Multiple Myeloma Clinical Trial

A Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Participants With 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 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 MM positive for t(11;14).
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:

244

Study ID:

NCT03539744

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 178 Locations for this study

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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 More Info
Site Coordinator
Contact
844-663-3742
Norton Cancer Institute /ID# 200834
Louisville Kentucky, 40202, United States
University of Maryland School of Medicine /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 More Info
Site Coordinator
Contact
844-663-3742
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 More Info
Site Coordinator
Contact
844-663-3742
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 /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
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
Shengjing Hospital of China Medical University /ID# 223435
Shenyang , 11002, China
Fakultni Nemocnice Brno /ID# 204512
Brno , 625 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
Herlev Hospital /ID# 223221
Herlev Hovedstaden, 2730, Denmark
Aalborg University Hospital /ID# 223220
Aalborg Nordjylland, 9000, Denmark
Sygehus Lillebælt, Vejle /ID# 223216
Vejle Syddanmark, 7100, Denmark
Odense Universitets Hospital /ID# 223217
Odense C , 5000, Denmark
Roskilde Hospital /ID# 223366
Roskilde , 4000, Denmark
HCL - Hopital Lyon Sud /ID# 200097
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
CHRU Lille - Hopital Claude Huriez /ID# 202213
Lille Hauts-de-France, 59037, 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
CHU de Nantes, Hotel Dieu -HME /ID# 200099
Nantes Pays-de-la-Loire, 44000, France
CH Henri Duffaut /ID# 234154
Avignon CEDEX 9 Provence-Alpes-Cote-d Azur, 84902, France
Hopital Henri Mondor /ID# 202211
Creteil , 94000, France
CHU Grenoble - Hopital Michallon /ID# 223182
La Tronche , 38700, 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 (UKE) /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
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-Yafo Tel-Aviv, 64239, Israel
Assuta Ashdod Medical Center /ID# 222968
Ashdod , 77476, Israel
Rambam Health Care Campus /ID# 169678
Haifa , 31096, Israel
Bnai Zion Medical Center /ID# 169466
Haifa , 33394, Israel
The Lady Davis Carmel Medical Center /ID# 222969
Haifa , 34362, Israel
Hadassah /ID# 169474
Jerusalem , 91120, Israel
Rabin Medical Center /ID# 244611
Petakh Tikva , 49414, Israel
Irccs-Crob /Id# 170955
Rionero in Vulture Potenza, 85028, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950
Ancona , 60126, 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
A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962
Turin , 10126, 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
Yonsei University Health System Severance Hospital /ID# 202709
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Gachon University Gil Medical Center /ID# 202827
Incheon , 21565, Korea, Republic of
Seoul National University Hospital /ID# 202711
Seoul , 03080, Korea, Republic of
Samsung Medical Center /ID# 202710
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045
Seoul , 06591, Korea, Republic of
Ulsan University Hospital /ID# 222716
Ulsan , 44033, 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
Khmelnytskyi Regional Hospital /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
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
Norwich Norfolk, NR4 7, United Kingdom
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
Cambridge University Hospitals NHS Foundation Trust /ID# 223097
Cambridge , CB2 0, 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
Imperial College Healthcare NHS Trust /ID# 171446
London , W2 1N, United Kingdom
Manchester University NHS Foundation Trust /ID# 171440
Manchester , M13 9, 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:

244

Study ID:

NCT03539744

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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