Spots Global Cancer Trial Database for Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Official Title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
Study ID: NCT03194867
Conditions
Study Description
Brief Summary: Primary Objectives: * To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma. * To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS). * To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination. * To assess the immunogenicity of isatuximab and cemiplimab when given in combination.
Detailed Description: The duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. The cycle duration is 28 days. Patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado-Site Number:8400001, Denver, Colorado, United States
University of Kansas Medical Center-Site Number:8400003, Kansas City, Kansas, United States
Memorial Sloan-Kettering Cancer Center-Site Number:8400002, New York, New York, United States
Fox Chase Cancer Center-Site Number:8400004, Philadelphia, Pennsylvania, United States
Investigational Site Number :0360003, Wollongong, New South Wales, Australia
Investigational Site Number :0360002, Richmond, Victoria, Australia
Investigational Site Number :0360001, West Perth, Western Australia, Australia
Investigational Site Number :0760003, Goiania, Goiás, Brazil
Investigational Site Number :0760001, Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760004, Sao Paulo, São Paulo, Brazil
Investigational Site Number :1240001, Montreal, Quebec, Canada
Investigational Site Number :1240005, Montreal, Quebec, Canada
Investigational Site Number :1240003, Sherbrooke, Quebec, Canada
Investigational Site Number :2030002, Brno, , Czechia
Investigational Site Number :2030003, Ostrava - Poruba, , Czechia
Investigational Site Number :2030001, Praha 2, , Czechia
Investigational Site Number :2500004, Lille, , France
Investigational Site Number :2500002, Nantes, , France
Investigational Site Number :2500003, Pierre Benite, , France
Investigational Site Number :2500001, Villejuif, , France
Investigational Site Number :3000001, Athens, , Greece
Investigational Site Number :3480002, Budapest, , Hungary
Investigational Site Number :3800005, Rozzano, Milano, Italy
Investigational Site Number :3800003, Brescia, , Italy
Investigational Site Number :3800001, Torino, , Italy
Investigational Site Number :7240003, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240004, Badalona, Catalunya [Cataluña], Spain
Investigational Site Number :7240002, Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number :7240005, Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240006, Madrid, , Spain
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
