A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Venetoclax; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital /ID# 202431
    • Wahroonga, New South Wales, Australia, 2076
      • Sydney Adventist Hospital /ID# 222874
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital /ID# 205545
  • Queensland
    • Hyde Park, Queensland, Australia, 4812
      • ICON Cancer Care - Townsville /ID# 206565
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre /ID# 205663
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 202432
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Perth Blood Institute Ltd /ID# 206649
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L3
      • BC Cancer - Vancouver /ID# 222804
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 218883
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
      • CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
• China
  • Beijing, China, 100043
    • Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital /ID# 216371
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center /ID# 223828
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 215860
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 215987
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 223143
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 216094
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 216954
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University /ID# 215996
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital of China Medical University /ID# 223435
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital /ID# 218865
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 216647
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital /ID# 223550
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University /ID# 218953
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc /ID# 221290
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze /ID# 221166
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní Nemocnice Brno - Jihlavská /ID# 204512
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové - Sokolská /ID# 221291
  • Ostrava-mesto
    • Ostrava, Ostrava-mesto, Czechia, 708 52
      • Fakultni Nemocnice Ostrava /ID# 204515
• Denmark
  • Roskilde, Denmark, 4000
    • Duplicate_Roskilde Hospital /ID# 223366
  • Hovedstaden
    • Herlev, Hovedstaden, Denmark, 2730
      • Duplicate_Herlev Hospital /ID# 223221
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Aalborg University Hospital /ID# 223220
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense University Hospital /ID# 223217
    • Vejle, Syddanmark, Denmark, 7100
      • Sygehus Lillebalt, Vejle /ID# 223216
• France
  • Ile-de-France
    • Paris Cedex 13, Ile-de-France, France, 75013
      • Hopital Pitie Salpetriere /ID# 214173
  • Isere
    • La Tronche, Isere, France, 38700
      • Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182
  • Marne
    • Reims CEDEX, Marne, France, 51092
      • CHU Reims - Hôpital Robert Debre /ID# 233907
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 201076
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 202213
  • Paris
    • Creteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 202211
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 200099
  • Rhone
    • Pierre Benite CEDEX, Rhone, France, 69495
      • HCL - Hopital Lyon Sud /ID# 200097
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76038
      • Centre Henri Becquerel /ID# 223186
  • Vaucluse
    • Avignon CEDEX 9, Vaucluse, France, 84902
      • CH Henri Duffaut /ID# 234154
• Germany
  • Berlin, Germany, 12203
    • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 215495
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona /ID# 222506
  • Baden-Wuerttemberg
    • Stuttgart, Baden-Wuerttemberg, Germany, 70736
      • Robert-Bosch-Krankenhaus /ID# 223947
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 238646
  • Bayern
    • Wuerzburg, Bayern, Germany, 97080
      • Universitaetsklinikum Wuerzburg /ID# 200055
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Klinikum Chemnitz gGmbH /ID# 233797
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • Universitaetsklinikum Jena /ID# 201254
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
  • Patras, Greece, 26504
    • University Gen Hosp of Patra /ID# 201691
  • Thessaloniki, Greece, 54639
    • Theageneio Anticancer Hospital /ID# 213983
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki George Papanikolaou /ID# 201692
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Alexandra General Hospital /ID# 202386
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 222879
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 244611
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 169678
    • Haifa, H_efa, Israel, 3339419
      • Bnai Zion Medical Center /ID# 169466
    • Haifa, H_efa, Israel, 34362
      • The Lady Davis Carmel Medical Center /ID# 222969
  • HaDarom
    • Ashdod, HaDarom, Israel, 7747629
      • Duplicate_Assuta Ashdod Medical Center /ID# 222968
    • Be'er Sheva, HaDarom, Israel, 8443901
      • Soroka University Medical Center /ID# 218768
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 169778
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 169437
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah /ID# 169474
• Italy
  • Ancona, Italy, 60020
    • Azienda Ospedaliero Universitaria delle Marche /ID# 170950
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 212498
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 222988
  • Terni, Italy, 05100
    • Azienda Ospedaliera Santa Maria Terni /ID# 170948
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 170952
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 170962
  • Potenza
    • Rionero In Vulture, Potenza, Italy, 85028
      • Irccs-Crob /Id# 170955
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 170880
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8567
      • The Jikei University Kashiwa Hospital /ID# 223031
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 171117
  • Gifu
    • Ogaki-shi, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital /ID# 171043
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-8511
      • Gunma University Hospital /ID# 170966
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 170992
  • Ibaraki
    • Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
      • Duplicate_National Hospital Organization Mito Medical Center /ID# 171187
    • Hitachi-shi, Ibaraki, Japan, 317-0077
      • Hitachi General Hospital /ID# 200843
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital /ID# 222849
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 201935
  • Okayama
    • Okayama-shi, Okayama, Japan, 701-1192
      • Okayama Medical Center /ID# 200119
  • Osaka
    • Osaka-shi, Osaka, Japan, 543-8555
      • Japanese Red Cross Osaka Hospital /ID# 171493
    • Suita-shi, Osaka, Japan, 565-0871
      • The University of Osaka Hospital /ID# 201966
  • Tokushima
    • Tokushima-shi, Tokushima, Japan, 770-8503
      • Tokushima University Hospital /ID# 202571
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital /ID# 239014
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Japanese Red Cross Medical Center /ID# 171256
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 238329
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health System Severance Hospital /ID# 202709
  • Gyeonggido
    • Incheon, Gyeonggido, Korea, Republic of, 21565
      • Duplicate_Gachon University Gil Medical Center /ID# 202827
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 234045
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital /ID# 202711
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 202710
  • Ulsan Gwang Yeogsi
    • Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of, 44033
      • Ulsan University Hospital /ID# 222716
• Russian Federation
  • Moscow, Russian Federation, 123182
    • City Clinical Hospital #52 /ID# 206289
  • Saint Petersburg, Russian Federation, 194291
    • Leningrad Regional Clinical Hospital /ID# 202776
  • Sankt-Peterburg, Russian Federation, 197341
    • Almazov National Medical Research Centre /ID# 169681
  • Tula, Russian Federation, 300053
    • Tula Regional Clinical Hospital /ID# 223226
  • Moskva
    • Moscow, Moskva, Russian Federation, 125284
      • Moscow State budget healthcare /ID# 169685
  • Novosibirskaya Oblast
    • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
      • Research Institute of Fundamental and Clinical Immunology /ID# 223594
  • Stavropol Skiy Kray
    • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
      • LLC Novaya Klinika /ID# 169689
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital /ID# 203988
  • Singapore, Singapore, 169608
    • Singapore General Hospital /ID# 202131
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital /ID# 204374
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 218106
  • Girona, Spain, 17007
    • Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
  • Leon, Spain, 24071
    • Hospital de Leon /ID# 233878
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 218107
  • Madrid, Spain, 28041
    • Disc_Hospital Universitario 12 de Octubre /ID# 171288
  • Salamanca, Spain, 37711
    • Hospital Universitario de Salamanca /ID# 171294
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 171286
  • Toledo, Spain, 45007
    • Hospital General Universitario de Toledo /ID# 222887
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 234019
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07120
      • Hospital Universitari Son Espases /ID# 222889
  • Malaga
    • Marbella, Malaga, Spain, 29603
      • Hospital Costa del Sol /ID# 234083
  • Ourense
    • Orense, Ourense, Spain, 32005
      • Complejo Hospitalario Universitario Ourense /ID# 222876
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario Canarias /ID# 238452
• Sweden
  • Norrbottens Lan
    • Lulea, Norrbottens Lan, Sweden, 971 80
      • Sunderby sjukhus /ID# 201314
  • Vastra Gotalands Lan
    • Boras, Vastra Gotalands Lan, Sweden, 501 82
      • Sodra Alvsborgs sjukhus /ID# 213061
    • Linkoping, Vastra Gotalands Lan, Sweden, 581 85
      • Duplicate_Universitetssjukhuset Linköping /ID# 200789
    • Uddevalla, Vastra Gotalands Lan, Sweden, 451 80
      • Uddevalla sjukhus /ID# 201315
• Turkey
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty /ID# 222698
  • Ankara, Turkey, 06590
    • Ankara Univ Medical Faculty /ID# 201881
  • Ankara, Turkey, 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty /ID# 201953
  • Istanbul, Turkey, 34214
    • Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 222697
  • Adana
    • Saricam Adana, Adana, Turkey, 01330
      • Cukurova Universitesi Tip Fakultesi /ID# 201955
  • Izmir
    • Karsiyaka, Izmir, Turkey, 35575
      • Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
• Ukraine
  • Khmelnytskyi, Ukraine, 29000
    • MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942
  • Kyiv, Ukraine, 03022
    • National Cancer Institute /ID# 223944
  • Lviv, Ukraine, 79044
    • SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
  • Cherkaska Oblast
    • Cherkasy, Cherkaska Oblast, Ukraine, 18009
      • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61070
      • Communal non-profit enterprise Regional Center of Oncology /ID# 223945
• United Kingdom
  • London, United Kingdom, SE13 6LH
    • Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
  • Manchester, United Kingdom, M9 2AA
    • Manchester University NHS Foundation Trust /ID# 171440
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals University NHS Trust /ID# 171444
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire NHS Foundation Trust /ID# 217835
  • Sheffield, United Kingdom, S5 7AT
    • Duplicate_Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire /ID# 171447
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital /ID# 223097
  • England
    • London, England, United Kingdom, W12 0HS
      • Hammersmith Hospital /ID# 171446
  • Greater London
    • London, Greater London, United Kingdom, NW1 2BU
      • University College London Hospital /ID# 171428
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Duplicate_Nottingham University Hospitals NHS Trust /ID# 223292
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • Duplicate_NHS Greater Glasgow and Clyde /ID# 202199
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Duplicate_University Hospitals North Midlands - Royal Stoke University Hospital /ID# 218355
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719-1478
      • Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407
  • California
    • Fresno, California, United States, 93703-2223
      • VA Central California Health Care System /ID# 200047
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 171524
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 200075
    • Weston, Florida, United States, 33331-3609
      • Cleveland Clinic Florida /ID# 208884
  • Kentucky
    • Louisville, Kentucky, United States, 40202-3700
      • Duplicate_Norton Cancer Institute /ID# 200834
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore /ID# 217422
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center /ID# 223606
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer In /ID# 201377
    • Detroit, Michigan, United States, 48202
      • Duplicate_Henry Ford Hospital /ID# 171531
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 201091
  • New York
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 200715
  • Ohio
    • Cleveland, Ohio, United States, 44111-5605
      • Fairview Hospital - Moll Pavilion /ID# 208919
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 202247
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Ctr /ID# 200063
  • Texas
    • Houston, Texas, United States, 77030-4000
      • MD Anderson Cancer Center at Texas Medical Center /ID# 200060
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • Huntsman Cancer Institute /ID# 218406
  • Washington
    • Seattle, Washington, United States, 98108-1597
      • VA Puget Sound Health Care System /ID# 222708

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
• Measurable disease at screening as defined per protocol.
• Has received at least 2 prior lines of therapy as described in the protocol.
• Has had documented disease progression on or within 60 days after completion of the last therapy.
• Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
• Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
• Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
• An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
• Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.

Exclusion Criteria:

• History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
• History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
• Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
• Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
• Known central nervous system involvement of MM.
• Concurrent conditions as listed in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 VenDex; Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.	Drug: Dexamethasone; oral, locally available form; Drug: Venetoclax; tablet; oral; Other Names: ABT-199; GDC-0199
Active Comparator: Arm 2 PomDex; Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.	Drug: Dexamethasone; oral, locally available form; Drug: Pomalidomide; capsule, oral; Other Names: Pomalyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.	Up to approximately 43 months from first randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Good Partial Response or Better Response Rate (VGPR)	VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.	Up to approximately 43 months from first randomization
Overall survival (OS)	OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.	Up to approximately 51 months from first randomization
Time to Deterioration in Disease Symptoms	Time to deterioration in disease symptoms is measured by the disease symptom domain of the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20).	Up to approximately 51 months from first randomization
Time to Deterioration in Physical Functioning	Time to deterioration in physical functioning is measured by the physical functioning domain of European Organization for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).	Up to approximately 51 months from first randomization
Change from Baseline in PROMIS Fatigue Score	Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.	Up to approximately 51 months from first randomization
Change from Baseline in BPI-SF Worst Pain Score	Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.	Up to approximately 51 months from first randomization
Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)	EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine."	Up to approximately 51 months from first randomization
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).	Up to approximately 51 months from first randomization
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)	EORTC QLQ-MY20 includes scales for disease symptoms, side effects of treatment, future perspective, and body image. Values for each scale range from 0 to 100.	Up to approximately 51 months from first randomization
Duration of response (DOR)	DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.	Up to approximately 43 months from first randomization
Time to Disease Progression (TTP)	TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.	Up to approximately 43 months from first randomization
Time to Response (TTR)	TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).	Up to approximately 43 months from first randomization
Cmax of Venetoclax	Maximum plasma concentration (Cmax) of venetoclax	Up to approximately 225 days from initial dose
Trough Concentration (Ctrough) of Venetoclax	Observed plasma concentration at trough (Ctrough) of venetoclax.	Up to approximately 225 days from initial dose
Number of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Up to approximately 51 months from first randomization
Overall Response Rate (ORR)	ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.	Up to approximately 43 months from first randomization
Minimal Residual Disease (MRD) Negativity Rate	MRD defined as the percentage of participants with MRD negativity status. MRD negativity will be defined at 10^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).	Up to approximately 43 months from first randomization

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Roche-Genentech
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cancer, Multiple Myeloma (MM), Relapsed or Refractory Multiple Myeloma (R/R MM), pharmacokinetics; CANOVA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Venetoclax; Pomalidomide
• Other Study ID Numbers: M13-494; 2023-506112-40 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No