text":"- 8)\tAll prior treatment-related toxicities (defined by NCI-CTCAE v5.0) must be ≤ Grade 1 at the time of enrollment, except for alopecia"}
• {"criterion_text":"- 9)\tAdequate organ system function as defined by the below laboratory assessments Hematologic o\tAbsolute neutrophil count (ANC) ≥1.0 x 109/L; granulocyte colony-stimulating factor (G-CSF) use is NOT allowed to reach this level for the past 14 days. o\tHemoglobin ≥ 8.0 g/dL; without blood transfusions for the past 14 days, erythropoietin is allowed. o\tPlatelet count ≥75 x 109/L; blood transfusions or platelet stimulating agents for the past 14 days are NOT allowed to reach this level. Hepatic o\tTotal bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). o\tALT ≤ 2.5xULN. Renal o\teGFR ≥30 mL/min/1.73 m2; calculated using the Modified Diet in Renal Disease (MDRD) formula. o\tSpot urine (albumin/creatinine ratio) <500 mg/g (56 mg/mmol) OR o\tUrine Dipstick: Negative/trace; if ≥1+ only eligible if confirmed <500 mg/g [56 mg/mmol] by albumin/creatinine ratio (spot urine from first void). Female Participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinicalstudies. Male Participants: Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}

Exclusion criteria

• {"criterion_text":"- 1)\tIntolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed."}
• {"criterion_text":"- 2)\tOngoing Grade 2 or higher peripheral neuropathy or neuropathic pain"}
• {"criterion_text":"- 3)\tPrior treatment with anti-BCMA therapy"}
• {"criterion_text":"- 4)\tPrior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic antimyeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter"}
• {"criterion_text":"- 5)\tPlasmapheresis within 7 days prior to the first dose of study drug"}
• {"criterion_text":"- 6)\tHas received radiotherapy to a large pelvic area (check with sponsor). Bridging radiotherapy otherwise is allowed."}
• {"criterion_text":"- 7)\tPrior allogenic stem cell transplant."}
• {"criterion_text":"- 8)\tAny major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with medical monitor."}
• {"criterion_text":"- 9)\tPresence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria given in inclusion criterium number 9."}
• {"criterion_text":"- 10)\tAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance to the study procedures"}
• {"criterion_text":"- 11)\tEvidence of active mucosal or internal bleeding"}
• {"criterion_text":"- 12)\tCirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice"}
• {"criterion_text":"- 13)\tPrevious or concurrent malignancies other than multiple myeloma, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease."}
• {"criterion_text":"- 14)\tEvidence of cardiovascular risk including any of the following: Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block"}
• {"criterion_text":"- 15)\tHistory of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months before screening"}
• {"criterion_text":"- 16)\tClass III or IV heart failure as defined by the New York Heart Association functional classification system"}
• {"criterion_text":"- 17)\tUncontrolled hypertension"}
• {"criterion_text":"- 18)\tKnown immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, bortezomib, boron or mannitol or any other components of the study treatment"}
• {"criterion_text":"- 19)\tActive infection requiring treatment"}
• {"criterion_text":"- 20)\tKnown HIV infection"}
• {"criterion_text":"- 21)\tPresence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HbcAb), at screening or within 3 months prior to first dose of study treatment."}
• {"criterion_text":"- 22)\tCurrent corneal epithelial disease except for mild punctate keratopathy"}
• {"criterion_text":"- 23)\tIntolerance or contraindications to anti-viral prophylaxis"}
• {"criterion_text":"- 24)\tSymptomatic AL amyloidosis or active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes)"}

Primary endpoints

• {"endpoint_text":"- 1. ORR, defined as the percentage of participants with a Partial Response (PR) or better (i.e., PR, Very Good Partial Response (VGPR), Complete Response (CR))","definition_or_measurement_approach":"ORR defined as the percentage of participants with a Partial Response (PR) or better (i.e., PR, Very Good Partial Response (VGPR), Complete Response (CR))."}
• {"endpoint_text":"- 2. Incidence rate of Grade ≥3 ocular adverse events according to the keratopathy visual acuity (KVA) scale","definition_or_measurement_approach":"Incidence rate of Grade ≥3 ocular adverse events measured according to the keratopathy visual acuity (KVA) scale."}

Czechia

Earliest CTIS Part Ii Submission Date

02-08-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

49

Number Of Sites

7

Number Of Participants

40

Primary sponsor

Full Name

Ceska Myelomova Skupina z.s.

Organisation Type

Patient organisation/association

Country Of Registered Address

Czechia

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

[{"id":547406,"code":"4"}]

Name

Almac Clinical Services Limited

Responsibilities

[{"id":547401,"code":"14"},{"id":547456,"code":"15","value":"QP release"}]

Third parties

• {"country":"Czechia","full_name":"Institut biostatistiky a analyz s.r.o.","duties_or_roles":"[{\"id\":547402,\"code\":\"10\"},{\"id\":547403,\"code\":\"6\"},{\"id\":547404,\"code\":\"8\"}]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"[{\"id\":547406,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"Spadia Lab a.s.","duties_or_roles":"[{\"id\":547400,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"[{\"id\":547405,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"Masarykova Univerzita","duties_or_roles":"[{\"id\":547399,\"code\":\"1\"}]","organisation_type":"Educational Institution"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"[{\"id\":547401,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"[{\"id\":547456,\"code\":\"15\",\"value\":\"QP release\"}]","organisation_type":"Pharmaceutical company"}