Maris 2022: Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) da carfilzomib (Kyprolis, Amgen, Inc.) da dexamethasone sun amince da Hukumar Abinci da Magunguna don manya marasa lafiya tare da relapsed ko refractory mahara myeloma wadanda suka samu 1 zuwa 3 kafin layukan far.
PLEIADES (NCT03412565), ƙungiyoyi masu yawa, gwaji na buɗaɗɗen lakabi, an yi amfani da su don tantance inganci a cikin ƙungiyar hannu guda ɗaya. Mutane 66 da suka sake dawowa ko kuma mai yawa myeloma waɗanda suka sha aƙalla layin jiyya guda ɗaya sun haɗa a cikin wannan binciken. Darzalex Faspro 1,800 mg/30,000 raka'a (1,800 MG daratumumab da 30,000 hyaluronidase raka'a) an ba da subcutaneously a hade tare da Kyprolis (20/70 mg/m2 sau ɗaya tsarin mako-mako) da dexamethasone ga marasa lafiya.
Matsakaicin ƙimar amsa gabaɗaya shine ma'aunin sakamako na farko (ORR). ORR na wannan binciken shine 84.8 bisa dari (95 bisa dari CI: 73.9 bisa dari, kashi 92.5). Ba a kai ga tsawon lokacin amsawa ba a tsaka-tsakin tsaka-tsakin watanni na 9.2, amma an kiyasta 85.2 bisa dari (95 bisa dari CI: 72.5, 92.3) ya ci gaba da mayar da martani ga akalla watanni 6 da 82.5 bisa dari (95 bisa dari CI: 68.9, 90.6) mayar da martani ga akalla watanni 9.
Kwayoyin cututtuka na numfashi na sama, gajiya, rashin barci, hauhawar jini, zawo, tari, dyspnea, ciwon kai, pyrexia, tashin zuciya, da kuma gefen edoema sune abubuwan da suka fi dacewa (20%) a cikin marasa lafiya da aka yi wa Darzalex Faspro, Kyprolis, da dexamethasone.
Darzalex Faspro ana gudanar da shi ta hanyar subcutaneously a kashi na 1,800 mg/30,000 (1,800 mg daratumumab da 30,000 raka'a hyaluronidase) sau ɗaya a mako daga makonni 1 zuwa 8, sau ɗaya kowane mako 2 daga makonni 9 zuwa 24, kuma sau ɗaya kowane mako 4 har zuwa mako 25. ci gaban cuta ko rashin haƙuri mai guba.
Shawarwarin tsarin sashi na Kyprolis lokacin gudanarwa tare da Darzalex Faspro sune kamar haka:
- Sau ɗaya a mako 20/70 mg / m2 tsarin: Kyprolis 20 mg / m2 ana gudanar da shi ta hanyar jiko na IV akan 30 mintuna akan Zagayowar 1 Day 1 kuma idan an jure kashi na 20 mg / m2, 70 mg / m2 azaman jiko na 30-minti IV. akan Zagayowar 1, Ranar 8 da Rana ta 15, sannan Rana ta 1, 8, da 15 na kowane zagayowar kwanaki 28.
- Sau biyu a mako na 20/56 mg / m2 tsarin: Kyprolis 20 mg / m2 ana gudanar da shi ta hanyar jiko na IV akan minti 30 akan Cycle 1 Day 1 da Day 2 kuma, idan an jure kashi na 20 mg / m2, 56 mg / m2 ana gudanarwa ta IV. jiko sama da mintuna 30 akan Zagayowar 1, Rana ta 8, 9, 15, da 16, sannan a ranar 1, 2, 8, 9, 15, 16 na kowane zagayowar kwanaki 28.
CAR T-Cell far yana daga cikin sabbin hanyoyin samun nasara a cikin maganin myeloma da yawa. Ƙara sani game da CAR T-Cell far nan.
