Sanofi
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. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery method of SC isatuximab.
Relapsed/Refractory Multiple Myeloma
Isatuximab
Carfilzomib
Dexamethasone
Dexamethasone IV
Phase 2
The duration of the study for a participant will include a period for screening of up to 28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, as well as the study treatment is commercially available and reimbursed in the participant's country, or is available from another source, whichever is first. The overall study duration will be of approximately 45 months.
Study Type : | Interventional |
Estimated Enrollment : | 68 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | April 5, 2023 |
Estimated Primary Completion Date : | July 17, 2024 |
Estimated Study Completion Date : | November 20, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1: manual administration Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter. |
Drug: Isatuximab Drug: Carfilzomib Drug: Dexamethasone Drug: Dexamethasone IV |
Experimental: Part 1 Cohort 2: manual administration Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter. |
Drug: Isatuximab Drug: Carfilzomib Drug: Dexamethasone Drug: Dexamethasone IV |
Experimental: Part 2 Randomized Cohort: OBDS to manual Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration. |
Drug: Isatuximab Drug: Carfilzomib Drug: Dexamethasone Drug: Dexamethasone IV |
Experimental: Part 2 Randomized Cohort: Manual to OBDS Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration. |
Drug: Isatuximab Drug: Carfilzomib Drug: Dexamethasone Drug: Dexamethasone IV |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Investigational Site Number : 0360002
Wollongong, New South Wales, Australia, 2500
Recruiting
Investigational Site Number : 0360001
Fitzroy, Victoria, Australia, 3065
Recruiting
Hospital Mae de Deus Site Number : 0760002
Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
Recruiting
Clínica São Germano Site Number : 0760003
Sao Paulo, São Paulo, Brazil, 04537-081
Recruiting
Hospital das Clinicas de Sao Paulo Site Number : 0760001
Sao Paulo, São Paulo, Brazil, 05403-000
Recruiting
Investigational Site Number : 2030002
Brno, Chiba, Czechia, 62500
Recruiting
Investigational Site Number : 2030004
Olomouc, Okayama, Czechia, 77900
Recruiting
Investigational Site Number : 2030003
Ostrava - Poruba, Czechia, 70852
Recruiting
Investigational Site Number : 2030001
Praha 2, Czechia, 12808
Recruiting
Investigational Site Number : 3000001
Athens, Greece, 10676
Recruiting
Investigational Site Number : 3000002
Athens, Greece, 11528
Recruiting
Investigational Site Number : 3000003
Thessaloniki, Greece, 54007
Recruiting
Investigational Site Number : 3920001
Kashiwa-shi, Japan, 277-8577
Recruiting
Investigational Site Number : 3920002
Okayama-shi, Japan, 701-1192
Recruiting
Investigational Site Number : 6200001
Braga, Portugal, 4710-243
Recruiting
Investigational Site Number : 6200004
Lisboa, Portugal, 1400-038
Recruiting
Investigational Site Number : 6200005
Lisboa, Portugal, 1649-035