Status:
COMPLETED
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Lead Sponsor:
Sanofi
Conditions:
Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 treat...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2025
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT03275285
Start Date
October 25 2017
End Date
January 3 2025
Last Update
February 4 2025
Active Locations (70)
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1
UCSF MS Center Site Number : 8400002
San Francisco, California, United States, 94117
2
Spartanburg Medical Center Site Number : 8400003
Spartanburg, South Carolina, United States, 29303-3040
3
Investigational Site Number : 0360005
Blacktown, New South Wales, Australia, 2148
4
Investigational Site Number : 0360006
Tweed Heads, New South Wales, Australia, 2485