Plasma cell myeloma MedDRA version: 21.1 Level: PT Classification code 10035226 Term: Plasma cell myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: -Evaluate the Overall Response Rate, rate of very good partial response (VGPR) or better and complete response rate in both arms using IMWG criteria. -Evaluate rate of VGPR or better with minimal residual disease negativity in both arms using IMWG criteria. -Evaluate the Overall Survival in both arms -Evaluate safety in both arms -Evaluate duration of response in both arms. -Evaluate the Time To Progression in both arms. -Evaluate time from the date of randomization to the date of the second PD or death from any cause, whichever happen first (PFS2) in both arms. -Evaluate time to first response in both arms -Evaluate time to best response in both arms -Determine the PK profile of isatuximab in combination with carfilzomib. -Evaluate the immunogenicity of isatuximab in isatuximab arm. -Assess disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status in both arms.;Primary end point(s): Progression Free Suvival (PFS): The length of time between treatment allocation and a patient lives with the disease but it does not get worse.;Timepoint(s) of evaluation of this end point: up to approximately 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Overall Response Rate (ORR): The proportion of patients that have a response to their disease: stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) 2) Rate of VGPR or better: The proportion of patients with sCR, CR and VGPR 3) CR rate: The proportion of patients with sCR and CR 4) Rate of CR with MRD(Minimal Residual Disease) negativity: The proportion of patients =CR (sCR and CR) and for whom MRD assessed by sequencing is negative. 5) Overall Survival (OS): The length of time from the treatment allocation for a disease that patients are still alive 6) Time to Progression (TTP): How long the study treatment last before disease progression occurs 7) Second Progression Free Survial (PFS2): The length of time between treatment allocation and second progression disease 8) Duration of response (DOR): How long from the first response is observed until disease progression 9) Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria(NCI- CTC) version 4.03 grading scaling: To evaluate how many adverse events occur while taking study treatment 10) Patient-reported outcome measured with Quality of Life questionnaire : To evaluate change in your daily activites from screening 11) Pharmacokinetics of isatuximab: To evaluate the plasma concentration of isatuximab 12) Pharmacokinetics of carfilzomib: To evaluate the plasma concentration of carfilzomib in 12 patients 13) Immunogenicity (ADA): To evaluate if presence of anti-drug antibodies against isatuximab 14) Time to first response: Length of time from treatment allocation to the date of first response (PR or better) 15) Time to best response: Length of time from treatment allocation to the date of first best overall response (PR or better);Timepoint(s) of evaluation of this end point: 1), 2), 3), 4), 6), 7), 8) 14) 15) up to approximately 50 months 5) up to approximately 63 mont | — |
Countries
Australia, Brazil, Canada, Czechia, Czech Republic, France, Greece, Hungary, Italy, Japan, Korea, Republic of, New Zealand, Russian Federation, Spain, Turkey, United Kingdom, United States
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed