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

NCT03275285

CompletedPhase 3

Sponsor: Sanofi

Conditions: Plasma Cell Myeloma

Interventions: isatuximab SAR650984, carfilzomib, dexamethasone

Countries: United States, Australia, Brazil, Canada, Czechia, France, Greece, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (70)
  • San Francisco, California, United States
  • Spartanburg, South Carolina, United States
  • Blacktown, New South Wales, Australia
  • Tweed Heads, New South Wales, Australia
  • Wollongong, New South Wales, Australia
  • Fitzroy, Victoria, Australia
  • Heidelberg West, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • West Perth, Western Australia, Australia
  • Salvador, Estado de Bahia, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • Surrey, British Columbia, Canada
  • Saint John, New Brunswick, Canada
  • Montreal, Quebec, Canada
  • Brno, Czechia
  • Olomouc, Czechia
  • Ostrava - Poruba, Czechia
  • Prague, Czechia
  • Lille, France
  • Nantes, France
  • Paris, France
  • Pessac, France
  • Pierre-Bénite, France
  • Poitiers, France
  • Athens, Greece
  • Athens, Greece
  • Athens, Greece
  • + 40 more on CT.gov