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

Phase 1

• Conditions: Plasma cell myeloma; MedDRA version: 21.1Level: PTClassification code 10035226Term: Plasma cell myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001940-37-GB
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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

-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 serum free light chain (FLC) measurable disease only.
-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, sever/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 (AIDS) or human immunodeficiency virus (HIV) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified