March 2022: Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) uye carfilzomib (Kyprolis, Amgen, Inc.) pamwe nedexamethasone zvakatenderwa neChikafu neDrug Administration kune varwere vakuru vane kudzokazve kana kuti refractory multiple myeloma vakagamuchira 1 kusvika 3 mitsara yekutanga yekurapa.
PLEIADES (NCT03412565), yakawanda-cohort, yakazaruka-label muedzo, yakashandiswa kuongorora kushanda mune imwe-ruoko ruoko cohort. 66 vanhu vane kudzokazve kana kuti refractory multiple myeloma avo vakanga vambotora imwe yekutanga mutsara wekurapa vakabatanidzwa muchidzidzo ichi. Darzalex Faspro 1,800 mg/30,000 units (1,800 mg daratumumab uye 30,000 units hyaluronidase) yakapiwa pasi pecutaneously pamwe neKyprolis (20/70 mg/m2 kamwe chete pavhiki chirongwa) uye dexamethasone kuvarwere.
Huwandu hwekupindura hwese hwaive hwekutanga hwekuita mhedzisiro chiyero (ORR). Iyo ORR yechidzidzo ichi yaive 84.8 muzana (95 muzana CI: 73.9 muzana, 92.5 muzana). Hurefu hwepakati hwekupindura hwakanga husati hwawanikwa pakutevera kwepakati kwemwedzi ye9.2, asi inofungidzirwa kuti 85.2 muzana (95 muzana CI: 72.5, 92.3) yakachengetedza mhinduro kweinenge mwedzi mitanhatu uye 6 muzana (82.5 muzana CI: 95, 68.9) yakachengetedza mhinduro kweinenge mwedzi 90.6.
Zvirwere zvepamusoro zvekufema, kuneta, kushaya hope, hypertension, manyoka, kukosora, dyspnea, kutemwa nemusoro, pyrexia, kusvotwa, uye edoema peripheral ndizvo zvaive zvakanyanya kuitika padivi (20%) muvarwere vanobatwa neDarzalex Faspro, Kyprolis, uye dexamethasone.
Darzalex Faspro inoshandiswa pasi pasi pachiyero che 1,800 mg / 30,000 units (1,800 mg daratumumab uye 30,000 units hyaluronidase) kamwe chete vhiki nevhiki kubva Vhiki 1 kusvika ku8, kamwe chete mavhiki e2 kubva Mavhiki 9 kusvika ku24 vhiki imwe neimwe kusvika kamwe chete vhiki dze4. kukura kwechirwere kana huturu husingagoneki.
Iwo anokurudzirwa dosage regimens eKyprolis kana akabatwa pamwe chete neDarzalex Faspro ndeaya anotevera:
- Kamwe vhiki nevhiki 20/70 mg/m2 regimen: Kyprolis 20 mg/m2 inotungamirirwa neIV infusion pamusoro pemaminitsi makumi matatu paCycle 30 Zuva 1 uye kana chiyero che 1 mg / m20 chichibvumirwa, 2 mg / m70 se 2-minute IV infusion. paCycle 30, Day 1 uye Day 8, uyezve Zuva 15, 1, uye 8 ega ega yemazuva makumi maviri nemasere.
- Kaviri pavhiki 20/56 mg/m2 regimen: Kyprolis 20 mg/m2 inotungamirirwa neIV infusion pamusoro pemaminitsi makumi matatu paCycle 30 Zuva 1 uye Zuva 1 uye, kana chiyero che 2 mg / m20 chichibvumirwa, 2 mg / m56 inotungamirirwa neIV. infusion pamusoro pemaminitsi makumi matatu paCycle 2, Zuva 30, 1, 8, uye 9, uyezve paZuva 15, 16, 1, 2, 8, 9 yemazuva makumi maviri nemasere ekutenderera.
CAR T-Cell therapy ndeimwe yeazvino kurapa kwekubudirira mukurapa kwakawanda myeloma. Ziva zvimwe nezveCAR T-Cell therapy pano.
