Maarso 2022: Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) iyo carfilzomib (Kyprolis, Amgen, Inc.) oo lagu daray dexamethasone ay u ansixiyeen Maamulka Cuntada iyo Dawooyinka ee bukaanada qaangaarka ah ee leh soo noqnoqda ama dib u laabashada myeloma badan kuwaas oo helay 1 ilaa 3 khadadka daawaynta hore.
PLEIADES (NCT03412565), koox-koox badan, tijaabo sumad furan, ayaa loo isticmaalay si loo qiimeeyo waxtarka kooxda hal-gacan. 66 qofood oo leh labakaclayn ama dib u celin badan oo myeloma ah kuwaas oo maray ugu yaraan hal xariiq oo hore oo daawaynta ah ayaa lagu daray daraasaddan. Darzalex Faspro 1,800 mg/30,000 unug (1,800 mg daratumumab iyo 30,000 units hyaluronidase) ayaa la siiyay subcutaneously oo ay weheliso Kyprolis (20/70 mg/m2 hal mar todobaadkii) iyo dexamethasone bukaanada.
Heerka jawaabta guud wuxuu ahaa cabbirka natiijada waxtarka aasaasiga ah (ORR). ORR ee daraasaddan waxay ahayd 84.8 boqolkiiba (95 boqolkiiba CI: 73.9 boqolkiiba, 92.5 boqolkiiba). Dhererka dhexdhexaadka ah ee jawaabta laguma helin dabagal dhexdhexaad ah oo bilaha 9.2, laakiin lagu qiyaasay 85.2 boqolkiiba (95 boqolkiiba CI: 72.5, 92.3) jawaabta la ilaaliyo ugu yaraan 6 bilood iyo 82.5 boqolkiiba (95 boqolkiiba CI: 68.9, 90.6) jawaabta la joogteeyey ugu yaraan 9 bilood.
Caabuqyada neef-mareenka sare, daal, hurdo la'aan, hypertension, shuban, qufac, dyspnea, madax-xanuun, pyrexia, lallabbo, iyo edoema peripheral ayaa ahaa dhacdooyinka ugu badan ee dhinaca (20%) ee bukaanada lagu daweeyay Darzalex Faspro, Kyprolis, iyo dexamethasone.
Darzalex Faspro waxaa lagu maamulaa subcutaneously qiyaasta 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) hal mar usbuuc kasta laga bilaabo todobaadyada 1 ilaa 8, hal mar 2 asbuuc laga bilaabo todobaadyada 9 ilaa 24, iyo hal mar 4 usbuuc kasta. cudurka horumarka ama sunta aan loo dulqaadan karin.
Hababka lagu taliyey ee qiyaasta Kyprolis marka lagu daro Darzalex Faspro waa kuwan soo socda:
- Hal mar todobaadkii 20/70 mg / m2 nidaamka: Kyprolis 20 mg / m2 oo lagu maamulo faleebo IV ka badan 30 daqiiqo wareegga 1 maalin 1 iyo haddii qiyaasta 20 mg / m2 loo dulqaado, 70 mg / m2 sida faleebo 30-daqiiqo IV ah ee wareegga 1, maalinta 8 iyo maalinta 15, ka dibna maalinta 1, 8, iyo 15 ee wareeg kasta oo 28-maalmood ah.
- Laba jeer toddobaadkii 20/56 mg / m2 nidaamka: Kyprolis 20 mg / m2 oo lagu maamulo faleebo IV ka badan 30 daqiiqo wareegga 1 Maalinta 1 iyo Maalinta 2 iyo, haddii qiyaasta 20 mg / m2 loo dulqaato, 56 mg / m2 waxaa maamula IV faleebo ka badan 30 daqiiqo wareegga 1, maalinta 8, 9, 15, iyo 16, ka dibna maalinta 1, 2, 8, 9, 15, 16 ee wareeg kasta oo 28-maalmood ah.
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