March 2022: I-Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) kanye ne-carfilzomib (Kyprolis, Amgen, Inc.) kanye ne-dexamethasone kugunyazwe i-Food and Drug Administration ezigulini ezikhulile ezine-myeloma eminingi ebuyele emuva noma ephikisayo ezithole i-1 kuya 3 imigqa yangaphambili yokwelapha.
I-PLEIADES (NCT03412565), isivivinyo samaqoqo amaningi, ilebula evulekile, sasetshenziselwa ukuhlola ukusebenza kahle kweqembu lengalo eyodwa. Abantu abangu-66 abane-myeloma eminingi ebuyele emuva noma ephikisayo abaye babhekana okungenani nomugqa owodwa wokwelapha wangaphambili bafakiwe kulolu cwaningo. I-Darzalex Faspro 1,800 mg/30,000 amayunithi (1,800 mg daratumumab kanye namayunithi angama-30,000 e-hyaluronidase) anikezwe ngaphansi kwesikhumba kuhlanganiswe ne-Kyprolis (20/70 mg/m2 kanye ngesonto) kanye ne-dexamethasone ezigulini.
Isilinganiso sokuphendula sisonke bekuyi-primary efficacy result measure (ORR). I-ORR yalolu cwaningo yayingamaphesenti angu-84.8 (amaphesenti angu-95 CI: amaphesenti angu-73.9, amaphesenti angu-92.5). Ubude bempendulo obuphakathi abukafinyelelwa ekulandeleni okuphakathi kwezinyanga ze-9.2, kodwa amaphesenti alinganiselwa ku-85.2 (amaphesenti angu-95 CI: 72.5, 92.3) agcine impendulo okungenani izinyanga ezingu-6 kanye namaphesenti angu-82.5 (amaphesenti angu-95 CI: 68.9, 90.6) igcine impendulo okungenani izinyanga eziyi-9.
Izifo zepheshana lokuphefumula eliphezulu, ukukhathala, ukuqwasha, umfutho wegazi ophakeme, isifo sohudo, ukukhwehlela, i-dyspnea, ikhanda elibuhlungu, i-pyrexia, isicanucanu, kanye ne-edoma peripheral kwakuyizehlakalo eziseceleni ezivame kakhulu (20%) ezigulini ezilashwa nge-Darzalex Faspro, Kyprolis, ne-dexamethasone.
I-Darzalex Faspro iphathwa ngaphansi kwesikhumba ngethamo lamayunithi ayi-1,800 mg/30,000 (1,800 mg daratumumab kanye namayunithi angama-30,000 we-hyaluronidase) kanye ngesonto kusukela emavikini 1 kuya ku-8, kanye njalo emavikini angu-2 kusukela emavikini angu-9 kuya kwangu-24 kuze kube kanye ngeviki le-4 kuya kwangu-25. ukuqhubeka kwesifo noma ubuthi obungabekezeleleki.
Imithi enconyiwe yomthamo we-Kyprolis uma ihlanganiswa ne-Darzalex Faspro yile elandelayo:
- Kanye ngeviki 20/70 mg/m2 irejimeni: Kyprolis 20 mg/m2 elawulwa IV ukumnika phezu 30 imizuzu Cycle 1 Day 1 futhi uma umthamo 20 mg/m2 ibekezelelwa, 70 mg/m2 njengemizuzu 30 IV ukumnika. ku-Cycle 1, Day 8 kanye no-Day 15, bese kuba Usuku 1, 8, no-15 kumjikelezo ngamunye wezinsuku ezingama-28.
- Kabili ngeviki uhlobo lwe-20/56 mg/m2: i-Kyprolis 20 mg/m2 elawulwa ngokufakwa kwe-IV ngaphezu kwemizuzu engama-30 ku-Cycle 1 Day 1 noSuku 2 futhi, uma umthamo we-20 mg/m2 ubekezelelwa, 56 mg/m2 olawulwa yi-IV. ukumnika imizuzu engama-30 ku-Cycle 1, Day 8, 9, 15, no-16, bese kuthi ngoSuku 1, 2, 8, 9, 15, 16 emjikelezweni ngamunye wezinsuku ezingama-28.
CAR T-Cell therapy is among the latest breakthrough therapy in the treatment of i-myeloma eminingi. Know more about CAR T-Cell therapy lapha.
