Multiple Myeloma Clinical Trial

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.

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

265

Study ID:

NCT03539744

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 178 Locations for this study

See Locations Near You

University of Arizona Cancer Center - North Campus /ID# 218407
Tucson Arizona, 85719, United States
VA Central California Health Care System /ID# 200047
Fresno California, 93703, United States
University of California, Los Angeles /ID# 171524
Los Angeles California, 90095, United States
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
Aurora Colorado, 80045, United States
Mayo Clinic /ID# 200075
Jacksonville Florida, 32224, United States
Cleveland Clinic Florida /ID# 208884
Weston Florida, 33331, United States
Duplicate_Norton Cancer Institute /ID# 200834
Louisville Kentucky, 40202, United States
University of Maryland Medical Center /ID# 217422
Baltimore Maryland, 21201, United States
Boston Medical Center /ID# 223606
Boston Massachusetts, 02118, United States
Barbara Ann Karmanos Cancer In /ID# 201377
Detroit Michigan, 48201, United States
Henry Ford Hospital /ID# 171531
Detroit Michigan, 48202, United States
Mayo Clinic - Rochester /ID# 201091
Rochester Minnesota, 55905, United States
Columbia University Medical Center /ID# 200715
New York New York, 10032, United States
Fairview Hospital - Moll Pavilion /ID# 208919
Cleveland Ohio, 44111, United States
Cleveland Clinic Main Campus /ID# 202247
Cleveland Ohio, 44195, United States
UPMC Hillman Cancer Ctr /ID# 200063
Pittsburgh Pennsylvania, 15232, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 200060
Houston Texas, 77030, United States
Huntsman Cancer Institute /ID# 218406
Salt Lake City Utah, 84112, United States
VA Puget Sound Health Care System /ID# 222708
Seattle Washington, 98108, United States
Liverpool Hospital /ID# 202431
Liverpool New South Wales, 2170, Australia
Sydney Adventist Hospital /ID# 222874
Wahroonga New South Wales, 2076, Australia
Wollongong Hospital /ID# 205545
Wollongong New South Wales, 2500, Australia
ICON Cancer Care - Townsville /ID# 206565
Hyde Park Queensland, 4812, Australia
Icon Cancer Centre /ID# 205663
South Brisbane Queensland, 4101, Australia
The Queen Elizabeth Hospital /ID# 202432
Woodville South South Australia, 5011, Australia
Perth Blood Institute Ltd /ID# 206649
Nedlands Western Australia, 6009, Australia
Tom Baker Cancer Centre /ID# 218846
Calgary Alberta, T2N 4, Canada
BC Cancer - Vancouver /ID# 222804
Vancouver British Columbia, V5Z 1, Canada
QE II Health Sciences Centre /ID# 218883
Halifax Nova Scotia, B3H 1, Canada
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
Levis Quebec, G6V 3, Canada
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
Beijing Beijing, 10002, China
Peking University Third Hospital /ID# 216371
Beijing Beijing, 10019, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040
Beijing Beijing, 10073, China
Sun Yat-Sen University Cancer Center /ID# 223828
Guangzhou Guangdong, 51006, China
Guangdong Provincial People's Hospital /ID# 215860
Guangzhou Guangdong, 51008, China
Henan Cancer Hospital /ID# 215987
Zhengzhou Henan, 45000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850
Wuhan Hubei, 43002, China
Nanjing Drum Tower Hospital /ID# 223143
Nanjing Jiangsu, 21000, China
The First Affiliated Hospital of Soochow University /ID# 216094
Suzhou Jiangsu, 21500, China
The First Affiliated Hospital of Nanchang University /ID# 216954
Nanchang Jiangxi, 33000, China
The First Hospital of China Medical University /ID# 215996
Shenyang Liaoning, 11000, China
Shengjing Hospital of China Medical University /ID# 223435
Shenyang Liaoning, 11002, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643
Shanghai Shanghai, 20006, China
Shanghai Tongji Hospital /ID# 218865
Shanghai Shanghai, 20006, China
West China Hospital, Sichuan University /ID# 216647
Chengdu Sichuan, 61004, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041
Tianjin Tianjin, 30002, China
Tianjin Medical University Cancer Institute & Hospital /ID# 223550
Tianjin Tianjin, 30006, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989
Hangzhou Zhejiang, 31000, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691
Hangzhou Zhejiang, 31000, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 218953
Wenzhou Zhejiang, 32500, China
Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033
Beijing , 10004, China
Fakultni nemocnice Brno /ID# 204512
Brno , 613 0, Czechia
Fakultni nemocnice Hradec Kralove /ID# 221291
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc /ID# 221290
Olomouc , 779 0, Czechia
Fakultni Nemocnice Ostrava /ID# 204515
Ostrava , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 221166
Praha , 128 0, Czechia
Duplicate_Herlev Hospital /ID# 223221
Herlev Hovedstaden, 2730, Denmark
Aalborg University Hospital /ID# 223220
Aalborg Nordjylland, 9000, Denmark
Odense University Hospital /ID# 223217
Odense Syddanmark, 5000, Denmark
Sygehus Lillebalt, Vejle /ID# 223216
Vejle Syddanmark, 7100, Denmark
Duplicate_Roskilde Hospital /ID# 223366
Roskilde , 4000, Denmark
Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182
La Tronche Isere, 38700, France
CHU Reims - Hôpital Robert Debre /ID# 233907
Reims CEDEX Marne, 51092, France
CHRU Nancy - Hopitaux de Brabois /ID# 201076
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
CHRU Lille - Hopital Claude Huriez /ID# 202213
Lille Nord, 59037, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 202211
Creteil Paris, 94010, France
CHU de Nantes, Hotel Dieu -HME /ID# 200099
Nantes Pays-de-la-Loire, 44000, France
HCL - Hopital Lyon Sud /ID# 200097
Pierre Benite CEDEX Rhone, 69495, France
CH Henri Duffaut /ID# 234154
Avignon CEDEX 9 Vaucluse, 84902, France
Hopital Pitie Salpetriere /ID# 214173
Paris , 75013, France
Centre Henri Becquerel /ID# 223186
Rouen , 76038, France
Robert-Bosch-Krankenhaus /ID# 223947
Stuttgart Baden-Wuerttemberg, 70736, Germany
Universitaetsklinikum Tuebingen /ID# 238646
Tubingen Baden-Wuerttemberg, 72076, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
Kiel Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Jena /ID# 201254
Jena Thueringen, 07747, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
Berlin , 12203, Germany
Klinikum Chemnitz gGmbH /ID# 233797
Chemnitz , 09116, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 215495
Hamburg , 20246, Germany
Asklepios Klinik Altona /ID# 222506
Hamburg , 22763, Germany
Universitaetsklinikum Wuerzburg /ID# 200055
Wuerzburg , 97080, Germany
Alexandra General Hospital /ID# 202386
Athens Attiki, 11528, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 222879
Heraklion Kriti, 71500, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
Athens , 10676, Greece
University Gen Hosp of Patra /ID# 201691
Patras , 26504, Greece
Theageneio Anticancer Hospital /ID# 213983
Thessaloniki , 54639, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 201692
Thessaloniki , 57010, Greece
Rambam Health Care Campus /ID# 169678
Haifa H_efa, 31096, Israel
Bnai Zion Medical Center /ID# 169466
Haifa H_efa, 33394, Israel
The Lady Davis Carmel Medical Center /ID# 222969
Haifa H_efa, 34362, Israel
Assuta Ashdod Medical Center /ID# 222968
Ashdod HaDarom, 77476, Israel
Soroka University Medical Center /ID# 218768
Be'er Sheva HaDarom, 84439, Israel
The Chaim Sheba Medical Center /ID# 169778
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 169437
Tel Aviv Tel-Aviv, 64239, Israel
Hadassah /ID# 169474
Jerusalem Yerushalayim, 91120, Israel
Rabin Medical Center /ID# 244611
Haifa , 49414, Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 170950
Torette Ancona, 60020, Italy
AOU Citta della Salute e della Scienza di Torino /ID# 170962
Torino Piemonte, 10126, Italy
Irccs-Crob /Id# 170955
Rionero in Vulture Potenza, 85028, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952
Bologna , 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498
Milan , 20122, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988
Palermo , 90146, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 170948
Terni , 05100, Italy
Nagoya City University Hospital /ID# 170880
Nagoya shi Aichi, 467-8, Japan
The Jikei University Kashiwa Hospital /ID# 223031
Kashiwa-shi Chiba, 277-8, Japan
Kyushu University Hospital /ID# 171117
Fukuoka-shi Fukuoka, 812-8, Japan
Ogaki Municipal Hospital /ID# 171043
Ogaki-shi Gifu, 503-8, Japan
Gunma University Hospital /ID# 170966
Maebashi-shi Gunma, 371-8, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
Hiroshima-shi Hiroshima, 730-8, Japan
Kobe City Medical Center General Hospital /ID# 170992
Kobe-shi Hyogo, 650-0, Japan
National Hospital Organization Mito Medical Center /ID# 171187
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
Hitachi General Hospital /ID# 200843
Hitachi-shi Ibaraki, 317-0, Japan
Iwate Medical University Hospital /ID# 222849
Shiwa-gun Iwate, 028-3, Japan
Tohoku University Hospital /ID# 201935
Sendai-shi Miyagi, 98085, Japan
Okayama Medical Center /ID# 200119
Okayama-shi Okayama, 701-1, Japan
Japanese Red Cross Osaka Hospital /ID# 171493
Osaka-shi Osaka, 543-8, Japan
Osaka University Hospital /ID# 201966
Suita-shi Osaka, 565-0, Japan
Tokushima University Hospital /ID# 202571
Tokushima-shi Tokushima, 770-8, Japan
The Jikei University Hospital /ID# 239014
Minato-ku Tokyo, 105-8, Japan
Japanese Red Cross Medical Center /ID# 171256
Shibuya-ku Tokyo, 150-8, Japan
Yamagata University Hospital /ID# 238329
Yamagata-shi Yamagata, 990-9, Japan
Duplicate_Gachon University Gil Medical Center /ID# 202827
Incheon Gyeonggido, 21565, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 202709
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 234045
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Ulsan University Hospital /ID# 222716
Ulsan Ulsan Gwang Yeogsi, 44033, Korea, Republic of
Seoul National University Hospital /ID# 202711
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 202710
Seoul , 06351, Korea, Republic of
Moscow State budget healthcare /ID# 169685
Moscow Moskva, 12528, Russian Federation
Research Institute of Fundamental and Clinical Immunology /ID# 223594
Novosibirsk Novosibirskaya Oblast, 63009, Russian Federation
LLC Novaya Klinika /ID# 169689
Pyatigorsk Stavropol Skiy Kray, 35750, Russian Federation
City Clinical Hospital #52 /ID# 206289
Moscow , 12318, Russian Federation
Leningrad Regional Clinical Hospital /ID# 202776
Saint Petersburg , 19429, Russian Federation
Almazov National Medical Research Centre /ID# 169681
Sankt-Peterburg , 19734, Russian Federation
Tula Regional Clinical Hospital /ID# 223226
Tula , 30005, Russian Federation
National University Hospital /ID# 203988
Singapore , 11922, Singapore
Singapore General Hospital /ID# 202131
Singapore , 16960, Singapore
Tan Tock Seng Hospital /ID# 204374
Singapore , 30843, Singapore
Hospital Universitari Son Espases /ID# 222889
Palma de Mallorca Illes Balears, 07120, Spain
Hospital Costa del Sol /ID# 234083
Marbella Malaga, 29603, Spain
Complejo Hospitalario Universitario Ourense /ID# 222876
Orense Ourense, 32005, Spain
Hospital Universitario Canarias /ID# 238452
San Cristóbal de La Laguna Santa Cruz De Tenerife, 38320, Spain
Hospital Universitario Vall d'Hebron /ID# 218106
Barcelona , 08035, Spain
Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
Girona , 17007, Spain
Hospital de Leon /ID# 233878
Leon , 24071, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 171288
Madrid , 28041, Spain
Hospital Universitario La Paz /ID# 218107
Madrid , 28046, Spain
Hospital Universitario de Salamanca /ID# 171294
Salamanca , 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 171286
Sevilla , 41013, Spain
Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887
Toledo , 45007, Spain
Hospital Universitario y Politecnico La Fe /ID# 234019
Valencia , 46026, Spain
Sunderby sjukhus /ID# 201314
Lulea Norrbottens Lan, 971 8, Sweden
Sodra Alvsborgs sjukhus /ID# 213061
Boras Vastra Gotalands Lan, 501 8, Sweden
Duplicate_Universitetssjukhuset Linköping /ID# 200789
Linkoping Vastra Gotalands Lan, 581 8, Sweden
Uddevalla sjukhus /ID# 201315
Uddevalla Vastra Gotalands Lan, 451 8, Sweden
Cukurova Universitesi Tip Fakultesi /ID# 201955
Saricam Adana Adana, 01330, Turkey
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
Karsiyaka Izmir, 35575, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
Ankara , 06200, Turkey
Gazi University Medical Faculty /ID# 222698
Ankara , 06560, Turkey
Ankara Univ Medical Faculty /ID# 201881
Ankara , 06590, Turkey
Istanbul University Istanbul Medical Faculty /ID# 201953
Istanbul , 34093, Turkey
Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
Istanbul , 34214, Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
Istanbul , 34899, Turkey
Ege University Medical Faculty /ID# 222697
Izmir , 35040, Turkey
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
Cherkasy , 18009, Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 223945
Kharkiv , 61070, Ukraine
MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942
Khmelnytskyi , 29000, Ukraine
National Cancer Institute /ID# 223944
Kyiv , 03022, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
Lviv , 79044, Ukraine
Addenbrooke's Hospital /ID# 223097
Cambridge Cambridgeshire, CB2 2, United Kingdom
Imperial College London - St Mary's Hospital /ID# 171446
London London, City Of, W2 1N, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
Norwich Norfolk, NR4 7, United Kingdom
Duplicate_Nottingham University Hospitals NHS Trust /ID# 223292
Nottingham Nottinghamshire, NG5 1, United Kingdom
NHS Greater Glasgow and Clyde /ID# 202199
Glasgow Scotland, G12 0, United Kingdom
University Hospitals of North Midlands NHS Trust /ID# 218355
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 171428
London , NW1 2, United Kingdom
Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
London , SE13 , United Kingdom
Manchester University NHS Foundation Trust /ID# 171440
Manchester , M9 2A, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 171444
Portsmouth , PO6 3, United Kingdom
Royal Berkshire NHS Foundation Trust /ID# 217835
Reading , RG1 5, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447
Sheffield , S5 7A, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

265

Study ID:

NCT03539744

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.