Therapy Detail
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| Therapy Name | Ciltacabtagene autoleucel + Cyclophosphamide + Daratumumab + Dexamethasone + Fludarabine + Pomalidomide |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ciltacabtagene autoleucel | Carvykti | JNJ-68284528|JNJ-4528|Cilta-cel | Carvykti (ciltacabtagene autoleucel) is a chimeric antigen receptor T (CAR T)-cell therapy targeting B-cell maturation antigen (BCMA) that may induce cytotoxic immune response against BCMA-expressing tumor cells (PMID: 31622496, PMID: 34175021). Carvykti (ciltacabtagene autoleucel) is FDA approved for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy (FDA.gov). | |
| Cyclophosphamide | Cytoxan | CPM | Chemotherapy - Alkylating 18 | Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary). |
| Daratumumab | Darzalex | JNJ-54767414 | CD38 Antibody 20 | Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (FDA.gov). |
| Dexamethasone | Adexone | Desametasone | ||
| Fludarabine | Fludara | FAMP|Fludarabine phosphate | Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary) | |
| Pomalidomide | Pomalyst | CC-4047 | Pomalyst (pomalidomide) is a thalidomide derivative that inhibits angiogenesis and modulates immune response, potentially lead to antitumor activity (PMID: 30069630). Pomalyst (pomalidomide) is FDA approved for use in patients with Kaposi's sarcoma who failed HAART or are HIV-negative, and in combination with dexamethasone in patients with multiple myeloma who had 2 or more prior therapies (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 |
|---|---|---|---|---|---|---|
| NCT04181827 | Phase III | Daratumumab + Dexamethasone + Pomalidomide Bortezomib + Dexamethasone + Pomalidomide Bortezomib + Ciltacabtagene autoleucel + Cyclophosphamide + Dexamethasone + Fludarabine + Pomalidomide Ciltacabtagene autoleucel + Cyclophosphamide + Daratumumab + Dexamethasone + Fludarabine + Pomalidomide | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4) | Active, not recruiting | USA | SWE | POL | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DNK | DEU | BEL | AUS | 2 |
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