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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

302

Study ID:

NCT03275285

Recruitment Status:

Active, not recruiting

Sponsor:

Sanofi

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There are 70 Locations for this study

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UCSF MS Center Site Number : 8400002
San Francisco California, 94117, United States
Spartanburg Medical Center Site Number : 8400003
Spartanburg South Carolina, 29303, United States
Investigational Site Number : 0360005
Blacktown New South Wales, 2148, Australia
Investigational Site Number : 0360006
Tweed Heads New South Wales, 2485, Australia
Investigational Site Number : 0360002
Wollongong New South Wales, 2500, Australia
Investigational Site Number : 0360001
Fitzroy Victoria, 3065, Australia
Investigational Site Number : 0360004
Heidelberg West Victoria, 3081, Australia
Investigational Site Number : 0360007
Nedlands Western Australia, 6009, Australia
Investigational Site Number : 0360008
West Perth Western Australia, 6005, Australia
Hospital Sao Rafael Site Number : 0760005
Salvador Bahia, 41253, Brazil
Hospital Mae de Deus Site Number : 0760003
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001
Barretos São Paulo, 14784, Brazil
Hospital das Clinicas de Sao Paulo Site Number : 0760002
Sao Paulo São Paulo, 05403, Brazil
Instituto COI de Educacao e Pesquisa Site Number : 0760004
Rio De Janeiro , 22775, Brazil
Investigational Site Number : 1240003
Surrey British Columbia, V3V 1, Canada
Investigational Site Number : 1240001
Saint John New Brunswick, E2L 4, Canada
Investigational Site Number : 1240002
Montreal Quebec, H1T 2, Canada
Investigational Site Number : 2030002
Brno , 62500, Czechia
Investigational Site Number : 2030004
Olomouc , 77900, Czechia
Investigational Site Number : 2030003
Ostrava - Poruba , 70852, Czechia
Investigational Site Number : 2030001
Praha 2 , 12808, Czechia
Investigational Site Number : 2500003
Lille , 59037, France
Investigational Site Number : 2500001
Nantes , 44093, France
Investigational Site Number : 2500006
Paris , 75012, France
Investigational Site Number : 2500002
Pessac , 33600, France
Investigational Site Number : 2500005
Pierre Benite , 69495, France
Investigational Site Number : 2500004
POITIERS Cedex , 86021, France
Investigational Site Number : 3000002
Athens , 10676, Greece
Investigational Site Number : 3000005
Athens , 11527, Greece
Investigational Site Number : 3000001
Athens , 11528, Greece
Investigational Site Number : 3000004
Patra , 26504, Greece
Investigational Site Number : 3000003
Thessaloniki , 57010, Greece
Investigational Site Number : 3480003
Budapest , 1083, Hungary
Investigational Site Number : 3480001
Budapest , 1097, Hungary
Investigational Site Number : 3480004
Budapest , 1125, Hungary
Investigational Site Number : 3480005
Kaposvár , 7400, Hungary
Investigational Site Number : 3800003
Bologna , 40138, Italy
Investigational Site Number : 3800001
Pisa , 56126, Italy
Investigational Site Number : 3800004
Reggio Emilia , 42123, Italy
Investigational Site Number : 3800002
Torino , 10126, Italy
Investigational Site Number : 3920005
Shiwa-gun Iwate, 028-3, Japan
Investigational Site Number : 3920007
Kumamoto-shi Kumamoto, 860-8, Japan
Investigational Site Number : 3920001
Suwa-shi Nagano, 392-8, Japan
Investigational Site Number : 3920003
Sunto-gun Shizuoka, 411-8, Japan
Investigational Site Number : 3920004
Shibuya-ku Tokyo, 150-8, Japan
Investigational Site Number : 3920006
Shinjuku-ku Tokyo, 162-8, Japan
Investigational Site Number : 3920002
Yamagata-shi , 990-9, Japan
Investigational Site Number : 4100002
Gangnam-gu Seoul-teukbyeolsi, 06351, Korea, Republic of
Investigational Site Number : 4100001
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number : 4100004
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Investigational Site Number : 4100005
Seoul Seoul-teukbyeolsi, 06591, Korea, Republic of
Investigational Site Number : 4100006
Busan , 602-7, Korea, Republic of
Investigational Site Number : 5540001
Auckland , 1640, New Zealand
Investigational Site Number : 5540002
Wellington , 6021, New Zealand
Investigational Site Number : 6430002
Ekaterinburg , 62010, Russian Federation
Investigational Site Number : 6430003
Kirov , 61002, Russian Federation
Investigational Site Number : 6430004
Novosibirsk , 63004, Russian Federation
Investigational Site Number : 7240001
Badalona Catalunya [Cataluña], 08916, Spain
Investigational Site Number : 7240005
Barcelona Catalunya [Cataluña], 08036, Spain
Investigational Site Number : 7240002
Valencia Valenciana, Comunidad, 46017, Spain
Investigational Site Number : 7240003
Madrid , 28041, Spain
Investigational Site Number : 7240004
Sevilla , 41013, Spain
Investigational Site Number : 7920003
Adana , 01250, Turkey
Investigational Site Number : 7920001
Ankara , 06500, Turkey
Investigational Site Number : 7920005
Bursa , 16059, Turkey
Investigational Site Number : 7920002
Istanbul , 34381, Turkey
Investigational Site Number : 7920004
Samsun , 55139, Turkey
Investigational Site Number : 8260004
Plymouth Devon, PL6 8, United Kingdom
Investigational Site Number : 8260005
Leicester Leicestershire, LE1 5, United Kingdom
Investigational Site Number : 8260001
Bristol Somerset, BS2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

302

Study ID:

NCT03275285

Recruitment Status:

Active, not recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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