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.
NCT ID: NCT03539744
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
265 participants
INTERVENTIONAL
2018-10-22
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 VenDex
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Dexamethasone
oral, locally available form
Venetoclax
tablet; oral
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.
Pomalidomide
capsule, oral
Dexamethasone
oral, locally available form
Interventions
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Pomalidomide
capsule, oral
Dexamethasone
oral, locally available form
Venetoclax
tablet; oral
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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.
18 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407
Tucson, Arizona, United States
VA Central California Health Care System /ID# 200047
Fresno, California, United States
University of California, Los Angeles /ID# 171524
Los Angeles, California, United States
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
Aurora, Colorado, United States
Mayo Clinic /ID# 200075
Jacksonville, Florida, United States
Cleveland Clinic Florida /ID# 208884
Weston, Florida, United States
Duplicate_Norton Cancer Institute /ID# 200834
Louisville, Kentucky, United States
University of Maryland, Baltimore /ID# 217422
Baltimore, Maryland, United States
Boston Medical Center /ID# 223606
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer In /ID# 201377
Detroit, Michigan, United States
Duplicate_Henry Ford Hospital /ID# 171531
Detroit, Michigan, United States
Mayo Clinic - Rochester /ID# 201091
Rochester, Minnesota, United States
Columbia University Medical Center /ID# 200715
New York, New York, United States
Fairview Hospital - Moll Pavilion /ID# 208919
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 202247
Cleveland, Ohio, United States
UPMC Hillman Cancer Ctr /ID# 200063
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 200060
Houston, Texas, United States
Huntsman Cancer Institute /ID# 218406
Salt Lake City, Utah, United States
VA Puget Sound Health Care System /ID# 222708
Seattle, Washington, United States
Liverpool Hospital /ID# 202431
Liverpool, New South Wales, Australia
Sydney Adventist Hospital /ID# 222874
Wahroonga, New South Wales, Australia
Wollongong Hospital /ID# 205545
Wollongong, New South Wales, Australia
ICON Cancer Care - Townsville /ID# 206565
Hyde Park, Queensland, Australia
Icon Cancer Centre /ID# 205663
South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital /ID# 202432
Woodville South, South Australia, Australia
Perth Blood Institute Ltd /ID# 206649
Nedlands, Western Australia, Australia
Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846
Calgary, Alberta, Canada
BC Cancer - Vancouver /ID# 222804
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 218883
Halifax, Nova Scotia, Canada
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
Lévis, Quebec, Canada
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 216371
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center /ID# 223828
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital /ID# 215860
Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 215987
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850
Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 223143
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 216094
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 216954
Nanchang, Jiangxi, China
The First Hospital of China Medical University /ID# 215996
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University /ID# 223435
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital /ID# 218865
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 216647
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital /ID# 223550
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 218953
Wenzhou, Zhejiang, China
Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033
Beijing, , China
Fakultní Nemocnice Brno - Jihlavská /ID# 204512
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 221291
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 204515
Ostrava, Ostrava-mesto, Czechia
Fakultni nemocnice Olomouc /ID# 221290
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 221166
Prague, , Czechia
Duplicate_Herlev Hospital /ID# 223221
Herlev, Capital Region, Denmark
Aalborg University Hospital /ID# 223220
Aalborg, North Denmark, Denmark
Odense University Hospital /ID# 223217
Odense, Region Syddanmark, Denmark
Sygehus Lillebalt, Vejle /ID# 223216
Vejle, Region Syddanmark, Denmark
Duplicate_Roskilde Hospital /ID# 223366
Roskilde, , Denmark
Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182
La Tronche, Isere, France
CHU Reims - Hôpital Robert Debre /ID# 233907
Reims, Marne, France
CHRU Nancy - Hopitaux de Brabois /ID# 201076
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille - Hopital Claude Huriez /ID# 202213
Lille, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 202211
Créteil, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 200099
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 200097
Pierre-Bénite, Rhone, France
Centre Henri Becquerel /ID# 223186
Rouen, Seine-Maritime, France
CH Henri Duffaut /ID# 234154
Avignon, Vaucluse, France
Hopital Pitie Salpetriere /ID# 214173
Paris, Île-de-France Region, France
Robert-Bosch-Krankenhaus /ID# 223947
Stuttgart, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 238646
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 200055
Würzburg, Bavaria, Germany
Klinikum Chemnitz gGmbH /ID# 233797
Chemnitz, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Jena /ID# 201254
Jena, Thuringia, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 215495
Hamburg, , Germany
Asklepios Klinik Altona /ID# 222506
Hamburg, , Germany
Alexandra General Hospital /ID# 202386
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 222879
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
Athens, , Greece
University Gen Hosp of Patra /ID# 201691
Pátrai, , Greece
Theageneio Anticancer Hospital /ID# 213983
Thessaloniki, , Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 201692
Thessaloniki, , Greece
Rambam Health Care Campus /ID# 169678
Haifa, H_efa, Israel
Bnai Zion Medical Center /ID# 169466
Haifa, H_efa, Israel
The Lady Davis Carmel Medical Center /ID# 222969
Haifa, H_efa, Israel
Hadassah /ID# 169474
Jerusalem, Jerusalem, Israel
Duplicate_Assuta Ashdod Medical Center /ID# 222968
Ashdod, Southern District, Israel
Soroka University Medical Center /ID# 218768
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 169778
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 169437
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 244611
Petah Tikva, , Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 170952
Bologna, Emilia-Romagna, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 170962
Turin, Piedmont, Italy
Irccs-Crob /Id# 170955
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 170950
Ancona, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 212498
Milan, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 222988
Palermo, , Italy
Azienda Ospedaliera Santa Maria Terni /ID# 170948
Terni, , Italy
Nagoya City University Hospital /ID# 170880
Nagoya, Aichi-ken, Japan
The Jikei University Kashiwa Hospital /ID# 223031
Kashiwa-shi, Chiba, Japan
Kyushu University Hospital /ID# 171117
Fukuoka, Fukuoka, Japan
Ogaki Municipal Hospital /ID# 171043
Ogaki-shi, Gifu, Japan
Gunma University Hospital /ID# 170966
Maebashi, Gunma, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
Hiroshima, Hiroshima, Japan
Kobe City Medical Center General Hospital /ID# 170992
Kobe, Hyōgo, Japan
Duplicate_National Hospital Organization Mito Medical Center /ID# 171187
Higashi Ibaraki-gun, Ibaraki, Japan
Hitachi General Hospital /ID# 200843
Hitachi-shi, Ibaraki, Japan
Iwate Medical University Hospital /ID# 222849
Shiwa-gun, Iwate, Japan
Tohoku University Hospital /ID# 201935
Sendai, Miyagi, Japan
Okayama Medical Center /ID# 200119
Okayama, Okayama-ken, Japan
Japanese Red Cross Osaka Hospital /ID# 171493
Osaka, Osaka, Japan
The University of Osaka Hospital /ID# 201966
Suita-shi, Osaka, Japan
Tokushima University Hospital /ID# 202571
Tokushima, Tokushima, Japan
The Jikei University Hospital /ID# 239014
Minato-ku, Tokyo, Japan
Japanese Red Cross Medical Center /ID# 171256
Shibuya-ku, Tokyo, Japan
Yamagata University Hospital /ID# 238329
Yamagata, Yamagata, Japan
Moscow State budget healthcare /ID# 169685
Moscow, Moscow, Russia
Research Institute of Fundamental and Clinical Immunology /ID# 223594
Novosibirsk, Novosibirsk Oblast, Russia
LLC Novaya Klinika /ID# 169689
Pyatigorsk, Stavropol Kray, Russia
City Clinical Hospital #52 /ID# 206289
Moscow, , Russia
Leningrad Regional Clinical Hospital /ID# 202776
Saint Petersburg, , Russia
Almazov National Medical Research Centre /ID# 169681
Saint Petersburg, , Russia
Tula Regional Clinical Hospital /ID# 223226
Tula, , Russia
National University Hospital /ID# 203988
Singapore, , Singapore
Singapore General Hospital /ID# 202131
Singapore, , Singapore
Tan Tock Seng Hospital /ID# 204374
Singapore, , Singapore
Duplicate_Gachon University Gil Medical Center /ID# 202827
Incheon, Gyeonggido, South Korea
Seoul National University Hospital /ID# 202711
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 202710
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 234045
Seoul, Seoul Teugbyeolsi, South Korea
Ulsan University Hospital /ID# 222716
Ulsan, Ulsan Gwang Yeogsi, South Korea
Yonsei University Health System Severance Hospital /ID# 202709
Seoul, , South Korea
Hospital Universitari Son Espases /ID# 222889
Palma de Mallorca, Balearic Islands, Spain
Hospital Costa del Sol /ID# 234083
Marbella, Malaga, Spain
Complejo Hospitalario Universitario Ourense /ID# 222876
Ourense, Ourense, Spain
Hospital Universitario Canarias /ID# 238452
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario Vall d'Hebron /ID# 218106
Barcelona, , Spain
Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
Girona, , Spain
Hospital de Leon /ID# 233878
León, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
Madrid, , Spain
Disc_Hospital Universitario 12 de Octubre /ID# 171288
Madrid, , Spain
Hospital Universitario La Paz /ID# 218107
Madrid, , Spain
Hospital Universitario de Salamanca /ID# 171294
Salamanca, , Spain
Hospital Universitario Virgen del Rocio /ID# 171286
Seville, , Spain
Hospital General Universitario de Toledo /ID# 222887
Toledo, , Spain
Hospital Universitario y Politecnico La Fe /ID# 234019
Valencia, , Spain
Sunderby sjukhus /ID# 201314
Luleå, Norrbotten County, Sweden
Sodra Alvsborgs sjukhus /ID# 213061
Borås, Västra Götaland County, Sweden
Duplicate_Universitetssjukhuset Linköping /ID# 200789
Linkoping, Västra Götaland County, Sweden
Uddevalla sjukhus /ID# 201315
Uddevalla, Västra Götaland County, Sweden
Cukurova Universitesi Tip Fakultesi /ID# 201955
Saricam Adana, Adana, Turkey (Türkiye)
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
Cordaleo, İzmir, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty /ID# 222698
Ankara, , Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 201881
Ankara, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty /ID# 201953
Istanbul, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty /ID# 222697
Izmir, , Turkey (Türkiye)
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
Cherkasy, Cherkasy Oblast, Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 223945
Kharkiv, Kharkivs’ka Oblast’, Ukraine
MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942
Khmelnytskyi, , Ukraine
National Cancer Institute /ID# 223944
Kyiv, , Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
Lviv, , Ukraine
Addenbrooke's Hospital /ID# 223097
Cambridge, Cambridgeshire, United Kingdom
Hammersmith Hospital /ID# 171446
London, England, United Kingdom
University College London Hospital /ID# 171428
London, Greater London, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
Norwich, Norfolk, United Kingdom
Duplicate_Nottingham University Hospitals NHS Trust /ID# 223292
Nottingham, Nottinghamshire, United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 202199
Glasgow, Scotland, United Kingdom
Duplicate_University Hospitals North Midlands - Royal Stoke University Hospital /ID# 218355
Stoke-on-Trent, Staffordshire, United Kingdom
Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
London, , United Kingdom
Manchester University NHS Foundation Trust /ID# 171440
Manchester, , United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 171444
Portsmouth, , United Kingdom
Royal Berkshire NHS Foundation Trust /ID# 217835
Reading, , United Kingdom
Duplicate_Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire /ID# 171447
Sheffield, , United Kingdom
Countries
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Related Links
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Related info
Other Identifiers
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2023-506112-40
Identifier Type: OTHER
Identifier Source: secondary_id
M13-494
Identifier Type: -
Identifier Source: org_study_id
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