A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.
The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival.
The study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.
Inclusion Criteria:
Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.
Female participants who:
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.
Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.
Must meet the following clinical laboratory criteria at study entry:
Exclusion Criteria:
Buenos Aires, Ciudad Autonoma de BuenosAires C1431FWO, Argentina
Salvador, Estado de Bahia 41253-196, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
São José do Rio Preto, 15090-000, Brazil
São Paulo, 05403-000, Brazil
Shanghai, Shanghai Municipality 200025, China
Hangzhou, Zhejiang 310003, China
Bogota, Cundinamarca, Colombia
Copenhagen, Capital 2100, Denmark
Villingen-Schwenningen, Baden-Wurttemberg 78050, Germany
Augsburg, Bavaria 86150, Germany
Herrsching am Ammersee, Bavaria 82211, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Würzburg, 97080, Germany
Athens, Attica 115 28, Greece
Budapest, 1097, Hungary
Beer Yaakov, 70300, Israel
Bologna, Emilia-Romagna 40138, Italy
Brescia, Lombardy 25123, Italy
Milan, Lombardy 20162, Italy
Ancona, 60126, Italy
Bunkyo, Tokyo 113-8431, Japan
Shibuya-ku, Tokyo 150-8935, Japan
Nagaizumi-chō, 4118777, Japan
Narita-shi, 286-8523, Japan
Guadalajara, Jalisco 44160, Mexico
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Lisbon, Lisbon District 1099-023, Portugal
Kirov, 610027, Russia
Saint Petersburg, 197110, Russia
Belgrade, 11000, Serbia
Pozuelo de Alarcón, Madrid, Communidad Delaware 28223, Spain
Stockholm, Södermanland County, Sweden
Stockholm, Södermanland County, Sweden