BELANTAMAB MAFODOTIN for Relapsed/Refractory Multiple Myeloma

Inclusion criteria

• {"criterion_text":"- Capable of giving signed informed consent"}
• {"criterion_text":"- Male and female participants agree to abide by protocol-defined contraceptive requirements"}
• {"criterion_text":"- Male or female, 18 years or older"}
• {"criterion_text":"- Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2"}
• {"criterion_text":"- Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therap. (Participants treated with lenalidomide ≥ 10mg daily for at least 2 consecutive cycles are eligible)"}
• {"criterion_text":"- Must have at least 1 aspect of measurable disease defined as one of the following: 1.Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or 2.Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (5 g/Liter [L]), or 3.Serum free light chain (FLC) assay: involved FLC level ≥10mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0,26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike"}
• {"criterion_text":"- Have undergone autologous stem cell transplant (ASCT) or are considering transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication, b. No active bacterial, viral or fungal infection(s) present"}
• {"criterion_text":"- All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤Grade 1 at the time of enrolment, except for alopecia"}
• {"criterion_text":"- Adequate organ system functions as mentioned in the protocol"}

Exclusion criteria

• {"criterion_text":"- Active plasma cell leukaemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening"}
• {"criterion_text":"- Previous or concurrent invasive malignancy other than multiple myeloma, except: 1.The disease must be considered medically stable for at least 2 years; or 2.The participant must not be receiving active therapy, other than hormonal therapy for this disease"}
• {"criterion_text":"- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment"}
• {"criterion_text":"- Evidence of active mucosal or internal bleeding"}
• {"criterion_text":"- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, eoshageal or gastric varices, persistent jaundice"}
• {"criterion_text":"- Active infection requiring treatment"}
• {"criterion_text":"- Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met"}
• {"criterion_text":"- Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety)"}
• {"criterion_text":"- Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy"}
• {"criterion_text":"- Active or history of peripheral venous and arterial thromboebolism within the past 3 months"}
• {"criterion_text":"- Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis"}
• {"criterion_text":"- Prior allogeneic SCT"}
• {"criterion_text":"- Current corneal disease except for mild punctate keratopathy"}
• {"criterion_text":"- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures"}
• {"criterion_text":"- Pregnant or lactating female"}
• {"criterion_text":"- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs"}
• {"criterion_text":"- Plasmapharesis within 7 days prior to the first dose of study drug"}
• {"criterion_text":"- Received prior treatment with or intolerant to pomalidomide"}
• {"criterion_text":"- Received prior Beta cell maturation antigen (BCMA) targeted therapy"}
• {"criterion_text":"- Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly)"}
• {"criterion_text":"- Evidence of cardiovascular risk including any of the following: 1.Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block 2.Recent history (within 3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting 3.Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system 4.Uncontrolled hypertension"}
• {"criterion_text":"- Any major surgery within the last 4 weeks"}

Primary endpoints

• {"endpoint_text":"- Progression-Free Survival (PFS), defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to any caus","definition_or_measurement_approach":"Time from randomization until earliest date of progressive disease (PD) based on Independent Review Committee (IRC) assessment per IMWG criteria, or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS), defined as the interval of time from randomization to the date of death due to any cause","definition_or_measurement_approach":"Interval of time from randomization to date of death due to any cause (overall survival)."}
• {"endpoint_text":"- Duration of Response (DoR), defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any progressive disease (PD) or death due to any per IMWG criteria. MRD negativity rate, defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10-5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG","definition_or_measurement_approach":"DoR: time from first documented PR or better until PD or death per IMWG; MRD negativity rate assessed by NGS at 10^-5 threshold during confirmed CR or better per IRC/IMWG."}
• {"endpoint_text":"- Overall Response Rate (ORR,), defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria","definition_or_measurement_approach":"Percentage of participants with confirmed PR or better (PR, VGPR, CR, sCR) per IRC assessment using IMWG criteria."}
• {"endpoint_text":"- Complete Response Rate (CRR,), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR))) based on IRC assessment per IMWG criteria","definition_or_measurement_approach":"Percentage of participants with confirmed CR or better (CR and sCR) per IRC assessment using IMWG criteria."}
• {"endpoint_text":"- Very Good Partial Response (VGPR) or better rate, defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria","definition_or_measurement_approach":"Percentage of participants with confirmed VGPR or better (VGPR, CR, sCR) per IRC/IMWG criteria."}
• {"endpoint_text":"- Time to Best Response (TTBR), defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG","definition_or_measurement_approach":"Interval between randomization and earliest date of best response among participants with confirmed PR or better per IRC/IMWG."}
• {"endpoint_text":"- Time to Response (TTR), defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG","definition_or_measurement_approach":"Time from randomization to first documented evidence of response (PR or better) per IRC/IMWG."}
• {"endpoint_text":"- Time to Progression (TTP), defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD","definition_or_measurement_approach":"Time from randomization to earliest date of PD per IRC/IMWG or death due to PD."}
• {"endpoint_text":"- PFS2, defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlie","definition_or_measurement_approach":"Time from randomization to investigator-assessed progression after new anti-myeloma therapy or death; if progression after new therapy cannot be measured, event defined as discontinuation of new therapy or death."}
• {"endpoint_text":"- Incidence of AEs and changes in laboratory parameters","definition_or_measurement_approach":"Incidence rates of adverse events and laboratory parameter changes as recorded during the trial (safety monitoring)."}
• {"endpoint_text":"- Ocular findings on ophthalmic exam","definition_or_measurement_approach":"Findings from ophthalmic examinations (ocular safety assessments)."}
• {"endpoint_text":"- Plasma concentrations of belantamab mafodotin and cys-mcMMAF","definition_or_measurement_approach":"Measurement of plasma concentrations of belantamab mafodotin and cys-mcMMAF (PK assessments)."}
• {"endpoint_text":"- Derived PK parameter values, as data permit","definition_or_measurement_approach":"Derived pharmacokinetic parameter values (e.g., AUC, Cmax) as data permit."}
• {"endpoint_text":"- Incidence and titers of ADAs against belantamab mafodotin","definition_or_measurement_approach":"Incidence and titers of anti-drug antibodies (ADA) versus belantamab mafodotin measured during study."}
• {"endpoint_text":"- Maximum post-baseline PRO-CTCAE score or each item attribute","definition_or_measurement_approach":"Maximum post-baseline PRO-CTCAE score per item attribute reported by participants."}
• {"endpoint_text":"- Change from baseline in HRQOL as measured by EORTC QLQ-C30, EORT QLQ-MY20 and EORTC IL52","definition_or_measurement_approach":"Change from baseline in health-related quality of life measured by EORTC QLQ-C30, QLQ-MY20 and IL52 instruments."}

Czechia

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

595

Number Of Sites

3

Number Of Participants

26

Greece

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

532

Number Of Sites

5

Number Of Participants

50

Germany

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

532

Number Of Sites

1

Number Of Participants

4

Poland

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

14-12-2025

Processing Time Days

537

Number Of Sites

5

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

538

Number Of Sites

3

Number Of Participants

3

Italy

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

534

Number Of Sites

4

Number Of Participants

17

Spain

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

534

Number Of Sites

14

Number Of Participants

33

Primary sponsor

Full Name

Glaxosmithkline Research & Development Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

IQVIA Limited

Responsibilities

IVRS - treatment randomisation, CoE ophthalmology consultancy group; codes:1,12,15,2,5,6,8

Name

IQVIA RDS Hellas Single Member S.A.

Responsibilities

Clinical Monitoring, Safety Reporting and Regulatory Applications in Greece

Name

Parexel International Corp.

Responsibilities

Independent review committee - efficacy endpoints

Name

Syneos Health Inc.

Responsibilities

Operational/vendor support (sponsorDuties code:4 as listed in dossier)

Third parties

• {"country":"United States","full_name":"Acetaminophen Toxicity Diagnostics LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"Cerba","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Marken LLP","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc. (Chantilly)","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Clinical Monitoring, Safety Reporting and Regulatory Applications in Greece","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Oracle Corp.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc. (San Juan Capistrano)","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes:1,12,15,2,5,6,8; value: IVRS - treatment randomisation, CoE ophthalmology consultancy group","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"International Drug Development Institute Inc.","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA & ePRO (code:15)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Independent review committee - efficacy endpoints (code:15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Lost to follow up patient search - key secondary endpoint (code:15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}