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

ID: NCT03275285
Status: Recruiting
Phase: Phase 3
Start Date: October 19, 2017
First Submitted: September 05, 2017
Last Updated: February 08, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators:
Location: N/A
Conditions:
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Study Description

Brief Summary

Primary Objective:

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.

Secondary Objectives:

- 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 IMWG criteria.

- 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.

Detailed Description

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 survival.
Condition or disease Intervention/treatment Phase
Phase 3

Tracking Information

First Submitted DateSeptember 05, 2017
Last Update Posted DateFebruary 08, 2018
Actual Start DateOctober 19, 2017
Anticipated Completion DateNovember 01, 2023
Actual Primary Completion DateNovember 01, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleMultinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
Official TitleRandomized, 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
Brief Summary

Primary Objective:

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.

Secondary Objectives:

- 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 IMWG criteria.

- 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.

Detailed Description

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 survival.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
Allocation
Interventional Model
Masking
Primary Purpose
Conditions
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment300
Completion DateNovember 01, 2023
Eligibility Criteria: Inclusion criteria:
- Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).
Exclusion criteria:
- Patients 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.
- 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03275285
Other Study ID Numbers
Has Data Monitoring CommitteeYes
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
Not Available
Responsible Party,
Study Sponsor
Not Available
Collaborators
Not Available
Investigators
Not Available