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.
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.
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There are 178 Locations for this study
Tucson Arizona, 85719, United States
Fresno California, 93703, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Jacksonville Florida, 32224, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02118, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
New York New York, 10032, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Liverpool New South Wales, 2170, Australia
Wahroonga New South Wales, 2076, Australia
Wollongong New South Wales, 2500, Australia
Hyde Park Queensland, 4812, Australia
South Brisbane Queensland, 4101, Australia
Woodville South South Australia, 5011, Australia
Nedlands Western Australia, 6009, Australia
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 1, Canada
Halifax Nova Scotia, B3H 1, Canada
Levis Quebec, G6V 3, Canada
Beijing Beijing, 10002, China
Beijing Beijing, 10019, China
Beijing Beijing, 10073, China
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51008, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Nanchang Jiangxi, 33000, China
Shenyang Liaoning, 11000, China
Shanghai Shanghai, 20006, China
Shanghai Shanghai, 20006, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30002, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Wenzhou Zhejiang, 32500, China
Beijing , 10004, China
Shenyang , 11002, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Ostrava , 708 5, Czechia
Praha , 128 0, Czechia
Herlev Hovedstaden, 2730, Denmark
Aalborg Nordjylland, 9000, Denmark
Odense C Syddanmark, 5000, Denmark
Vejle Syddanmark, 7100, Denmark
Roskilde , 4000, Denmark
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Lille Hauts-de-France, 59037, France
Reims CEDEX Marne, 51092, France
Vandoeuvre-les-Nancy Meurthe-et-Moselle, 54500, France
Nantes Pays-de-la-Loire, 44000, France
Avignon CEDEX 9 Vaucluse, 84902, France
Creteil , 94000, France
La Tronche , 38700, France
Paris , 75013, France
Rouen , 76038, France
Stuttgart Baden-Wuerttemberg, 70736, Germany
Tubingen Baden-Wuerttemberg, 72076, Germany
Kiel Schleswig-Holstein, 24105, Germany
Jena Thueringen, 07747, Germany
Berlin , 12203, Germany
Chemnitz , 09116, Germany
Hamburg , 20246, Germany
Hamburg , 22763, Germany
Wuerzburg , 97080, Germany
Athens Attiki, 11528, Greece
Heraklion Kriti, 71500, Greece
Athens , 10676, Greece
Patras , 26504, Greece
Thessaloniki , 54639, Greece
Thessaloniki , 57010, Greece
Be'er Sheva HaDarom, 84439, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Ashdod , 77476, Israel
Haifa , 31096, Israel
Haifa , 33394, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Petakh Tikva , 49414, Israel
Rionero in Vulture Potenza, 85028, Italy
Ancona , 60126, Italy
Bologna , 40138, Italy
Milan , 20122, Italy
Palermo , 90146, Italy
Terni , 05100, Italy
Turin , 10126, Italy
Nagoya shi Aichi, 467-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Ogaki-shi Gifu, 503-8, Japan
Maebashi-shi Gunma, 371-8, Japan
Hiroshima-shi Hiroshima, 730-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
Hitachi-shi Ibaraki, 317-0, Japan
Shiwa-gun Iwate, 028-3, Japan
Sendai-shi Miyagi, 98085, Japan
Okayama-shi Okayama, 701-1, Japan
Osaka-shi Osaka, 543-8, Japan
Suita-shi Osaka, 565-0, Japan
Tokushima-shi Tokushima, 770-8, Japan
Minato-ku Tokyo, 105-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Moscow Moskva, 12528, Russian Federation
Novosibirsk Novosibirskaya Oblast, 63009, Russian Federation
Pyatigorsk Stavropol Skiy Kray, 35750, Russian Federation
Moscow , 12318, Russian Federation
Saint Petersburg , 19429, Russian Federation
Sankt-Peterburg , 19734, Russian Federation
Tula , 30005, Russian Federation
Singapore , 11922, Singapore
Singapore , 16960, Singapore
Singapore , 30843, Singapore
Palma de Mallorca Illes Balears, 07120, Spain
Marbella Malaga, 29603, Spain
Orense Ourense, 32005, Spain
San Cristóbal de La Laguna Santa Cruz De Tenerife, 38320, Spain
Barcelona , 08035, Spain
Girona , 17007, Spain
Leon , 24071, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Salamanca , 37711, Spain
Sevilla , 41013, Spain
Toledo , 45007, Spain
Valencia , 46026, Spain
Lulea Norrbottens Lan, 971 8, Sweden
Boras Vastra Gotalands Lan, 501 8, Sweden
Linkoping Vastra Gotalands Lan, 581 8, Sweden
Uddevalla Vastra Gotalands Lan, 451 8, Sweden
Saricam Adana Adana, 01330, Turkey
Karsiyaka Izmir, 35575, Turkey
Ankara , 06200, Turkey
Ankara , 06560, Turkey
Ankara , 06590, Turkey
Istanbul , 34093, Turkey
Istanbul , 34214, Turkey
Istanbul , 34899, Turkey
Izmir , 35040, Turkey
Cherkasy , 18009, Ukraine
Kharkiv , 61070, Ukraine
Khmelnytskyi , 29000, Ukraine
Kyiv , 03022, Ukraine
Lviv , 79044, Ukraine
Norwich Norfolk, NR4 7, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Cambridge , CB2 0, United Kingdom
London , NW1 2, United Kingdom
London , SE13 , United Kingdom
London , W2 1N, United Kingdom
Manchester , M13 9, United Kingdom
Portsmouth , PO6 3, United Kingdom
Reading , RG1 5, United Kingdom
Sheffield , S5 7A, United Kingdom
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