For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 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

  1. 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.
  2. Participants with serum free light chain (FLC) measurable disease only.
  3. Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.
  4. Participants with inadequate biological tests.
  5. 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%.
  6. Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
  7. Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
  8. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Plasma Cell Myeloma

Age

18+

Phase

Phase 3

Participants needed

302

Est. Completion Date

Apr 2024

Treatment type

Interventional


Sponsor

Sanofi

ClinicalTrials.gov identifier

NCT03275285

Study number

EFC15246

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