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A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Sponsor: Sanofi
Summary
The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.
Official title: A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2023-04-05
Completion Date
2028-05-12
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Isatuximab
Investigational medicinal product; Pharmaceutical form: Solution for Subcutaneous administration; Route of administration: Subcutaneous
Carfilzomib
Investigational medicinal product; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
Dexamethasone
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Tablet; Route of administration: Oral
Dexamethasone IV
Investigational medicinal product/background treatment; ATC code: H02AB02; Pharmaceutical form: Powder for solution for infusion; Route of administration: Intravenous
Montelukast
Background Treatment; ATC code: R03DC03; Pharmaceutical form: As per local commercial product; Route of administration: Oral
Acetaminophen
Background Treatment; ATC code: N02BE01; Pharmaceutical form: As per local commercial product; Route of administration: Oral or intravenous (IV)
Diphenhydramine
Background Treatment; ATC code: R06AA02; Pharmaceutical form: As per local commercial product; Route of administration: Oral or IV
Methylprednisolone
Background Treatment/Rescue medication; ATC code: H02AB04; Pharmaceutical form: As per local commercial product; Route of administration: IV
Locations (23)
Investigational Site Number : 0360002
Wollongong, New South Wales, Australia
Investigational Site Number : 0360001
Melbourne, Victoria, Australia
Hospital Mae de Deus Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Clinica São Germano- Site Number : 0760003
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo, Brazil
Investigational Site Number : 1560006
Changsha, China
Investigational Site Number : 1560002
Guangzhou, China
Investigational Site Number : 1560005
Nanchang, China
Investigational Site Number : 1560004
Shenyang, China
Investigational Site Number : 1560001
Tianjin, China
Investigational Site Number : 1560007
Tianjin, China
Investigational Site Number : 1560003
Wuhan, China
Investigational Site Number : 2030002
Brno, Czechia
Investigational Site Number : 2030004
Olomouc, Czechia
Investigational Site Number : 2030003
Ostrava, Czechia
Investigational Site Number : 2030001
Prague, Czechia
Investigational Site Number : 3000001
Athens, Greece
Investigational Site Number : 3000002
Athens, Greece
Investigational Site Number : 3920001
Kashiwa, Chiba, Japan
Investigational Site Number : 3920002
Okayama, Japan
Investigational Site Number : 6200001
Braga, Portugal
Investigational Site Number : 6200004
Lisbon, Portugal
Investigational Site Number : 6200005
Lisbon, Portugal