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Isatuximab-Irfc/ML · 1 trial · 1 indication
To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in changing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM).
| Arm | Type | Description |
|---|---|---|
| IRd followed by IR | EXPERIMENTAL | Induction: 8 cycles isatuximab+lenalidomide+dexamethasone; Maintenance: up to 24 cylces isatuximab+lenalidomide |
| Rd followed by R | OTHER | Induction: 8 cycles lenalidomide+dexamethasone; Maintenance: up to 24 cylces lenalidomide |
| Name | Type | Description |
|---|---|---|
| Isatuximab-Irfc 20 MG/ML [Sarclisa] | DRUG | Induction: 10mg/kg on day 1,8,15,22 in cycle 1, subsequently on day 1, 15; every 28 days (q28 days) Maintenance: 10mg/kg, day1, q28 days until progression or intolerance but for a maximum of 24 cycles from start of maintenance |
| Lenalidomide | DRUG | Induction: 25mg\*, day 1-21, every 28 days (q28 days); Maintenance: 5-10mg, day 1-21, q28 days (according to individual tolerance) until progression or intolerance but for a maximum of 24 cycles from start of maintenance \*) for patients with moderate renal impairment (30≤ GFR (MDRD formula) \< 50 mL/min) starting dose is 10 mg |
| Dexamethasone Oral | DRUG | Induction: Patients aged \<75 years: 40mg, once weekly; Patients aged ≥75 years: 20mg, once weekly |
Inclusion Criteria: * Age ≥ 70 years * Able to provide written informed consent in accordance with federal, local, and institutional guidelines * Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization) ...
Isatuximab-Irfc/ML is an investigational drug being studied for the treatment of newly diagnosed multiple myeloma (NDMM). It is currently in Phase 2 clinical development, specifically evaluated in elderly patients aged 70 years and older. The drug is being tested in combination with lenalidomide and dexamethasone (Rd) compared to Rd alone.
Isatuximab-Irfc/ML targets CD38, a cell surface protein highly expressed on multiple myeloma cells. By binding to CD38, the drug is designed to induce immune-mediated cell death of tumor cells. This mechanism is being investigated in the context of newly diagnosed multiple myeloma in a Phase 2 clinical trial.
Isatuximab-Irfc/ML is 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 drug's safety and efficacy in patients with newly diagnosed multiple myeloma.
Isatuximab-Irfc/ML is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, and it is studying the drug in elderly patients with newly diagnosed multiple myeloma.
Isatuximab-Irfc/ML is being studied in one Phase 2 clinical trial with the identifier NCT04891809. This trial is comparing isatuximab in combination with lenalidomide and dexamethasone (Rd) versus Rd alone in elderly patients aged 70 years and older with newly diagnosed multiple myeloma. The trial is active but not recruiting, with an enrollment of 198 participants.
Yes, Isatuximab-Irfc/ML is also known as Isatuximab-Irfc 20 MG/ML [Sarclisa]. Sarclisa is the brand name for isatuximab, a CD38-directed monoclonal antibody. In this context, the drug is being investigated for newly diagnosed multiple myeloma in a Phase 2 clinical trial.