Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Isatuximab SC-OBDS
Isatuximab-OBDS · 1 trial · 1 indication
ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.
| Arm | Type | Description |
|---|---|---|
| Isatuximab in combination with weekly carfilzomib and dexamethasone | EXPERIMENTAL | Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days. |
| Name | Type | Description |
|---|---|---|
| Isatuximab SC-OBDS | DRUG | Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS |
| Montelukast | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:Oral |
| Dexamethasone | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV |
| Acetaminophen | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV |
| Diphenhydramine | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction) |
| Methylprednisolone | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:IV |
| Carfilzomib | DRUG | Pharmaceutical form:As per local commercial product-Route of administration:IV |
Inclusion Criteria: * Participants must have a documented diagnosis of MM. * Participants with measurable disease defined as at least one of the following: * Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M-protein ≥200 mg/24 hours measured using ur...
Isatuximab-OBDS is an investigational antibody being studied for the treatment of refractory plasma cell myeloma, also known as relapsed and/or refractory multiple myeloma. It is administered subcutaneously in combination with weekly carfilzomib and dexamethasone. The drug is currently in Phase 2 clinical development and is not yet approved.
Isatuximab-OBDS is a monoclonal antibody, classified under the -mab target class. It is designed to target CD38, a protein commonly expressed on multiple myeloma cells. By binding to CD38, the antibody aims to help the immune system attack and destroy cancer cells. This mechanism is being evaluated in the ongoing clinical trial.
Isatuximab-OBDS is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this subcutaneous formulation of isatuximab in combination with other therapies for patients with relapsed or refractory multiple myeloma.
Isatuximab-OBDS is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for commercial use. The ongoing Phase 2 trial is actively recruiting participants to assess the drug's effectiveness and safety in treating refractory plasma cell myeloma.
Isatuximab-OBDS is being studied in one active clinical trial, identified as NCT06356571. This Phase 2 study is investigating subcutaneous isatuximab in combination with weekly carfilzomib and dexamethasone in adult participants with relapsed and/or refractory multiple myeloma. The trial is recruiting 64 participants in the United States.
Yes, Isatuximab-OBDS is also known as Isatuximab SC-OBDS. The 'SC' in the alternative name refers to subcutaneous administration, which is the route of delivery being studied in the clinical trial. Both names refer to the same investigational drug developed by Sanofi for the treatment of refractory multiple myeloma.