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ACTIVE NOT RECRUITING
NCT03539744
PHASE3

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.

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2018-10-22

Completion Date

2027-11

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

DRUG

Pomalidomide

capsule, oral

DRUG

Dexamethasone

oral, locally available form

DRUG

Venetoclax

tablet; oral

Locations (180)

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