Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04891809 | Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM | PHASE2 | ACTIVE NOT_RECRUITING | 198 | — | — | Oct 20, 2021 | Dec 1, 2028 | Apr 10, 2025 | 14 | Austria, Greece +1 |
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) ...