for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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.

Official Title

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


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.


Plasma Cell Myeloma, Anti-CD38 monoclonal antibody, Multiple Myeloma, Plasma Cell Neoplasms, Dexamethasone, isatuximab SAR650984, carfilzomib, Isatuximab + Carfilzomib + Dexamethasone (IKd), Carfilzomib + Dexamethasone (Kd)


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.


  • UCSF MS Center Site Number : 8400002
    San Francisco California 94117 United States
  • Investigational Site Number : 1240003
    Surrey British Columbia V3V 1Z2 Canada


in progress, not accepting new patients
Start Date
Completion Date
Phase 3 Multiple Myeloma Research Study
Study Type
About 302 people participating
Last Updated