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NCT03275285CompletedPhase 3

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

Source: ClinicalTrials.gov · Last updated 9 Feb 2026

Brief summary (registry, in English)

The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
302 (actual)
First submitted
5 Sept 2017
Start date
25 Oct 2017
Primary completion date
14 Jan 2022
Lead sponsor
Sanofi
NCT number
NCT03275285
EudraCT number
2017-001940-37

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 302
  • From 25 Oct 2017 to the primary completion date, 14 Jan 2022
  • 70 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Lab values

  • Participants with serum free light chain (FLC) measurable disease only.
  • 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%.

Age

  • Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.

Other

  • Participants with inadequate biological tests.
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (70)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Investigational Site Number : 0360005
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BlacktownAustraliaUnknown status
Investigational Site Number : 0360001
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FitzroyAustraliaUnknown status
Investigational Site Number : 0360004
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Heidelberg WestAustraliaUnknown status
Investigational Site Number : 0360007
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NedlandsAustraliaUnknown status
Investigational Site Number : 0360006
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Tweed HeadsAustraliaUnknown status
Investigational Site Number : 0360008
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West PerthAustraliaUnknown status
Investigational Site Number : 0360002
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WollongongAustraliaUnknown status
Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001
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BarretosBrazilUnknown status
Hospital Mae de Deus- Site Number : 0760003
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Porto AlegreBrazilUnknown status
Instituto COI de Educacao e Pesquisa Site Number : 0760004
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Rio de JaneiroBrazilUnknown status
Hospital Sao Rafael - Rede D'OR Sao Luiz Site Number : 0760005
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SalvadorBrazilUnknown status
Hospital das Clinicas de Sao Paulo Site Number : 0760002
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São PauloBrazilUnknown status
Investigational Site Number : 1240002
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MontrealCanadaUnknown status
Investigational Site Number : 1240001
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Saint JohnCanadaUnknown status
Investigational Site Number : 1240003
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SurreyCanadaUnknown status
Investigational Site Number : 2030002
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BrnoCzechiaUnknown status
Investigational Site Number : 2030004
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OlomoucCzechiaUnknown status
Investigational Site Number : 2030003
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Ostrava - PorubaCzechiaUnknown status
Investigational Site Number : 2030001
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PragueCzechiaUnknown status
Investigational Site Number : 7240001
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BadalonaSpainUnknown status
Investigational Site Number : 7240005
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BarcelonaSpainUnknown status
Investigational Site Number : 7240003
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MadridSpainUnknown status
Investigational Site Number : 7240004
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SevilleSpainUnknown status
Investigational Site Number :7240002
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ValenciaSpainUnknown status
Investigational Site Number :2500003
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LilleFranceUnknown status
Investigational Site Number : 2500001
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NantesFranceUnknown status
Investigational Site Number : 2500006
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ParisFranceUnknown status
Investigational Site Number : 2500002
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PessacFranceUnknown status
Investigational Site Number : 2500005
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Pierre-BéniteFranceUnknown status
Investigational Site Number : 2500004
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PoitiersFranceUnknown status
Investigational Site Number : 8260001
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BristolUnited KingdomUnknown status
Investigational Site Number : 8260005
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LeicesterUnited KingdomUnknown status
Investigational Site Number : 8260004
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PlymouthUnited KingdomUnknown status
Investigational Site Number : 3000001
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AthensGreeceUnknown status
Investigational Site Number : 3000005
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AthensGreeceUnknown status
Investigational Site Number : 3000002
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AthensGreeceUnknown status
Investigational Site Number : 3000004
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PátraiGreeceUnknown status
Investigational Site Number :3000003
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ThessalonikiGreeceUnknown status
Investigational Site Number :3480003
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BudapestHungaryUnknown status
Investigational Site Number : 3480004
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BudapestHungaryUnknown status
Investigational Site Number :3480001
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BudapestHungaryUnknown status
Investigational Site Number : 3480005
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KaposvárHungaryUnknown status
Investigational Site Number :3800003
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BolognaItalyUnknown status
Investigational Site Number : 3800001
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PisaItalyUnknown status
Investigational Site Number : 3800004
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Reggio EmiliaItalyUnknown status
Investigational Site Number : 3800002
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TorinoItalyUnknown status
Investigational Site Number : 3920007
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KumamotoJapanUnknown status
Investigational Site Number : 3920004
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Shibuya-kuJapanUnknown status
Investigational Site Number : 3920006
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Shinjuku-kuJapanUnknown status
Investigational Site Number : 3920005
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Shiwa-gunJapanUnknown status
Investigational Site Number : 3920003
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Sunto-gunJapanUnknown status
Investigational Site Number : 3920001
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Suwa-shiJapanUnknown status
Investigational Site Number : 3920002
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YamagataJapanUnknown status
Investigational Site Number : 4100006
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BusanSouth KoreaUnknown status
Investigational Site Number : 4100002
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Gangnam-guSouth KoreaUnknown status
Investigational Site Number : 4100004
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100001
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SeoulSouth KoreaUnknown status
Investigational Site Number : 4100005
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SeoulSouth KoreaUnknown status
Investigational Site Number : 5540001
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AucklandNew ZealandUnknown status
Investigational Site Number : 5540002
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WellingtonNew ZealandUnknown status
Investigational Site Number : 6430003
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KirovRussiaUnknown status
Investigational Site Number : 6430004
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NovosibirskRussiaUnknown status
Investigational Site Number : 6430002
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YekaterinburgRussiaUnknown status
UCSF MS Center Site Number : 8400002
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San FranciscoUnited StatesUnknown status
Spartanburg Medical Center Site Number : 8400003
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SpartanburgUnited StatesUnknown status
Investigational Site Number : 7920003
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AdanaTurkey (Türkiye)Unknown status
Investigational Site Number : 7920001
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AnkaraTurkey (Türkiye)Unknown status
Investigational Site Number : 7920005
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BursaTurkey (Türkiye)Unknown status
Investigational Site Number : 7920002
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920004
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SamsunTurkey (Türkiye)Unknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.