Multiple Myeloma Clinical Trial
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Summary
Primary Objective:
To demonstrate the benefit of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.
Secondary Objectives:
To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR) or better and complete response (CR) rate in both arms using International Myeloma Working Group (IMWG) criteria.
To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
To evaluate the Overall Survival (OS) in both arms.
To evaluate safety in both arms.
To evaluate duration of response (DOR) in both arms.
To evaluate the Time To Progression (TTP) in both arms.
To evaluate the Second Progression Free Survival (PFS2) in both arms.
To evaluate the Time to first response
To evaluate the Time to best response
To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
To evaluate the immunogenicity of isatuximab in isatuximab arm.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.
Full Description
The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.
Eligibility Criteria
Inclusion criteria:
Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24 hours).
Exclusion criteria:
Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
Participants with serum free light chain (FLC) measurable disease only.
Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.
Participants with inadequate biological tests.
Participants with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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There are 70 Locations for this study
San Francisco California, 94117, United States
Spartanburg South Carolina, 29303, United States
Blacktown New South Wales, 2148, Australia
Tweed Heads New South Wales, 2485, Australia
Wollongong New South Wales, 2500, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg West Victoria, 3081, Australia
Nedlands Western Australia, 6009, Australia
West Perth Western Australia, 6005, Australia
Salvador Bahia, 41253, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Barretos São Paulo, 14784, Brazil
Sao Paulo São Paulo, 05403, Brazil
Rio De Janeiro , 22775, Brazil
Surrey British Columbia, V3V 1, Canada
Saint John New Brunswick, E2L 4, Canada
Montreal Quebec, H1T 2, Canada
Brno , 62500, Czechia
Olomouc , 77900, Czechia
Ostrava - Poruba , 70852, Czechia
Praha 2 , 12808, Czechia
Lille , 59037, France
Nantes , 44093, France
Paris , 75012, France
Pessac , 33600, France
Pierre Benite , 69495, France
POITIERS Cedex , 86021, France
Athens , 10676, Greece
Athens , 11527, Greece
Athens , 11528, Greece
Patra , 26504, Greece
Thessaloniki , 57010, Greece
Budapest , 1083, Hungary
Budapest , 1097, Hungary
Budapest , 1125, Hungary
Kaposvár , 7400, Hungary
Bologna , 40138, Italy
Pisa , 56126, Italy
Reggio Emilia , 42123, Italy
Torino , 10126, Italy
Shiwa-gun Iwate, 028-3, Japan
Kumamoto-shi Kumamoto, 860-8, Japan
Suwa-shi Nagano, 392-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Shinjuku-ku Tokyo, 162-8, Japan
Yamagata-shi , 990-9, Japan
Gangnam-gu Seoul-teukbyeolsi, 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Seoul Seoul-teukbyeolsi, 06591, Korea, Republic of
Busan , 602-7, Korea, Republic of
Auckland , 1640, New Zealand
Wellington , 6021, New Zealand
Ekaterinburg , 62010, Russian Federation
Kirov , 61002, Russian Federation
Novosibirsk , 63004, Russian Federation
Badalona Catalunya [Cataluña], 08916, Spain
Barcelona Catalunya [Cataluña], 08036, Spain
Valencia Valenciana, Comunidad, 46017, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Adana , 01250, Turkey
Ankara , 06500, Turkey
Bursa , 16059, Turkey
Istanbul , 34381, Turkey
Samsun , 55139, Turkey
Plymouth Devon, PL6 8, United Kingdom
Leicester Leicestershire, LE1 5, United Kingdom
Bristol Somerset, BS2 8, United Kingdom
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