Τίτλος:
Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over the past decade, the disease remains incurable; therefore, additional therapies are needed. Novel combination therapies incorporating monoclonal antibodies have shown significant promise. Here we describe the design of a Phase III study (NCT03275285, IKEMA), which is evaluating isatuximab plus carfilzomib and low-dose dexamethasone, versus carfilzomib/dexamethasone in relapsed/refractory multiple myeloma. The primary end point is progression-free survival. Responses are being determined by an independent review committee using 2016 International Myeloma Working Group criteria, and safety will be assessed throughout. The first patient was recruited in November 2017, and the last patient was recruited in March 2019; 302 patients have been randomized, and the study is ongoing. Clinical trial registration: NCT0327528. © 2019 © 2019 Thomas Martin.
Συγγραφείς:
Moreau, P.
Dimopoulos, M.A.
Yong, K.
Mikhael, J.
Risse, M.-L.
Asset, G.
Martin, T.
Περιοδικό:
Future Oncology
Εκδότης:
Future Medicine Ltd
Λέξεις-κλειδιά:
carfilzomib; dexamethasone; isatuximab; antineoplastic agent; carfilzomib; dexamethasone; isatuximab; monoclonal antibody; oligopeptide, adult; cancer recurrence; cancer survival; controlled study; drug efficacy; drug safety; human; low drug dose; major clinical study; multiple myeloma; open study; parallel design; phase 3 clinical trial; priority journal; progression free survival; prospective study; randomized controlled trial; Review; young adult; adolescent; aged; clinical trial; disease free survival; drug resistance; female; international cooperation; male; middle aged; multicenter study; multiple myeloma; pathology; procedures; salvage therapy; survival rate; tumor recurrence; very elderly, Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Disease-Free Survival; Drug Resistance, Neoplasm; Female; Humans; International Agencies; Male; Middle Aged; Multiple Myeloma; Neoplasm Recurrence, Local; Oligopeptides; Prospective Studies; Salvage Therapy; Survival Rate; Young Adult
DOI:
10.2217/fon-2019-0431
