EXCALIBER-RRMM: Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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:
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Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
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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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone. |
Drug: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Other Names:
Drug: Iberdomide
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
Other Names:
|
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
|
Drug: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Other Names:
Drug: Iberdomide
Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
Other Names:
|
Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
|
Drug: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Other Names:
Drug: Iberdomide
Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
Other Names:
|
Active Comparator: Daratumumab in combination with dexamethasone and bortezomib Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone |
Drug: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
Drug: Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
Other Names:
Drug: Bortezomib
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [Up to approximately 5 years]
To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).
Secondary Outcome Measures
- Overall Survival (OS) [Up to approximately 5 years]
To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).
- Minimal Residual Disease (MRD) negativity rate [Up to approximately 5 years]
Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).
- Overall Response Rate (ORR) [Up to approximately 5 years]
Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.
- Time to response (TTR) [Up to approximately 5 years]
Time from randomization to the first documentation of response (PR or better).
- Duration of Response (DoR) [Up to approximately 5 years]
Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
- Time to Progression (TTP) [Up to approximately 5 years]
The time from randomization to the first documented disease progression.
- Time to Next Treatment (TTNT) [Up to approximately 5 years]
Time from randomization to the start of the next antimyeloma treatment.
- Progression-free Survival 2 (PFS2) [Up to approximately 5 years]
Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.
- Safety [Up to approximately 5 years]
Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
- European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) [Up to approximately 5 years]
Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.
- European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) [Up to approximately 5 years]
EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.
- Recommended iberdomide dose for Stage 2 [Up to approximately 1 year]
- Area under the plasma concentration-time curve from time zero to tau (AUC(TAU)) [Up to approximately 1 year]
- Maximum plasma concentration (Cmax) [Up to approximately 1 year]
- Time to maximum plasma concentration (Tmax) [Up to approximately 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented diagnosis of multiple myeloma (MM) and measurable disease
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Received 1 to 2 prior lines of anti-myeloma therapy
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Must have documented disease progression during or after their last anti-myeloma regimen
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Exclusion Criteria:
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Any condition that confounds the ability to interpret data from the study
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Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
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Known central nervous system involvement with MM
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Prior therapy with iberdomide
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Advent Health | Orlando | Florida | United States | 32804 |
2 | Advent Health | Orlando | Florida | United States | 32804 |
3 | Florida Cancer Specialists North Region Sarah Cannon Research | Saint Petersburg | Florida | United States | 33705 |
4 | Emory University | Atlanta | Georgia | United States | 30322 |
5 | Hematology-Oncology Clinic | Baton Rouge | Louisiana | United States | 70809 |
6 | Center for Cancer And Blood Disorders | Bethesda | Maryland | United States | 20817 |
7 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
8 | UMASS Memorial Hospital | Worcester | Massachusetts | United States | 01655 |
9 | HCA Midwest Health | Kansas City | Missouri | United States | 64132 |
10 | Summit Medical Group Overlook Oncology Center | Summit | New Jersey | United States | 07901 |
11 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
12 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
13 | New York University School of Medicine | New York | New York | United States | 10016 |
14 | New York University School Of Medicine | New York | New York | United States | 10016 |
15 | New York - Presbyterian/Weill Cornell Medical Center | New York | New York | United States | 10021 |
16 | New York - Presbyterian/Weill Cornell Medical Center | New York | New York | United States | 10021 |
17 | Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | United States | 44195 |
18 | Ohio Health Corporation | Columbus | Ohio | United States | 43214 |
19 | West Penn Allegheny Lupus Center of Excellence | Pittsburgh | Pennsylvania | United States | 15212 |
20 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
21 | Tennessee Oncology | Chattanooga | Tennessee | United States | 37404 |
22 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
23 | UT Southwestern Simmons Cancer Center | Dallas | Texas | United States | 75390 |
24 | UT Southwestern Simmons Cancer Center | Dallas | Texas | United States | 75390 |
25 | University Of Wisconsin | Madison | Wisconsin | United States | 53705 |
26 | Local Institution - 032 | Milwaukee | Wisconsin | United States | 53226-3548 |
27 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
28 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
29 | Flinders Medical Centre, Dept Of Oncology | Bedford Park | South Australia | Australia | 5042 |
30 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
31 | Epworth Hospital | East Melbourne | Victoria | Australia | 3001 |
32 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
33 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | 6150 |
34 | Perth Blood Institute | West Perth | Western Australia | Australia | 6005 |
35 | Royal Prince Alfred Hospital | Camperdown | Australia | 2050 | |
36 | Local Institution - 800 | Fitzroy | Australia | 3065 | |
37 | St Vincent's Hospital Melbourne | Fitzroy | Australia | 3065 | |
38 | The Canberra Hospital | Garran | Australia | ACT 2605 | |
39 | Medical University of Graz | Graz | Austria | A-8036 | |
40 | Innsbruck Medical University | Innsbruck | Austria | 6020 | |
41 | Local Institution - 152 | Innsbruck | Austria | 6020 | |
42 | Krankenhaus der Barmherzigen Schwestern Linz | Linz | Austria | 4010 | |
43 | Universitatsklinik der PMU | Salzburg | Austria | 5020 | |
44 | University Hospital St. Poelten | St Polten | Austria | 3100 | |
45 | Medizinische Universitaet Wien | Vienna | Austria | 1090 | |
46 | Wilhelminenspital der Stadt Wien | Wien | Austria | 1160 | |
47 | AZ Sint-Jan AV Brugge | Brugge | Belgium | 8000 | |
48 | Institut Jules Bordet | Brussel | Belgium | 1000 | |
49 | Cliniques Universitaires Saint-Luc | Bruxelles | Belgium | 1200 | |
50 | Centre Hospitalier Universitaire de Liege | Liege | Belgium | 4000 | |
51 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
52 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
53 | BC Cancer Agency, Fraser Valley Center | Surrey | British Columbia | Canada | V3V 1Z2 |
54 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 3L6 |
55 | Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center | St John's | Newfoundland and Labrador | Canada | A1B3V6 |
56 | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
57 | Hamilton Health Sciences Corporation | Hamilton | Ontario | Canada | L8V5C2 |
58 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
59 | Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal | Montreal | Quebec | Canada | H1T 2M4 |
60 | The Ottawa Hospital - General Campus | Ottawa | Quebec | Canada | K1H 8L6 |
61 | University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N-0W8 |
62 | CHUQ | Quebec | Canada | G1R 2J6 | |
63 | Beijing Boren Hospital | Beijing | China | 100071 | |
64 | Peking University Third Hospital | Beijing | China | 100191 | |
65 | Peking Union Medical College Hospital | Beijing | China | 100730 | |
66 | First Hospital of Jilin University | Changchun | China | 130021 | |
67 | Beijing Chaoyang Hospital Capital Medical University | Chaoyang District | China | 100020 | |
68 | Guangdong General Hospital | Guangzhou | China | 510030 | |
69 | Sun Yat-sen University Cancer Center | Guangzhou | China | 510060 | |
70 | The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou City | China | 310006 | |
71 | The First Affiliated Hospital of Medical School of Zhejiang University | Hangzhou, Zhejiang | China | 310006 | |
72 | The First Affiliated Hospital of Harbin Medical University | Harbin | China | 150081 | |
73 | Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University | Nanjing | China | 210029 | |
74 | Ruijin Hospital Shanghai Jiaotong University | Shanghai | China | 200025 | |
75 | Shengjing Hospital Of China Medical University | Shenyang | China | 110004 | |
76 | The First Affiliated Hospital of Soochow University | Suzhu | China | 215006 | |
77 | Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences | Tianjin | China | 300020 | |
78 | Local Institution - 133 | Tianjin | China | 300020 | |
79 | Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China | 430030 | |
80 | Xijing Hospital | Xian | China | 710000 | |
81 | Henan Cancer Hospital | Zhengzhou | China | ||
82 | Fakultni Nemocnice Brno | Brno | Czechia | 625 00 | |
83 | Fakultni Nemocnice Ostrava | Ostrava-Poruba | Czechia | 708 52 | |
84 | Vseobecna Fakultni Nemocnice v Praze | Prague 2 | Czechia | 128 08 | |
85 | Aalborg Universitetshospital | Aalborg | Denmark | 9000 | |
86 | Aarhus University Hospital | Aarhus | Denmark | 8000 | |
87 | Odense University Hospital | Odense | Denmark | DK-5000 | |
88 | Sealand University Hospital | Roskilde | Denmark | 4000 | |
89 | Helsinki University Central Hospital | Helsinki | Finland | 290 | |
90 | Oulu University Hospital | Oulu | Finland | 90220 | |
91 | Turku University Hospital | Turku | Finland | FI-20520 | |
92 | CH Argenteuil Victor Dupouy | Argenteuil | France | 95100 | |
93 | Hopital Henri Mondor | Creteil | France | 94010 | |
94 | Centre Hospitalier Departemental de Vendee | La Roche -Sur-Yon - Cedex 9 | France | 85925 | |
95 | CHRU de Lille France | Lille Cedex | France | 59037 | |
96 | CHU Montpellier- Hopital Lapeyronie | Montpellier Cedex 5 | France | 34295 | |
97 | Local Institution - 455 | Montpellier Cedex 5 | France | 34295 | |
98 | CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage | Nancy Cedex | France | 54511 | |
99 | CHRU Nantes | Nantes | France | 44093 | |
100 | Hopital Saint-Louis | Paris Cedex | France | 75475 | |
101 | Hopital Saint Antoine | Paris | France | 75012 | |
102 | CHU Bordeaux | Pessac | France | 33604 | |
103 | Centre Hospitalier Lyon-Sud | Pierre-Benite CEDEX | France | 69495 | |
104 | CHU La Miletrie | Poitiers Cedex | France | 86021 | |
105 | CHRU Rennes | Rennes | France | 35033 | |
106 | CLCC H BecquerelHematology | Rouen | France | 76038 | |
107 | Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse Cedex 9 | France | 31059 | |
108 | Local Institution - 0978 | Kiel | Schleswig-Holstein | Germany | 24105 |
109 | Universitätsklinikum der RWTH Aachen | Aachen | Germany | 52074 | |
110 | Local Institution - 307 | Erlangen | Germany | 91054 | |
111 | Universitatsklinikum Erlangen | Erlangen | Germany | 91054 | |
112 | Klinikum der Johann Wolfgang Goethe Universitat | Frankfurt am Main | Germany | 60590 | |
113 | Universitaetsklinik Hamburg - Eppendorf | Hamburg | Germany | 20246 | |
114 | Asklepios Klinik St. Georg | Hamburg | Germany | D-20099 | |
115 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
116 | Local Institution - 304 | Munster | Germany | 48149 | |
117 | Universitaetsklinikum Muenster | Munster | Germany | 48149 | |
118 | Local Institution - 303 | Wuerzburg | Germany | 97080 | |
119 | Universitaetsklinikum Wuerzburg | Wuerzburg | Germany | 97080 | |
120 | Alexandra General Hospital of Athens | Athens | Greece | 115 28 | |
121 | Local Institution - 571 | Athens | Greece | 115 28 | |
122 | Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | Greece | 57010 | |
123 | Cork University Hospital | Cork | Ireland | ||
124 | Beaumont Hospital | Dublin 9 | Ireland | D09 V2N0 | |
125 | St James Hospital | Dublin | Ireland | Dublin 8 | |
126 | University Hospital Galway | Galway | Ireland | ST46QG | |
127 | Rambam Medical Center | Haifa | Israel | 35254 | |
128 | Hadassah Medical Center | Jerusalem | Israel | 91120 | |
129 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 64239 | |
130 | A.O.U. di Bologna Policlinico S.Orsola-Malpighi | Bologna | Italy | 40138 | |
131 | Università di Catania- Presidio Ospedaliero Ferrarotto | Catania | Italy | 95124 | |
132 | Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
133 | ASST Grande Ospedale Metropolitano Niguarda, Milano | Milano | Italy | 20162 | |
134 | A.O.U. Maggiore della Carità | Novara | Italy | 28100 | |
135 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
136 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
137 | Azienda Ospedaliera Universitaria Pisana | Pisa | Italy | 56100 | |
138 | Azienda Ospedaliera Bianchi-Melacrino-Morelli | Reggio Calabria | Italy | 89100 | |
139 | Arcispedale Santa Maria Nuova - AUSL Reggio Emilia | Reggio Emilia | Italy | 42122 | |
140 | Azienda Ospedaliera S. Andrea - Università La Sapienza | Roma | Italy | 00189 | |
141 | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo FG | Italy | 71013 | |
142 | Azienda Ospedaliera S Maria di Terni | Terni | Italy | 05100 | |
143 | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine | Udine | Italy | 33100 | |
144 | Aomori Prefectural Central Hospital | Aomori | Japan | 030-8553 | |
145 | National Hospital Organization Kyushu Medical Center | Fukuoka | Japan | 810-8563 | |
146 | Kameda Medical Center | Kamogawa | Japan | 296-8602 | |
147 | University Hospital Kyoto Prefectural University of Medicine | Kyoto-City | Japan | 602-8566 | |
148 | Matsuyama Red Cross Hospital | Matsuyama | Japan | 790-8524 | |
149 | Aichi Cancer Center | Nagoya | Japan | 464-8681 | |
150 | Nagoya City University Hospital | Nagoya | Japan | 467-8602 | |
151 | Okayama Medical Center | Okayama | Japan | 701-1192 | |
152 | Kindai University Hospital | Osaka-Sayama | Japan | 589-8511 | |
153 | Osaka City University Hospital | Osaka | Japan | 545-8585 | |
154 | Sapporo Hokuyu Hospital | Sapporo | Japan | 003-0006 | |
155 | Tohoku University Hospital | Sendai | Japan | 980-8574 | |
156 | Japan Red Cross Medical Center | Shibuya-ku | Japan | 150-8935 | |
157 | NTT Medical Center Tokyo | Shinagawa-ku, Tokyo | Japan | 141-8625 | |
158 | Toyohashi Municipal Hospital | Toyohashi | Japan | 441-8570 | |
159 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 700-721 | |
160 | National Cancer Center | Gyeonggi-do | Korea, Republic of | 410-769 | |
161 | Hwasun Chonnam National University Hospital | Hwasun-gun | Korea, Republic of | 519-809 | |
162 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 120-752 | |
163 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
164 | The Catholic University of Korea Seoul - Saint Mary's Hospital | Seoul | Korea, Republic of | 137-701 | |
165 | Seoul National University Hospital | Seoul | Korea, Republic of | 3080 | |
166 | Asan Medical Center | Seoul | Korea, Republic of | 5505 | |
167 | Vrije Universiteit Medisch Centrum (VUMC) | Amsterdam | Netherlands | 1081 HV | |
168 | HagaZiekenhuis | Den Haag | Netherlands | 2545 CH | |
169 | Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | 3318 AT | |
170 | Haukeland University Hospital | Bergen | Norway | N-5053 | |
171 | Oslo Universitetssykehus HF Ulleval | Oslo | Norway | 0424 | |
172 | Trondheim university hospital | Trondheim | Norway | 7030 | |
173 | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | 15-276 | |
174 | Uniwersytet Jagiellonski Collegium Medicum | Krakow | Poland | 31-501 | |
175 | Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu | Nowy Sacz | Poland | 33-300 | |
176 | Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | Poland | 60-569 | |
177 | Specjalistyczny Szpital im. dra Alfreda Sokolowskiego | Walbrzych | Poland | 58-309 | |
178 | Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie | Warszawa | Poland | 02-781 | |
179 | Uniwersytecki Szpital Kliniczny | Wroclaw | Poland | 50-367 | |
180 | Centro Hospital e Universitario de Coimbra | Coimbra | Portugal | 4200-072 | |
181 | Instituto Portugues de Oncologia de Lisboa, Francisco Gentil | Lisboa | Portugal | 1099-023 | |
182 | Champalimaud Cancer Center | Lisboa | Portugal | 1400-038 | |
183 | Hospital Center of Lisbon North E.P.E - Hospital Pulido Valente | Lisboa | Portugal | 1649-035 | |
184 | Ipo Instituto Portugues De Oncologia Porto | Porto | Portugal | 4200-072 | |
185 | Centro Hospitalar de Sao Joao, EPE | Porto | Portugal | 4200-319 | |
186 | City Clinical Hospital 52 | Moscow | Russian Federation | 123182 | |
187 | State Institution Hematological Research, Centre of Russian Academy of Medical Science | Moscow | Russian Federation | 125167 | |
188 | Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin | Moscow | Russian Federation | 125284 | |
189 | Novosibirsk State Medical University | Novosibirsk | Russian Federation | 630091 | |
190 | Pavlov First Saint Petersburg State Medical University | Saint-Petersburg | Russian Federation | 197022 | |
191 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
192 | Hospital Universitario Vall D hebron - PPDS | Barcelona | Spain | 08035 | |
193 | Hospital Universitari Germans Trias i Pujol | Barcelona | Spain | 08916 | |
194 | Hospital San Pedro de Alcantara | Caceres | Spain | 10005 | |
195 | Hospital Universitario Reina Sofia | Cordoba | Spain | 14001 | |
196 | Hospital de La Princesa | Madrid | Spain | 28006 | |
197 | Local Institution - 0979 | Madrid | Spain | 28027 | |
198 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
199 | Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | 28040 | |
200 | Hospital Universitario Virgen de la Victoria | Malaga | Spain | 29010 | |
201 | Hospital Universitario Virgen de La Arrixaca | Murcia | Spain | 30120 | |
202 | Hospital Universitario Central de Asturias | Oviedo | Spain | 33011 | |
203 | Clinica Universidad de Navarra | Pamplona | Spain | 31008 | |
204 | Universitario de Salamanca - Hospital Clinico | Salamanca | Spain | 37007 | |
205 | Hospital Clinico Universitario de Santiago | Santiago de Compostela | Spain | 15706 | |
206 | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | 46026 | |
207 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
208 | Medicinkliniken | Boras | Sweden | 501 82 | |
209 | Sahlgrenska University Hospital Department of Hematology and Coagulation | Goteborg | Sweden | S-413 45 | |
210 | Helsingborg hospital | Helsingborg | Sweden | 254 37 | |
211 | Local Institution - 270 | Lund | Sweden | 222 41 | |
212 | Lund University Hosptial | Lund | Sweden | 222 41 | |
213 | Kantonsspital Graubunden | Chur | Switzerland | 7000 | |
214 | Kantonsspital St. GallenBereich OnkologieHamatologie | St. Gallen | Switzerland | CH-9007 | |
215 | Chang Gung Medical Foundation, Kaohsiung Memorial Hospital | Niao-Sung Hsiang Kaohsiung County | Taiwan | 83301 | |
216 | China Medical University Hospital | Taichung City | Taiwan | 40447 | |
217 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
218 | National Cheng Kung University Hospital | Tainan, Taiana | Taiwan | 704 | |
219 | National Taiwan University Hospital | Taipei, Zhongzheng Dist. | Taiwan | 10002 | |
220 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
221 | Chang Gung Medical Foundation, Linkou Memorial Hospital | Taoyuan City | Taiwan | 33305 | |
222 | Ankara University Medical Faculty | Ankara | Turkey | 06100 | |
223 | Dokuz Eylul University Medical Faculty | Balçova | Turkey | 35330 | |
224 | Gazi Universitesi | Besevler Ankara | Turkey | 06500 | |
225 | Ege University Medical Faculty | Izmir | Turkey | 35100 | |
226 | Erciyes University Medical Faculty | Kayseri | Turkey | 38039 | |
227 | Ondokuz Mayis University Medical Faculty | Samsun | Turkey | 55139 | |
228 | Belfast City Hospital | Belfast Northern Ireland | United Kingdom | BT9 7AD | |
229 | University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2TH | |
230 | Kent and Canterbury Hospital | Canterbury Kent | United Kingdom | CT1 3NG | |
231 | Victoria Hospital Blackpool | Lancashire Blackpool | United Kingdom | FY3 8NR | |
232 | Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
233 | University College London Hospitals NHS Foundation Trust - University College Hospital | London | United Kingdom | NW1 2BU | |
234 | Guy's and St Thomas' Hospital - London | London | United Kingdom | SE1 9RT | |
235 | Freeman Hospital | Newcastle upon Tyne | United Kingdom | NE7 7DN | |
236 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB | |
237 | Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre | Oxford | United Kingdom | OX3 7LE | |
238 | Queen Alexandra Hospital - Portsmouth | Portsmouth | United Kingdom | PO6 3LY | |
239 | The Royal Marsden NHS Foundation Trust | Sutton | United Kingdom | SM2 5PT | |
240 | Royal Cornwall Hospitals Trust | Truro | United Kingdom | TR1 3LJ | |
241 | New Cross Hospital | Wolverhampton | United Kingdom | WV10 0QP |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CC-220-MM-002
- U1111-1260-2872
- 2020-000431-49