ISATUXIMAB for Multiple myeloma | Relapsed or refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"-Participant must be 18 years of age inclusive or older."}
• {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) performance status 0-1."}
• {"criterion_text":"-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)."}
• {"criterion_text":"-RRMM with measurable disease: -Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or"}
• {"criterion_text":"-RRMM with measurable disease:-Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or"}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Men or woman or childbearing potential should agree to use contraception."}
• {"criterion_text":"-Substudy 01: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dose. “Exposure” is defined as at least 2 cycles of therapy."}

Exclusion criteria

• {"criterion_text":"-Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma."}
• {"criterion_text":"-Participants with a contraindication to treatment."}
• {"criterion_text":"-Vaccination with a live vaccine 4 weeks before the start of the study."}
• {"criterion_text":"-Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted."}
• {"criterion_text":"-Hemoglobin <8 g/dL."}
• {"criterion_text":"-Platelets <50 × 10^9/L."}
• {"criterion_text":"-Absolute neutrophil count <1.0 × 10^9/L."}
• {"criterion_text":"-Creatinine clearance <30 mL/min/1.73m2"}
• {"criterion_text":"-Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN."}
• {"criterion_text":"-Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN."}
• {"criterion_text":"-Patients with grade 3 or 4 hypercalcemia."}
• {"criterion_text":"-Uncontrolled infection within 14 days prior to first study intervention administration."}
• {"criterion_text":"-Substudy 01:Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide."}
• {"criterion_text":"-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)."}
• {"criterion_text":"-Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A."}
• {"criterion_text":"-Uncontrolled or active hepatitis B virus (HBV) infection."}
• {"criterion_text":"-Active hepatitis C virus (HCV) infection."}
• {"criterion_text":"-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"}
• {"criterion_text":"-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."}
• {"criterion_text":"-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- Master only","definition_or_measurement_approach":"Dose-finding / determination of recommended dose (no further measurement approach specified in the available data)."}
• {"endpoint_text":"-Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)","definition_or_measurement_approach":"Rate of Very Good Partial Response (VGPR) or better (endpoint defined as VGPR rate or better)."}
• {"endpoint_text":"-Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies","definition_or_measurement_approach":"Overall Response Rate (ORR) (no additional measurement approach specified in the available data)."}

Secondary endpoints

• {"endpoint_text":"-Part 1 (dose finding, experimental substudies): ORR – Master only","definition_or_measurement_approach":"Overall Response Rate (ORR) (no additional measurement approach specified)."}
• {"endpoint_text":"-Part 2 (expansion, controlled experimental substudies): ORR","definition_or_measurement_approach":"Overall Response Rate (ORR)."}
• {"endpoint_text":"-Part 1 (dose finding, experimental substudies): VGPR or better – Master only","definition_or_measurement_approach":"VGPR or better."}
• {"endpoint_text":"-Part 2 (expansion, independent experimental substudies): VGPR or better","definition_or_measurement_approach":"VGPR or better."}
• {"endpoint_text":"-Clinical Benefit Rate (CBR) in each treatment arm","definition_or_measurement_approach":"Clinical Benefit Rate (CBR) (no additional measurement approach specified)."}
• {"endpoint_text":"-Duration of Response (DOR) in each treatment arm","definition_or_measurement_approach":"Duration of response (DOR) measured per standard oncology response assessment (no further details provided)."}
• {"endpoint_text":"-Time to First Response (TT1R) in each treatment arm","definition_or_measurement_approach":"Time to first response (TT1R)."}
• {"endpoint_text":"-Time to Best Response (TTBR) in each treatment arm","definition_or_measurement_approach":"Time to best response (TTBR)."}
• {"endpoint_text":"-Number of participants with treatment emergent adverse events and serious adverse events in each treatment arm","definition_or_measurement_approach":"Counts of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per arm."}
• {"endpoint_text":"-Progression-free survival (PFS) in each treatment arm","definition_or_measurement_approach":"Progression-free survival (PFS) (no further details provided)."}
• {"endpoint_text":"-Overall Survival (OS) in each treatment arm","definition_or_measurement_approach":"Overall survival (OS)."}
• {"endpoint_text":"-Immunogenicity of isatuximab and novel agents","definition_or_measurement_approach":"Assessment of potential immunogenicity of isatuximab and novel agents (no assay details provided)."}
• {"endpoint_text":"-Concentration of novel agents (experimental arms) and isatuximab (Ctrough)","definition_or_measurement_approach":"Trough concentration (Ctrough) measurements of isatuximab and novel agents."}
• {"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 questionnaire."}
• {"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-specific HRQL 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 item)."}
• {"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":"Estimation/confirmation of clinically meaningful change scores using PGIS and PGIC scales."}

France

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

477

Number Of Sites

4

Number Of Participants

1

Germany

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

581

Number Of Sites

2

Number Of Participants

1

Greece

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

479

Number Of Sites

2

Number Of Participants

2

Italy

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

478

Number Of Sites

2

Number Of Participants

1

Portugal

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

477

Number Of Sites

2

Number Of Participants

1

Norway

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

480

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

Third parties

• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sample storage (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","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":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"CellCarta Biosciences","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"}
• {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"Cellcarta Pty Limited","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 Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sample storage (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}