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

Completed · Phase 3

Conditions studied: Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT03275285

Run by

Sanofi

People needed

302

Starts

2017-10-25

Expected to finish

2025-01-03

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Spartanburg Medical Center Site Number : 8400003 — Spartanburg, South Carolina, United States
• Investigational Site Number : 0360005 — Blacktown, New South Wales, Australia
• Investigational Site Number : 0360006 — Tweed Heads, New South Wales, Australia
• Investigational Site Number : 0360002 — Wollongong, New South Wales, Australia
• Investigational Site Number : 0360001 — Fitzroy, Victoria, Australia
• Investigational Site Number : 0360004 — Heidelberg West, Victoria, Australia
• Investigational Site Number : 0360007 — Nedlands, Western Australia, Australia
• Investigational Site Number : 0360008 — West Perth, Western Australia, Australia
• Hospital Sao Rafael - Rede D'OR Sao Luiz Site Number : 0760005 — Salvador, Estado de Bahia, Brazil
• Hospital Mae de Deus Site Number : 0760003 — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001 — Barretos, São Paulo, Brazil
• Hospital das Clinicas de Sao Paulo Site Number : 0760002 — São Paulo, São Paulo, Brazil
• Instituto COI de Educacao e Pesquisa Site Number : 0760004 — Rio de Janeiro, Brazil
• Investigational Site Number : 1240003 — Surrey, British Columbia, Canada
• Investigational Site Number : 1240001 — Saint John, New Brunswick, Canada
• Investigational Site Number : 1240002 — Montreal, Quebec, Canada
• Investigational Site Number : 2030002 — Brno, Czechia
• Investigational Site Number : 2030004 — Olomouc, Czechia
• Investigational Site Number : 2030003 — Ostrava - Poruba, Czechia
• Investigational Site Number : 2030001 — Prague, Czechia
• Investigational Site Number : 2500003 — Lille, France
• Investigational Site Number : 2500001 — Nantes, France
• Investigational Site Number : 2500006 — Paris, France
• Investigational Site Number : 2500002 — Pessac, France
• UCSF MS Center Site Number : 8400002 — San Francisco, California, United States

Full record on ClinicalTrials.gov

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