A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
Inclusion Criteria:
Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group [IMWG] diagnostic criteria)
Transplant ineligibility
Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):
No prior treatment for multiple myeloma
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
Fresno, California 93720, United States
Buenos Aires, Argentina
New South Wales, Australia
Plovdiv, 4002, Bulgaria
Plovdiv, 4002, Bulgaria
Sofia, 1606, Bulgaria
Sofia, 1756, Bulgaria
Hangzhou, Zhejiang, China
Tianjin, China
Brno, 625 00, Czechia
Olomouc, 775 20, Czechia
Prague, 128 08, Czechia
Nîmes, France
Ulm, Baden-Wurttemberg, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg / Saar, Saarland, Germany
Budapest, 1097, Hungary
Budapest, 1122, Hungary
Debrecen, 4032, Hungary
Gyula, 5700, Hungary
Kaposvár, 7400, Hungary
Piacenza, Italy
Koto, Tokyo, Japan
Olsztyn, OIsztyn, Poland
Chorzów, Silesian Voivodeship 41-500, Poland
Katowice, 40-032, Poland
Cluj-Napoca, Cluj 400124, Romania
Târgu Mureş, 540042, Romania
Petrozavodsk, Republic of Karelia 185019, Russia
Izhevsk, 426039, Russia
Moscow, 115478, Russia
Moscow, 125284, Russia
Saint Petersburg, 191024, Russia
Saint Petersburg, 197110, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Hwasun-gun, Jeollanam-do 519-763, South Korea
Tapei, Taiwan
Ankara, Cebeci 06590, Turkey (Türkiye)
Dnipropetrovsk, 49102, Ukraine
Vinnitsya, 21018, Ukraine