Spots Global Cancer Trial Database for Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
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Trial Identification
Brief Title: Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Official Title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Study ID: NCT04975997
Conditions
Study Description
Brief Summary: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
Detailed Description: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B). In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms: * Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd) * Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd) Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment. The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Genesis cancer and Blood Institute (GCBI) - Sarah Cannon, Hot Springs, Arkansas, United States
Local Institution - 683, Corona, California, United States
Compassionate Cancer Care Medical Group Inc., Fountain Valley, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Local Institution - 684, Newport, California, United States
Yale University School Of Medicine, New Haven, Connecticut, United States
Local Institution - 029, Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Local Institution - 028, Saint Petersburg, Florida, United States
BRCR Global, Tamarac, Florida, United States
Local Institution - 034, West Palm Beach, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Local Institution - 040, Louisville, Kentucky, United States
Christus St Francis Cabrini Hospital, Alexandria, Louisiana, United States
Local Institution - 682, Baton Rouge, Louisiana, United States
Local Institution - 027, Baton Rouge, Louisiana, United States
Center For Cancer And Blood Disorders, Bethesda, Maryland, United States
Local Institution - 010, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
HCA Midwest Health, Kansas City, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Local Institution - 015, Summit, New Jersey, United States
Local Institution - 042, Bay Shore, New York, United States
Duke University Hospital, Durham, North Carolina, United States
TriHealth, Good Samaritan Hospital, Cincinnati, Ohio, United States
MetroHealth Medical Center - Main Campus, Cleveland, Ohio, United States
Cleveland Clinic - Taussig Cancer Institute, Cleveland, Ohio, United States
Ohio Health Corporation, Columbus, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute (SCRI), Nashville, Tennessee, United States
University Of Wisconsin, Madison, Wisconsin, United States
Local Institution - 080, Ciudad Autanoma De Buenos Aires, Buenos Aires, Argentina
Local Institution - 083, Villa Elisa, Buenos Aires, Argentina
Local Institution - 813, Birtinya, Queensland, Australia
The Townsville Hospital, Douglas, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Dept Of Oncology, Bedford Park, South Australia, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Epworth Hospital, East Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Perth Blood Institute, West Perth, Western Australia, Australia
Royal Prince Alfred Hospital, Camperdown, , Australia
St Vincent's Hospital Melbourne, Fitzroy, , Australia
The Canberra Hospital, Garran, , Australia
Medical University of Graz, Graz, , Austria
Krankenhaus Der Barmherzigen Schwestern Linz, Linz, , Austria
Universitatsklinik der PMU, Salzburg, , Austria
University Hospital St. Poelten, St Polten, , Austria
Medizinische Universität Wien, Vienna, , Austria
Local Institution - 151, Wien, , Austria
Local Institution - 157, Wien, , Austria
AZ Sint-Jan AV Brugge, Brugge, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Local Institution - 056, Curitiba, Parana, Brazil
Local Institution - 058, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 050, Porto Alegre, RS, Brazil
Local Institution - 054, Jau, SAO Paulo, Brazil
Local Institution - 051, Barretos, São Paulo, Brazil
Local Institution - 053, Rio de Janeiro, , Brazil
Local Institution - 055, Sao Paulo, , Brazil
Local Institution - 057, Sao Paulo, , Brazil
Local Institution - 052, Sao Paulo, , Brazil
Local Institution - 111, Calgary, Alberta, Canada
Local Institution - 103, Edmonton, Alberta, Canada
BC Cancer Agency, Fraser Valley Center, Surrey, British Columbia, Canada
Local Institution - 104, Saint John, New Brunswick, Canada
Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center, St John's, Newfoundland and Labrador, Canada
Queen Elizabeth Ii Health Sciences Centre, Halifax, Nova Scotia, Canada
Local Institution - 109, Ottawa, Quebec, Canada
Local Institution - 107, Saskatoon, Saskatchewan, Canada
CHU de Quebec-Universite Laval, Quebec, , Canada
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Local Institution - 143, Xian, Shaanxi, China
Shanghai Fourth People's hospital, Shanghai, Shanghai, China
Shanxi Bethune Hospital, Taiyuan, Shanxi, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Beijing Boren Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Peking Union Medical College Hospital, Beijing, , China
First Hospital of Jilin University, Changchun, , China
Beijing Chaoyang Hospital Capital Medical University, Chaoyang District, , China
Guangdong General Hospital, Guangzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou City, , China
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, Zhejiang, , China
The First Affiliated Hospital Of Harbin Medical University, Harbin, , China
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, , China
Ruijin Hospital Shanghai Jiaotong University, Shanghai, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Shengjing Hospital Of China Medical University, Shenyang, , China
The First Affiliated Hospital Of Soochow University, Suzhu, , China
Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences, Tianjin, , China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
Xijing Hospital, Xian, , China
Henan Cancer Hospital, Zhengzhou, , China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Ostrava, Ostrava-Poruba, , Czechia
Vseobecna Fakultni Nemocnice V Praze, Prague 2, , Czechia
Aalborg Universitetshospital, Aalborg, , Denmark
Odense University Hospital, Odense, , Denmark
Sealand University Hospital, Roskilde, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Oulu University Hospital, Oulu, , Finland
Turku University Hospital, Turku, , Finland
CH Argenteuil Victor Dupouy, Argenteuil, , France
Centre Hospitalier Departemental de Vendee, La Roche -Sur-Yon - Cedex 9, , France
CHRU de Lille France, Lille Cedex, , France
CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage, Nancy Cedex, , France
Local Institution - 454, Nantes, , France
Hopital Saint-Louis, Paris Cedex, , France
Hopital Saint Antoine, Paris, , France
Chu Bordeaux, Pessac, , France
Centre Henri Becquerel, Rouen, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse Cedex 9, , France
Uniklinik Schleswig-Holstein Kiel, Kiel, Schleswig-Holstein, Germany
Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main, , Germany
Universitaetsklinik Hamburg - Eppendorf, Hamburg, , Germany
Asklepios Altona, Hamburg, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitatsklinikum Schleswig-Holstein, Lubeck, , Germany
University General Hospital of Patras, Patras, Achaea, Greece
Olympion Clinic, Patra, Achaia, Greece
Alexandra General Hospital Of Athens, Athens, , Greece
Theagenio Anticancer Hospital of Thessaloniki, Thessaloniki, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki, , Greece
Local Institution - 932, Hyderabad, Andhra Pradesh, India
M. S. Ramaiah Medical College And Hospital, Bangalore, Karnataka, India
Local Institution - 934, Ernakulam, Kerala, India
Mumbai Oncocare Centre Vile Parle, Mumbai, Maharashtra, India
Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India
Jawaharlal Institute of Postgraduate Medical Education & Research, Pondicherry, , India
Cork University Hospital, Cork, , Ireland
Beaumont Hospital, Dublin 9, , Ireland
University Hospital Galway, Galway, , Ireland
Local Institution - 874, Afula, HaZafon, Israel
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Sheba Medical Center - PPDS, Tel Hashomer, , Israel
Local Institution - 415, Roma, Lazio, Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna, , Italy
Università di Catania- Presidio Ospedaliero Ferrarotto, Catania, , Italy
A.O.U. San Martino, Genova, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, , Italy
Local Institution - 407, Milano, , Italy
A.O.U. Maggiore della Carit, Novara, , Italy
Fondazione Irccs Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Local Institution - 405, Reggio Calabria, , Italy
Local Institution - 413, Reggio Emilia, , Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza, Roma, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo FG, , Italy
Local Institution - 409, Terni, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine, Udine, , Italy
Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan
Local Institution - 917, Higashi-Ibaraki-gun, Ibaraki, Japan
Local Institution - 919, Shimotsuga, Tochigi, Japan
Local Institution - 920, Nerima-ku, Tokyo, Japan
Local Institution - 918, Shinagawa-ku, Tokyo, Japan
University of Yamanashi Hospital, Chuo-shi, Yamanashi, Japan
Aomori Prefectural Central Hospital, Aomori, , Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
Kameda General Hospital, Kamogawa, , Japan
University Hospital,Kyoto Prefectural University of Medicine, Kyoto-City, , Japan
Aichi Cancer Center, Nagoya, , Japan
Nagoya City University Hospital, Nagoya, , Japan
Okayama Medical Center, Okayama, , Japan
Kindai University Hospital- Osakasayama Campus, Osaka-Sayama, , Japan
Osaka Metropolitan university Hospital, Osaka, , Japan
Sapporo Hokuyu Hospital, Sapporo, , Japan
Tohoku University Hospital, Sendai, , Japan
Japan Red Cross Medical Center, Shibuya-ku, , Japan
NTT Medical Center Tokyo, Shinagawa-ku, Tokyo, , Japan
Toyohashi Municipal Hospital, Toyohashi, , Japan
Kyungpook National University Hospital, Daegu, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Hwasun Chonnam National University Hospital, Hwasun-gun, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul - Saint Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Local Institution - 182, Mexico City, Distrito Federal, Mexico
Local Institution - 183, Guadalajara, Jalisco, Mexico
Local Institution - 181, La Raza, , Mexico
Local Institution - 180, Mexico City, , Mexico
Albert Schweitzer Ziekenhuis, Dordrecht, Zuid-Holland, Netherlands
Vrije Universiteit Medisch Centrum (Vumc), Amsterdam, , Netherlands
Hagaziekenhuis, Den Haag, , Netherlands
Haukeland University Hospital, Bergen, , Norway
Oslo Myeloma Center - PPDS, Oslo, , Norway
St. Olav's University Hospital, Trondheim, , Norway
Uniwersytecki Szpital Kliniczny w Białymstoku, Bialystok, Podlaskie, Poland
Szpital Uniwersytecki W Krakowie, Krakow, , Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu, Nowy Sacz, , Poland
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan, , Poland
Specjalistyczny Szpital im. dra Alfreda Sokolowskiego, Walbrzych, , Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warszawa, , Poland
Centro Hospital e Universitario de Coimbra, Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, Lisboa, , Portugal
Champalimaud Cancer Center, Lisboa, , Portugal
Ipo Instituto Portugues De Oncologia Porto, Porto, , Portugal
Centro Hospitalar de Sao Joao, EPE, Porto, , Portugal
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall D hebron - PPDS, Barcelona, , Spain
Hospital Universitari Germans Trias I Pujol, Barcelona, , Spain
Hospital San Pedro de Alcántara, Caceres, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital De La Princesa, Madrid, , Spain
Clinica Universidad de Navarra-Madrid, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Virgen De La Victoria, Malaga, , Spain
Hospital Universitario Virgen de La Arrixaca, Murcia, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Clinico Universitario De Santiago, Santiago de Compostela, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Sodra Alvsborgs Sjukhus Boras, Boras, , Sweden
Helsingborgs Lasarett, Helsingborg, , Sweden
Kantonsspital Graubunden, Chur, , Switzerland
Kantonsspital St. GallenBereich OnkologieHamatologie, St. Gallen, , Switzerland
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital, Niao-Sung Hsiang Kaohsiung County, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, Taiana, , Taiwan
National Taiwan University Hospital, Taipei, Zhongzheng Dist., , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation, Linkou Memorial Hospital, Taoyuan City, , Taiwan
Liv Hospital Ankara, Kavaklıdere, Ankara, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi, Yenimahalle, Ankara, Turkey
Marmara University Pendik Training and Research Hospital, Pendik, Istanbul, Turkey
Dokuz Eylul University Medical Faculty, Balçova, Izmir, Turkey
Ege University Medical Faculty, Bornova, Izmir, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun, Kurupelit, Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Gazi University Faculty Of Medicine, Gaziantep, , Turkey
Erciyes University Medical Faculty, Kayseri, , Turkey
Local Institution - 702, Nottingham, Nottinghamshire, United Kingdom
Belfast City Hospital, Belfast Northern Ireland, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital, Birmingham, , United Kingdom
Kent and Canterbury Hospital, Canterbury Kent, , United Kingdom
Local Institution - 704, Lancashire Blackpool, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Guy's and St Thomas' Hospital - London, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre, Oxford, , United Kingdom
Local Institution - 711, Portsmouth, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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