BELANTAMAB MAFODOTIN for Multiple myeloma | Relapsed or refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Participant must be 18 years of age inclusive or older.\n- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n- Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line)\n- RRMM with measurable disease: Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or\n- RRMM with measurable disease: Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or\n- RRMM with measurable disease: Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio <0.26 or >1.65).\n- Men or woman or childbearing potential should agree to use contraception.\n- Substudies 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. “Refractory” is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy."}

Exclusion criteria

• {"criterion_text":"- Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.\n- Participants with a contraindication to treatment.\n- Vaccination with a live vaccine 4 weeks before the start of the study.\n- Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted\n- Hemoglobin <8 g/dL.\n- Platelets <50 × 10^9/L.\n- Absolute neutrophil count <1.0 × 10^9/L\n- Creatinine clearance <30 mL/min/1.73m2.\n- Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN\n- Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN.\n- Patients with grade 3 or 4 hypercalcemia\n- Uncontrolled infection within 14 days prior to first study intervention administration.\n- Substudy 03:Current corneal epithelial disease except mild punctate keratopathy\n- Substudy 03:Patients who have received prior therapy with belantamab mafodotin.\n- Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction <40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0).\n- Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A.\n- Uncontrolled or active hepatitis B virus (HBV) infection.\n- Active hepatitis C virus (HCV) infection.\n- Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease.\n- Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention administration.\n- Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone"}

Primary endpoints

• {"endpoint_text":"- Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab","definition_or_measurement_approach":"Dose-finding objective in Part 1 to determine or confirm recommended dose of novel agents when combined with isatuximab (dose escalation/dose finding design)."}
• {"endpoint_text":"- Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)","definition_or_measurement_approach":"Measurement: rate of very good partial response (VGPR) or better in Part 2 expansion/controlled substudies."}

Secondary endpoints

• {"endpoint_text":"- Part 1 (dose finding, experimental substudies): ORR","definition_or_measurement_approach":"Overall response rate (ORR) measured per study response criteria in Part 1."}
• {"endpoint_text":"- Part 2 (expansion, controlled experimental substudies): ORR","definition_or_measurement_approach":"Overall response rate (ORR) measured per study response criteria in Part 2."}
• {"endpoint_text":"- Part 1 (dose finding, experimental substudies): VGPR or better","definition_or_measurement_approach":"Rate of VGPR or better in Part 1."}
• {"endpoint_text":"- Clinical Benefit Rate (CBR) in each treatment arm","definition_or_measurement_approach":"Clinical benefit rate assessed per protocol in each treatment arm."}
• {"endpoint_text":"- Duration of Response (DOR) in each treatment arm","definition_or_measurement_approach":"Duration of response measured from first documented response until progression or death in each arm."}
• {"endpoint_text":"- Time to First Response (TT1R) in each treatment arm","definition_or_measurement_approach":"Time from first study intervention to first documented response in each arm."}
• {"endpoint_text":"- Time to Best Response (TTBR) in each treatment arm","definition_or_measurement_approach":"Time from first study intervention to best documented response in each arm."}
• {"endpoint_text":"- Number of participants with treatment emergent adverse events and serious adverse events in each treatment arm","definition_or_measurement_approach":"Counts and rates of TEAEs and SAEs per arm (safety monitoring)."}
• {"endpoint_text":"- Progression-free survival (PFS) in each treatment arm","definition_or_measurement_approach":"PFS measured as time from randomization/first dose to progression or death in each arm."}
• {"endpoint_text":"- Overall Survival (OS) in each treatment arm","definition_or_measurement_approach":"OS measured as time from randomization/first dose to death from any cause in each arm."}
• {"endpoint_text":"- Immunogenicity of isatuximab and novel agents","definition_or_measurement_approach":"Assessment of anti-drug antibodies/immunogenicity assays for isatuximab and novel agents when applicable."}
• {"endpoint_text":"- Concentration of novel agents (experimental arms) and isatuximab (Ctrough)","definition_or_measurement_approach":"Pharmacokinetic measurement (Ctrough) of novel agents and isatuximab."}
• {"endpoint_text":"- Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)","definition_or_measurement_approach":"Health-related quality of life assessed using EORTC QLQ-C30 instrument."}
• {"endpoint_text":"- Disease- and treatment-related quality of life will be assessed using the EORTC multiple myeloma module (QLQ-MY20) questionnaire","definition_or_measurement_approach":"Disease- and treatment-related QoL assessed using EORTC QLQ-MY20 module."}
• {"endpoint_text":"- Global impact of side effects will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) (GP5)","definition_or_measurement_approach":"Global impact of side effects assessed using FACT-G (GP5)."}
• {"endpoint_text":"- Estimate/Confirm established clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales","definition_or_measurement_approach":"Assessment of clinically meaningful change scores using PGIS and PGIC scales."}
• {"endpoint_text":"- To assess patient-reported visual functioning for experimental arm only (Substudy 03)","definition_or_measurement_approach":"Patient-reported visual functioning assessed for experimental arm (Substudy 03) using specified PRO instruments."}

Greece

Latest Decision Or Authorization Date

22-01-2026

Number Of Sites

1

Number Of Participants

1

Italy

Latest Decision Or Authorization Date

13-05-2025

Number Of Sites

1

Number Of Participants

1

Norway

Latest Decision Or Authorization Date

16-05-2025

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Endpoint Clinical Inc.

Responsibilities

code 3

Name

Syneos Health Inc.

Responsibilities

code 4

Third parties

• {"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","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"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code 15, sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Australia","full_name":"Cellcarta Pty Limited","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 Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"code 15, Centralized 24-Hour Emergency System","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"code 15, sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}