Therapy Detail
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| Therapy Name | Dexamethasone + Isatuximab + Lenalidomide |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Dexamethasone | Adexone | Desametasone | ||
| Isatuximab | Sarclisa | SAR650984|isatuximab-irfc | CD38 Antibody 20 | Sarclisa (isatuximab-irfc) is a humanized monoclonal antibody against CD38 that induces anti-tumor immune reaction against CD38-positive tumor cells (PMID: 24987056). Sarclisa (isatuximab-irfc) in combination with Pomalyst (pomalidomide) and dexamethasone is FDA approved for use in patients with multiple myeloma who have received two or more prior therapies, in combination with Kyprolis (carfilzomib) and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone for patients with newly diagnosed multiple myeloma ineligible for transplant (FDA.gov). |
| Lenalidomide | Revlimid | IMiD-1 | Revlimid (lenalidomide) is a thalidomide analog which regulates cytokine production and stimulates T cells and NK cells activity (PMID: 24328678). Revlimid (lenalidomide) is FDA approved for use in multiple myeloma, relapsed or refractory Mantle cell lymphoma, and in combination with a rituximab product in follicular lymphoma and marginal zone lymphoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04270409 | Phase III | Dexamethasone + Lenalidomide Dexamethasone + Isatuximab + Lenalidomide | Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma | Active, not recruiting | USA | TUR | SWE | POL | NZL | NOR | LTU | ITA | ISR | IRL | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | AUS | 3 |
| NCT04751877 | Phase III | Dexamethasone + Isatuximab + Lenalidomide Bortezomib + Dexamethasone + Isatuximab + Lenalidomide | Study of Isatuximab+Lenalidomide+Dexamethasone With/Without Bortezomib in de Novo Non Frail NTE Multiple Myeloma Elderly Patients (IFM2020-05) | Active, not recruiting | FRA | 0 |
| NCT05690984 | Phase II | Dexamethasone + Isatuximab + Lenalidomide | Elimination of Minimal Residual Disease After Transplant (EMAT) | Recruiting | USA | 0 |
| NCT03319667 | Phase III | Bortezomib + Dexamethasone + Lenalidomide Dexamethasone + Isatuximab + Lenalidomide Bortezomib + Dexamethasone + Isatuximab + Lenalidomide | Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant (IMROZ) | Active, not recruiting | USA | TUR | SWE | POL | NZL | LTU | ITA | GRC | FRA | ESP | DNK | DEU | CZE | BEL | AUS | 6 |
| NCT04891809 | Phase II | Dexamethasone + Isatuximab + Lenalidomide Dexamethasone + Lenalidomide | Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged >=70 Years) With NDMM | Recruiting | GRC | AUT | 1 |
| NCT05145400 | Phase II | Dexamethasone + Isatuximab + Lenalidomide | Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma | Recruiting | USA | 0 |
| NCT06517017 | Phase II | Dexamethasone + Isatuximab + Lenalidomide | Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma (UltraFrailMM) | Not yet recruiting | USA | 0 |
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