291
Participants
Start Date
July 11, 2016
Primary Completion Date
March 15, 2021
Study Completion Date
August 15, 2022
Venetoclax
Participants self-administered venetoclax tablets by mouth QD in combination with bortezomib. Venetoclax was to be given before other agents administered on the same day, if applicable. Each venetoclax dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.
Bortezomib
Bortezomib (subcutaneous injection \[preferred\] or IV) was given following administration of venetoclax or placebo in Cycles 1 -8 on Days 1, 4, 8 and 11, and for Cycles 9 and beyond, on Days 1, 8, 15 and 22 and was to be administered per the prescribing information. The route of administration was to stay the same during the study.
Dexamethasone
Dexamethasone was to be given orally, administered per the prescribing information, the day of bortezomib dosing and the following day, given the protocol-defined dosing window (bortezomib dosing window is ± 1 day) is maintained. If bortezomib was interrupted or a dose is skipped, dexamethasone was to be administered as scheduled per protocol (unless dexamethasone was interrupted due to toxicity).
Placebo for venetoclax
Participants self-administered placebo tablets by mouth QD in combination with bortezomib. Placebo was to be given before other agents administered on the same day, if applicable. Each placebo dose was to be taken all at one time with approximately 240 mL of water within 30 minutes after completion of breakfast or the subject's first meal of the day. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed. On days that pre-dose PK sampling was required, dosing occurred at the clinic to facilitate PK sampling.
National Taiwan University Hospital /ID# 154444, Taipei
Semmelweis Egyetem /ID# 152519, Budapest
Semmelweis Egyetem /ID# 152520, Budapest
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518, Budapest
Royal Prince Alfred Hospital /ID# 149108, Camperdown
Concord Repatriation General Hospital /ID# 149106, Concord
Liverpool Hospital /ID# 149110, Liverpool
Peter MacCallum Cancer Ctr /ID# 149107, Melbourne
Alfred Health /ID# 150085, Melbourne
Box Hill Hospital /ID# 149112, Box Hill
Royal Brisbane and Women's Hospital /ID# 149105, Herston
Debreceni Egyetem Klinikai Kozpont /ID# 152517, Debrecen
The Queen Elizabeth Hospital /ID# 149104, Woodville South
Perth Blood Institute Ltd /ID# 148966, Nedlands
Fiona Stanley Hospital /ID# 148967, Murdoch
Royal Hobart Hospital /ID# 149111, Hobart
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516, Kaposvár
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949, Berlin
A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943, Turin
National Cancer Center /ID# 150889, Goyang
Taipei Veterans General Hosp /ID# 154445, Taipei
Seoul National University Bundang Hospital /ID# 150888, Seongnam
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414, Cherkasy
Gachon University Gil Medical Center /ID# 150893, Incheon
Asklepios Klinik Altona /ID# 150116, Hamburg
Hospital Universitario de la Princesa /ID# 148980, Madrid
Hospital Universitario 12 de Octubre /ID# 148981, Madrid
CHRU de Brest - Hopital Morvan /ID# 149299, Brest
CHU Grenoble - Hopital Michallon /ID# 149301, La Tronche
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936, Bologna
China Medical University Hospital /ID# 154446, Taichung
CHU de Nantes, Hotel Dieu -HME /ID# 149294, Nantes
Gabrail Cancer Center Research /ID# 149098, Canton
Hospital Universitario Dr. Peset /ID# 148986, Valencia
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411, Dnipro
Changhua Christian Hospital /ID# 154447, Changhua City, Changhua County
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942, Ancona
Chonnam National University Hospital /ID# 150894, Gwangju
Duplicate_Centre Hospitalier Lyon Sud /ID# 149300, Pierre-Bénite
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524, Aurora
Univ of Colorado Cancer Center /ID# 149130, Aurora
CHU Limoges - Dupuytren 1 /ID# 149292, Limoges
Central Clinical Hospital RZHD Medicine /ID# 148954, Moscow
LLC Novaya Klinika /ID# 148974, Pyatigorsk
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956, Ryazan
Samara State Medical University /ID# 148952, Samara
Bashkir State Medical University /ID# 151206, Ufa
Clinical Oncology Dispensary of Omsk /ID# 148953, Omsk
Kuzbass Regional Clinical Hospital /ID# 148955, Kemerovo
Tohoku University Hospital /ID# 150945, Sendai
Duke Cancer Center /ID# 149099, Durham
Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290, Goiânia
Liga Norte Riograndense Contra o Câncer /ID# 149023, Natal
Hospital Sao Lucas da PUCRS /ID# 149027, Porto Alegre
Clinica Sao Germano /ID# 149851, São Paulo
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020, Rio de Janeiro
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025, São Paulo
Victoria Hospital /ID# 149846, London
CISSS de la Monteregie /ID# 149844, Greenfield Park
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948, Dresden
University Hospital Galway /ID# 149061, Galway
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939, Rome
Ospedale S.Eugenio /ID# 148938, Rome
Nagoya City University Hospital /ID# 150943, Nagoya
Kyushu University Hospital /ID# 150896, Fukuoka
Ogaki Municipal Hospital /ID# 150783, Ogaki-shi
Gunma University Hospital /ID# 150275, Maebashi
National Hospital Organization Shibukawa Medical Center /ID# 150281, Shibukawa-shi
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242, Hiroshima
Kobe City Medical Center General Hospital /ID# 150944, Kobe
National Hospital Organization Mito Medical Center /ID# 151051, Higashi Ibaraki-gun
Duplicate_Kyoto Prefectural University of Medicine /ID# 150719, Kyoto
JCHO Kyoto Kuramaguchi Medical /ID# 150781, Kyoto
Okayama Medical Center /ID# 150717, Okayama
Japanese Red Cross Osaka Hospital /ID# 150716, Osaka
Saitama Medical Center /ID# 151044, Kawagoe-shi
Tochigi Cancer Center /ID# 150192, Utsunomiya
National Cancer Center Hospital /ID# 151039, Chuo-ku
The Cancer Institute Hospital Of JFCR /ID# 150780, Koto-ku
Japanese Red Cross Medical Center /ID# 149902, Shibuya-ku
National Hospital Organization Disaster Medical Center /ID# 150784, Tachikawa-shi
Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891, Seoul
Seoul National University Hospital /ID# 150890, Seoul
Samsung Medical Center /ID# 150892, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895, Seoul
Hospital Duran i Reynals /ID# 148989, L'Hospitalet de Llobregat
National Cancer Institute /ID# 152413, Kyiv
Leicester Royal Infirmary /ID# 149057, Leicester
Barts Health NHS Trust /ID# 149050, London
Nottingham University Hospitals NHS Trust /ID# 149047, Nottingham
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058, Blackpool
East Kent Hospitals University NHS Foundation Trust /ID# 149059, Canterbury
University College London Hospitals NHS Foundation Trust /ID# 149044, London
King's College Hospital NHS Foundation Trust /ID# 149045, London
Manchester University NHS Foundation Trust /ID# 149046, Manchester
Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055, Romford
The Royal Wolverhampton NHS Trust /ID# 149043, Wolverhampton
Lead Sponsor
Collaborators (1)
Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY