AzTrials
AzTrials

Multiple MyelomaPhase 3NCT03539744

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 study testing Pomalidomide, Dexamethasone and Venetoclax in people with Multiple Myeloma, run by AbbVie at 180 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Pomalidomide, Dexamethasone and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
180 sitesin 20 countries
Study dates
22 Oct 2018to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

180 sites in 20 countries.

180 sites in 20 countries

China21 sites

  • Beijing Chaoyang Hospital,Capital Medical University /ID# 216014

    Beijing, Beijing Municipality, 100020

  • Peking University Third Hospital /ID# 216371

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040

    Beijing, Beijing Municipality, 100730

  • Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033

    Beijing, 100043

  • West China Hospital, Sichuan University /ID# 216647

    Chengdu, Sichuan, 610041

  • Sun Yat-Sen University Cancer Center /ID# 223828

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital /ID# 215860

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Nanchang University /ID# 216954

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 223143

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Tongji Hospital /ID# 218865

    Shanghai, Shanghai Municipality, 200065

  • The First Hospital of China Medical University /ID# 215996

    Shenyang, Liaoning, 110001

  • Shengjing Hospital of China Medical University /ID# 223435

    Shenyang, Liaoning, 110022

  • The First Affiliated Hospital of Soochow University /ID# 216094

    Suzhou, Jiangsu, 215006

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute & Hospital /ID# 223550

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 218953

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital /ID# 215987

    Zhengzhou, Henan, 450008

Other trials in China

United States19 sites

  • Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904

    Aurora, Colorado, 80045

  • University of Maryland, Baltimore /ID# 217422

    Baltimore, Maryland, 21201

  • Boston Medical Center /ID# 223606

    Boston, Massachusetts, 02118

  • Fairview Hospital - Moll Pavilion /ID# 208919

    Cleveland, Ohio, 44111-5605

  • Cleveland Clinic Main Campus /ID# 202247

    Cleveland, Ohio, 44195

  • Barbara Ann Karmanos Cancer In /ID# 201377

    Detroit, Michigan, 48201

  • Duplicate_Henry Ford Hospital /ID# 171531

    Detroit, Michigan, 48202

  • VA Central California Health Care System /ID# 200047

    Fresno, California, 93703-2223

  • MD Anderson Cancer Center at Texas Medical Center /ID# 200060

    Houston, Texas, 77030-4000

  • Mayo Clinic /ID# 200075

    Jacksonville, Florida, 32224

  • University of California, Los Angeles /ID# 171524

    Los Angeles, California, 90095

  • Duplicate_Norton Cancer Institute /ID# 200834

    Louisville, Kentucky, 40202-3700

  • Columbia University Medical Center /ID# 200715

    New York, New York, 10032-3729

  • UPMC Hillman Cancer Ctr /ID# 200063

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic - Rochester /ID# 201091

    Rochester, Minnesota, 55905-0001

  • Huntsman Cancer Institute /ID# 218406

    Salt Lake City, Utah, 84112-5500

  • VA Puget Sound Health Care System /ID# 222708

    Seattle, Washington, 98108-1597

  • Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407

    Tucson, Arizona, 85719-1478

  • Cleveland Clinic Florida /ID# 208884

    Weston, Florida, 33331-3609

Other trials in United States

Japan18 sites

  • Kyushu University Hospital /ID# 171117

    Fukuoka, Fukuoka, 812-8582

  • Duplicate_National Hospital Organization Mito Medical Center /ID# 171187

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255

    Hiroshima, Hiroshima, 730-8619

  • Hitachi General Hospital /ID# 200843

    Hitachi-shi, Ibaraki, 317-0077

  • The Jikei University Kashiwa Hospital /ID# 223031

    Kashiwa-shi, Chiba, 277-8567

  • Kobe City Medical Center General Hospital /ID# 170992

    Kobe, Hyōgo, 650-0047

  • Gunma University Hospital /ID# 170966

    Maebashi, Gunma, 371-8511

  • The Jikei University Hospital /ID# 239014

    Minato-ku, Tokyo, 105-8471

  • Nagoya City University Hospital /ID# 170880

    Nagoya, Aichi-ken, 467-8602

  • Ogaki Municipal Hospital /ID# 171043

    Ogaki-shi, Gifu, 503-8502

  • Okayama Medical Center /ID# 200119

    Okayama, Okayama-ken, 701-1192

  • Japanese Red Cross Osaka Hospital /ID# 171493

    Osaka, Osaka, 543-8555

  • Tohoku University Hospital /ID# 201935

    Sendai, Miyagi, 9808574

  • Japanese Red Cross Medical Center /ID# 171256

    Shibuya-ku, Tokyo, 150-8935

  • Iwate Medical University Hospital /ID# 222849

    Shiwa-gun, Iwate, 028-3695

  • The University of Osaka Hospital /ID# 201966

    Suita-shi, Osaka, 565-0871

  • Tokushima University Hospital /ID# 202571

    Tokushima, Tokushima, 770-8503

  • Yamagata University Hospital /ID# 238329

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Spain14 sites

  • Hospital Universitario Vall d'Hebron /ID# 218106

    Barcelona, 08035

  • Instituto Catalan de Oncologia (ICO) Girona /ID# 171311

    Girona, 17007

  • Hospital de Leon /ID# 233878

    León, 24071

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 171304

    Madrid, 28040

  • Disc_Hospital Universitario 12 de Octubre /ID# 171288

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 218107

    Madrid, 28046

  • Hospital Costa del Sol /ID# 234083

    Marbella, Malaga, 29603

  • Complejo Hospitalario Universitario Ourense /ID# 222876

    Ourense, Ourense, 32005

  • Hospital Universitari Son Espases /ID# 222889

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario de Salamanca /ID# 171294

    Salamanca, 37711

  • Hospital Universitario Canarias /ID# 238452

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Universitario Virgen del Rocio /ID# 171286

    Seville, 41013

  • Hospital General Universitario de Toledo /ID# 222887

    Toledo, 45007

  • Hospital Universitario y Politecnico La Fe /ID# 234019

    Valencia, 46026

Other trials in Spain

United Kingdom12 sites

  • Addenbrooke's Hospital /ID# 223097

    Cambridge, Cambridgeshire, CB2 2QQ

  • Duplicate_NHS Greater Glasgow and Clyde /ID# 202199

    Glasgow, Scotland, G12 0XH

  • Hammersmith Hospital /ID# 171446

    London, England, W12 0HS

  • University College London Hospital /ID# 171428

    London, Greater London, NW1 2BU

  • Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445

    London, SE13 6LH

  • Manchester University NHS Foundation Trust /ID# 171440

    Manchester, M9 2AA

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213

    Norwich, Norfolk, NR4 7UY

  • Duplicate_Nottingham University Hospitals NHS Trust /ID# 223292

    Nottingham, Nottinghamshire, NG5 1PB

  • Portsmouth Hospitals University NHS Trust /ID# 171444

    Portsmouth, PO6 3LY

  • Royal Berkshire NHS Foundation Trust /ID# 217835

    Reading, RG1 5AN

  • Duplicate_Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire /ID# 171447

    Sheffield, S5 7AT

  • Duplicate_University Hospitals North Midlands - Royal Stoke University Hospital /ID# 218355

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

France10 sites

  • CH Henri Duffaut /ID# 234154

    Avignon, Vaucluse, 84902

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 202211

    Créteil, Paris, 94010

  • Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 202213

    Lille, Nord, 59037

  • CHU de Nantes, Hotel Dieu -HME /ID# 200099

    Nantes, Pays de la Loire Region, 44000

  • Hopital Pitie Salpetriere /ID# 214173

    Paris, Île-de-France Region, 75013

  • HCL - Hopital Lyon Sud /ID# 200097

    Pierre-Bénite, Rhone, 69495

  • CHU Reims - Hôpital Robert Debre /ID# 233907

    Reims, Marne, 51092

  • Centre Henri Becquerel /ID# 223186

    Rouen, Seine-Maritime, 76038

  • CHRU Nancy - Hopitaux de Brabois /ID# 201076

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

Germany9 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051

    Berlin, 12203

  • Klinikum Chemnitz gGmbH /ID# 233797

    Chemnitz, Saxony, 09116

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 215495

    Hamburg, 20246

  • Asklepios Klinik Altona /ID# 222506

    Hamburg, 22763

  • Universitaetsklinikum Jena /ID# 201254

    Jena, Thuringia, 07747

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830

    Kiel, Schleswig-Holstein, 24105

  • Robert-Bosch-Krankenhaus /ID# 223947

    Stuttgart, Baden-Wurttemberg, 70736

  • Universitaetsklinikum Tuebingen /ID# 238646

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg /ID# 200055

    Würzburg, Bavaria, 97080

Other trials in Germany

Israel9 sites

  • Duplicate_Assuta Ashdod Medical Center /ID# 222968

    Ashdod, Southern District, 7747629

  • Soroka University Medical Center /ID# 218768

    Beersheba, Southern District, 8443901

  • Rambam Health Care Campus /ID# 169678

    Haifa, H_efa, 3109601

  • Bnai Zion Medical Center /ID# 169466

    Haifa, H_efa, 3339419

  • The Lady Davis Carmel Medical Center /ID# 222969

    Haifa, H_efa, 34362

  • Hadassah /ID# 169474

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center /ID# 244611

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 169778

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 169437

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)9 sites

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956

    Ankara, 06200

  • Gazi University Medical Faculty /ID# 222698

    Ankara, 06560

  • Ankara Univ Medical Faculty /ID# 201881

    Ankara, 06590

  • Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954

    Cordaleo, İzmir, 35575

  • Istanbul University Istanbul Medical Faculty /ID# 201953

    Istanbul, 34093

  • Bagcilar Medipol Mega Universite Hastanesi /ID# 222914

    Istanbul, 34214

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952

    Istanbul, 34899

  • Ege University Medical Faculty /ID# 222697

    Izmir, 35040

  • Cukurova Universitesi Tip Fakultesi /ID# 201955

    Saricam Adana, Adana, 01330

Other trials in Turkey (Türkiye)

Australia7 sites

  • ICON Cancer Care - Townsville /ID# 206565

    Hyde Park, Queensland, 4812

  • Liverpool Hospital /ID# 202431

    Liverpool, New South Wales, 2170

  • Perth Blood Institute Ltd /ID# 206649

    Nedlands, Western Australia, 6009

  • Icon Cancer Centre /ID# 205663

    South Brisbane, Queensland, 4101

  • Sydney Adventist Hospital /ID# 222874

    Wahroonga, New South Wales, 2076

  • Wollongong Hospital /ID# 205545

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital /ID# 202432

    Woodville South, South Australia, 5011

Other trials in Australia

Italy7 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 170950

    Ancona, 60020

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 170952

    Bologna, Emilia-Romagna, 40138

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 212498

    Milan, 20122

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 222988

    Palermo, 90146

  • Irccs-Crob /Id# 170955

    Rionero in Vulture, Potenza, 85028

  • Azienda Ospedaliera Santa Maria Terni /ID# 170948

    Terni, 05100

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 170962

    Turin, Piedmont, 10126

Other trials in Italy

Russia7 sites

  • Moscow State budget healthcare /ID# 169685

    Moscow, Moscow, 125284

  • City Clinical Hospital #52 /ID# 206289

    Moscow, 123182

  • Research Institute of Fundamental and Clinical Immunology /ID# 223594

    Novosibirsk, Novosibirsk Oblast, 630099

  • LLC Novaya Klinika /ID# 169689

    Pyatigorsk, Stavropol Kray, 357500

  • Leningrad Regional Clinical Hospital /ID# 202776

    Saint Petersburg, 194291

  • Almazov National Medical Research Centre /ID# 169681

    Saint Petersburg, 197341

  • Tula Regional Clinical Hospital /ID# 223226

    Tula, 300053

Other trials in Russia

Greece6 sites

  • Alexandra General Hospital /ID# 202386

    Athens, Attica, 11528

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 222879

    Heraklion, Crete, 71500

  • University Gen Hosp of Patra /ID# 201691

    Pátrai, 26504

  • Theageneio Anticancer Hospital /ID# 213983

    Thessaloniki, 54639

  • General Hospital of Thessaloniki George Papanikolaou /ID# 201692

    Thessaloniki, 57010

Other trials in Greece

South Korea6 sites

  • Duplicate_Gachon University Gil Medical Center /ID# 202827

    Incheon, Gyeonggido, 21565

  • Seoul National University Hospital /ID# 202711

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 202710

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 234045

    Seoul, Seoul Teugbyeolsi, 06591

  • Yonsei University Health System Severance Hospital /ID# 202709

    Seoul, 03722

  • Ulsan University Hospital /ID# 222716

    Ulsan, Ulsan Gwang Yeogsi, 44033

Other trials in South Korea

Czechia5 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 204512

    Brno, Brno-mesto, 625 00

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 221291

    Hradec Králové, Hradec Kralove, 500 05

  • Fakultni nemocnice Olomouc /ID# 221290

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava /ID# 204515

    Ostrava, Ostrava-mesto, 708 52

  • Vseobecna fakultni nemocnice v Praze /ID# 221166

    Prague, 128 08

Other trials in Czechia

Denmark5 sites

  • Aalborg University Hospital /ID# 223220

    Aalborg, North Denmark, 9000

  • Duplicate_Herlev Hospital /ID# 223221

    Herlev, Capital Region, 2730

  • Odense University Hospital /ID# 223217

    Odense, Region Syddanmark, 5000

  • Duplicate_Roskilde Hospital /ID# 223366

    Roskilde, 4000

  • Sygehus Lillebalt, Vejle /ID# 223216

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Ukraine5 sites

  • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943

    Cherkasy, Cherkasy Oblast, 18009

  • Communal non-profit enterprise Regional Center of Oncology /ID# 223945

    Kharkiv, Kharkiv Oblast, 61070

  • MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942

    Khmelnytskyi, 29000

  • National Cancer Institute /ID# 223944

    Kyiv, 03022

  • SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941

    Lviv, 79044

Other trials in Ukraine

Canada4 sites

  • Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846

    Calgary, Alberta, T2N 5G2

  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 218883

    Halifax, Nova Scotia, B3H 2Y9

  • CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887

    Lévis, Quebec, G6V 3Z1

  • BC Cancer - Vancouver /ID# 222804

    Vancouver, British Columbia, V5Z 1L3

Other trials in Canada

Sweden4 sites

  • Sodra Alvsborgs sjukhus /ID# 213061

    Borås, Västra Götaland County, 501 82

  • Duplicate_Universitetssjukhuset Linköping /ID# 200789

    Linkoping, Västra Götaland County, 581 85

  • Sunderby sjukhus /ID# 201314

    Luleå, Norrbotten County, 971 80

  • Uddevalla sjukhus /ID# 201315

    Uddevalla, Västra Götaland County, 451 80

Other trials in Sweden

Singapore3 sites

  • National University Hospital /ID# 203988

    Singapore, 119228

  • Singapore General Hospital /ID# 202131

    Singapore, 169608

  • Tan Tock Seng Hospital /ID# 204374

    Singapore, 308433

Other trials in Singapore

About this study

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

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.

Keywords
Cancer, Multiple Myeloma (MM), Relapsed or Refractory Multiple Myeloma (R/R MM), pharmacokinetics, CANOVA
Medical subject headings
Multiple Myeloma, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03539744
Study groupRoleWhat they receive
Arm 1 VenDexExperimentalVenetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Receives: Drug: Dexamethasone; Drug: Venetoclax
Arm 2 PomDexActive comparatorPomalidomide 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.
Receives: Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 43 months from first randomization

Secondary outcomes (17)

  1. 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.

    Measured: Up to approximately 43 months from first randomization

  2. 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.

    Measured: Up to approximately 43 months from first randomization

  3. 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.

    Measured: Up to approximately 51 months from first randomization

  4. 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).

    Measured: Up to approximately 43 months from first randomization

  5. 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).

    Measured: Up to approximately 51 months from first randomization

  6. 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).

    Measured: Up to approximately 51 months from first randomization

  7. Change from Baseline in PROMIS Fatigue Score

    Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.

    Measured: Up to approximately 51 months from first randomization

  8. Change from Baseline in BPI-SF Worst Pain Score

    Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.

    Measured: Up to approximately 51 months from first randomization

  9. 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."

    Measured: Up to approximately 51 months from first randomization

  10. 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).

    Measured: Up to approximately 51 months from first randomization

  11. 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.

    Measured: Up to approximately 51 months from first randomization

  12. 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.

    Measured: Up to approximately 43 months from first randomization

  13. 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.

    Measured: Up to approximately 43 months from first randomization

  14. 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).

    Measured: Up to approximately 43 months from first randomization

  15. Cmax of Venetoclax

    Maximum plasma concentration (Cmax) of venetoclax

    Measured: Up to approximately 225 days from initial dose

  16. Trough Concentration (Ctrough) of Venetoclax

    Observed plasma concentration at trough (Ctrough) of venetoclax.

    Measured: Up to approximately 225 days from initial dose

  17. 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.

    Measured: Up to approximately 51 months from first randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2018
  2. Study start22 Oct 2018
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03539744
Sponsor's protocol ID
M13-494
Other IDs
2023-506112-40, 2023
Status last verified
Jun 2025
First submitted
17 May 2018
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Popat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, Kapoor P, Katodritou E, Kortum KM, Ling S, Nagarajan C, Suzuki K, Qiu L, Onishi M, Ku G, Dail M, Mukherjee N, Ross JA, Badawi MA, Fusco MJ, Dobkowska E, Arriola E, Bueno OF, Bahlis NJ, Iida S, Moreau P, Valent J, Mateos MV. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2026 Jan 20;44(3):164-175. doi: 10.1200/JCO-25-00924. Epub 2025 Dec 10.

    PubMed 41370738

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pomalidomide, Dexamethasone and Venetoclax in people with Multiple Myeloma, run by AbbVie at 180 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in China, United States, Japan, Spain, United Kingdom and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 43 months from first randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03539744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in