To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in
the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and
dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously
treated with 1 to 3 lines of therapy.
- To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR)
or better and complete response (CR) rate in both arms using International Myeloma
Working Group (IMWG) criteria.
- To evaluate rate of CR with minimal residual disease (MRD) negativity in both arms using
- To evaluate the Overall Survival (OS) in both arms.
- To evaluate safety in both arms.
- To evaluate duration of response (DOR) in both arms.
- To evaluate the Time To Progression (TTP) in both arms.
- To evaluate the Second Progression Free Survival (PFS2) in both arms.
- To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
- To evaluate the immunogenicity of isatuximab in isatuximab arm.
- To assess disease-specific and generic health-related quality of life (HRQL), disease
and treatment-related symptoms, health state utility, and health status in both arms.
The duration of the study for the patients will include a period for screening of up to 3
weeks. Patients will continue study treatment until disease progression, unacceptable adverse
reaction, patients' wish or other reason of discontinuation. During follow-up, patients who
discontinue the study treatment due to progression of the disease will be followed every 3
months (12 weeks) for further anti-myeloma therapies, progression free survival to the second
progression and survival, until death or the cut-off date, whichever comes first. Patients
who discontinue the study treatment prior to documentation of disease progression will be
followed-up every 4 weeks until confirmation of disease progression, and then every 3 months
(12 weeks) for further anti-myeloma therapies, progression free survival to the second
progression and survival, until death or the cut-off date, whichever comes first. After
progression free survival analysis, patients will be followed yearly for 3 years for
|Condition or disease
|First Submitted Date||September 05, 2017|
|Last Update Posted Date||February 08, 2018|
|Actual Start Date||October 19, 2017|
|Anticipated Completion Date||November 01, 2023|
|Actual Primary Completion Date||November 01, 2020|
|Results First Submitted Date||N/A|
|Received Results Disposit Date||N/A|
Current Primary Outcome Measures
Original Primary Outcome Measures
Current Secondary Outcome Measures
Original Secondary Outcome Measures
|Brief Title||Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients|
|Official Title||Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (KyprolisÂ®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines|
|Study Phase||Phase 3|
|Target Follow-Up Duration|| N/A|
|Completion Date||November 01, 2023|
- Patients with multiple myeloma previously treated with prior 1 to 3 lines and with
measurable serum M-protein (â‰¥ 0.5 g/dL) and/or urine M-protein (â‰¥ 200 mg/24 hours).
- Patients previously pretreated with carfilzomib, who never achieved at least one minor
response during previous therapies and/or last previous therapy completed within 14
- Patients with only free light measurable.
- Patients less than 18 years old, patients with Eastern Cooperative Oncology Group
performance status more than 2.
- Patients with inadequate biological tests.
- Patients 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%.
- Patients with previous cancer unless disease free for more than 5 years or in situ
cancer curatively treated.
- Patients with known acquired immunodeficiency syndrome related illness or requiring
antiretroviral treatment, or hepatitis A, B, or C active infection.
- Women of childbearing potential or male patient 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 patient's
potential participation in a clinical trial.
|Age||18 Years to N/A|
|Accepts Healthy Volunteers||No|
|Listed Location Countries
|Other Study ID Numbers
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
|IPD Sharing Statement
|Responsible Party||, |