COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03682536
Collaborator
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)
350
310
2
109.4
1.1
0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions
Actual Study Start Date :
Jan 2, 2019
Anticipated Primary Completion Date :
Feb 16, 2023
Anticipated Study Completion Date :
Feb 14, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Luspatercept

Drug: Luspatercept
Specified dose on specified days
Other Names:
  • ACE-536
  • Active Comparator: Epoetin alfa

    Drug: Epoetin alfa
    Specified dose on specified days
    Other Names:
  • EPREX®
  • ERYPO®
  • PROCRIT®
  • Outcome Measures

    Primary Outcome Measures

    1. Red blood cell transfusion independence (RBC-TI) for 12 weeks (84 days) with a mean hemoglobin increase ≥ 1.5 g/dL [Week 1 through Week 24]

    Secondary Outcome Measures

    1. RBC-TI for 24 weeks [Week 1 through Week 24]

    2. Mean hemoglobin change over 24 weeks [Week 1 through Week 24]

    3. Hematologic improvement - erythroid response (HI-E) per International Working Group (IWG) [Week 1 through Week 24]

    4. Time to HI-E [Week 1 through Week 24]

    5. RBC-TI for ≥ 12 weeks (84 days) [Week 1 through Week 24]

    6. Duration of RBC-TI ≥ 12 weeks (84 days) [Week 1 through End of Treatment (EOT), up to approximately 60 months]

    7. Time to RBC-TI ≥ 12 weeks (84 days) [Week 1 through Week 24]

    8. Time to first red blood cell (RBC) transfusion [Week 1 through EOT, up to approximately 60 months]

    9. RBC transfusion burden on treatment [Week 1 through Week 24]

    10. RBC-TI for ≥ 56 days (8 weeks) [Week 1 through Week 24]

    11. RBC-TI for a consecutive 24-week period [Week 1 through Week 48]

    12. The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) [Screening through Week 24]

    13. The Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An) questionnaire [Screening through Week 24]

    14. Number of participants with Adverse Events (AEs) [Week 1 through 42 days post last dose]

    15. Pharmacokinetic - area under the concentration-time curve (AUC) [Randomization through 1-year post first dose]

    16. Pharmacokinetic - maximum plasma concentration of drug (Cmax) [Randomization through 1-year post first dose]

    17. Frequency of antidrug antibodies (ADA) [Randomization through 1-year post first dose]

    18. Number of participants progressing to acute myeloid leukemia (AML) [Randomization through up to 60 months]

    19. Percentage of participants progressing to AML [Randomization through up to 60 months]

    20. Time to AML progression [Randomization through up to 60 months]

    21. Overall survival [Randomization through up to 60 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow

    • Endogenous serum erythropoietin (sEPO) level of < 500 U/L

    • Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization

    • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

    Exclusion Criteria:
    • Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia

    • Known history of diagnosis of Acute myeloid leukemia (AML)

    • Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Oncology - Grandview Cancer Center Birmingham Alabama United States 35243
    2 Alta Bates Summit Medical Center Berkeley California United States 94704
    3 Sharp Memorial Hospital San Diego California United States 92123
    4 Innovative Clinical Research Institute Whittier California United States 90603
    5 Innovative Clinical Research Institute Whittier California United States 90603
    6 Yale Cancer Center New Haven Connecticut United States 06520
    7 National Association of Veterans Research and Education Foundations NAVREF Washington District of Columbia United States 20422
    8 Florida Cancer Institute Hudson Florida United States 34667
    9 Florida Cancer Specialists North Region Sarah Cannon Research Saint Petersburg Florida United States 33705
    10 SCRI Florida Cancer Specialists PAN Tallahassee Florida United States 32308
    11 Moffitt Cancer Center Tampa Florida United States 33612
    12 Moffitt Cancer Center Tampa Florida United States 33612
    13 Florida Cancer Specialists West Palm Beach Florida United States 33401
    14 Northwest Georgia Oncology Centers, PC Austell Georgia United States 30106
    15 Norton Healthcare Louisville Kentucky United States 40202
    16 Western Kentucky Hematology and Oncology Group Paducah Kentucky United States 42003
    17 Center For Cancer and Blood Disorders Bethesda Maryland United States 20817
    18 Center For Cancer And Blood Disorders Bethesda Maryland United States 20817
    19 HCA Midwest Health Kansas City Missouri United States 64132
    20 Astera Cancer Care East Brunswick East Brunswick New Jersey United States 08816
    21 Hackensack University Medical Center Hackensack New Jersey United States 07601
    22 East Carolina University Greenville North Carolina United States 27858-4354
    23 Providence Portland Medical Center Portland Oregon United States 97213
    24 Oregon Health & Science University Portland Oregon United States 97239
    25 Univ of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    26 Carolina Blood and Cancer Care Rock Hill South Carolina United States 29732
    27 Tennessee Oncology Nashville Tennessee United States 37203
    28 Baylor University Medical Center Dallas Texas United States 75246
    29 UT Southwestern Simmons Cancer Center Dallas Texas United States 75390
    30 University of Texas- MD Anderson Houston Texas United States 77030
    31 University of Texas- MD Anderson Houston Texas United States 77030
    32 Utah Cancer Specialists - South Salt Lake Salt Lake City Utah United States 84106
    33 University of Virginia Health System Charlottesville Virginia United States 22903
    34 Peninsula Cancer Institute Chesapeake Virginia United States 23320
    35 Providence Regional Cancer Partnership Everett Washington United States 98201
    36 Border Medical Oncology - Albury Wodonga Regional Cancer Centre Albury New South Wales Australia 2640
    37 Blacktown Hospital Blacktown New South Wales Australia 2148
    38 Local Institution - 213 Blacktown New South Wales Australia 2148
    39 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    40 Local Institution - 200 Concord New South Wales Australia 2139
    41 Local Institution - 215 Kogarah New South Wales Australia 2217
    42 St George Hospital Kogarah New South Wales Australia 2217
    43 Shoalhaven Cancer Care Centre Nowra New South Wales Australia 2541
    44 Local Institution - 210 Waratah New South Wales Australia 2298
    45 Newcastle Calvary Mater Hospital Waratah New South Wales Australia 2298
    46 Wollongong Hospital Wollongong New South Wales Australia 2500
    47 Icon Cancer Foundation Auchenflower Queensland Australia 4066
    48 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    49 Local Institution - 204 Clayton Victoria Australia 3168
    50 Monash Medical Centre Clayton Victoria Australia 3168
    51 Cabrini Hospital Malvern Victoria Australia 3144
    52 Local Institution - 203 Malvern Victoria Australia 3144
    53 The Alfred Hospital Melbourne Victoria Australia 3004
    54 Perth Blood Institute West Perth Western Australia Australia 6005
    55 Local Institution - 212 Randwick Australia 2031
    56 The Prince of Wales Hospital Randwick Australia 2031
    57 Elisabethinen Hospital Linz Linz Austria 4020
    58 Medizinische Universitat Wien Vienna Austria 1090
    59 ZNA Middelheim Antwerpen Belgium 2020
    60 Algemeen Ziekenhuis Klina Brasschaat Belgium 2930
    61 Local Institution - 471 Brasschaat Belgium 2930
    62 Cliniques Universitaires St-Luc Brussels Belgium 1200
    63 Grand Hopital de Charleroi Charleroi Belgium 6000
    64 AZ Groeninge Kortrijk Belgium 8500
    65 UZ Gasthuisberg Leuven Belgium 3000
    66 H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat Roeselare Belgium 8800
    67 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    68 University of Alberta Edmonton Alberta Canada T6G 2B7
    69 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    70 Local Institution - 142 Hamilton Ontario Canada L8V 5C2
    71 Ottawa General Hospital Ottawa Ontario Canada K1H 8L6
    72 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    73 Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal Montreal Quebec Canada H1T 2M4
    74 Sir Mortimer B. Davis - Jewish Genl Montreal Quebec Canada H3T 1E2
    75 Saskatoon Cancer Center Saskatoon Saskatchewan Canada S7N 4H4
    76 Centre Hospitalier Universitaire de Sherbrooke CHUS Sherbrooke Canada J1H 5N4
    77 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    78 Local Institution - 560 Hradec Kralove Czechia 500 05
    79 Fakultni Nemocnice Ostrava Ostrava-Poruba Czechia 708 52
    80 Local Institution - 564 Ostrava-Poruba Czechia 708 52
    81 Fakultni nemocnice Kralovske Vinohrady Prague 10 Czechia 100 34
    82 Local Institution - 562 Praha 2 Czechia 128 08
    83 Vseobecna Fakultni Nemocnice v Praze Praha 2 Czechia 128 08
    84 Ustav hematologie a krevni transfuze Praha Czechia 128 20
    85 CHU Angers Angers France 49000
    86 Local Institution - 317 Angers France 49000
    87 Centre Hospitalier de la cote basque Bayonne France 64109
    88 CHU de Caen Caen Cedex 9 France 14033
    89 Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon La Tronche France 38700
    90 Centre Hospitalier Le Mans Le Mans France 72037
    91 CHRU de Lille France Lille France 59037
    92 Local Institution - 309 Lille France 59037
    93 CHU Limoges Limoges Cedex France 87042
    94 Hotel Dieu CHU Nantes Nantes Cedex 01 France 44093
    95 CHU Nice Hopital de L'Archet 2 Nice Cedex 3 France 06200
    96 Local Institution - 301 Nice Cedex 3 France 06200
    97 Assistance Publique - Hopitaux de Paris - Hopitaux Saint-Louis Paris France 75010
    98 Local Institution - 302 Paris France 75010
    99 Cochin, Hôpital Paris France 75014
    100 CHU Bordeaux Pessac France 33604
    101 Local Institution - 308 Pessac France 33604
    102 Centre Hospitalier Lyon Sud Pierre Bénite France 69495
    103 CHU de Poitiers Poitiers France 86021
    104 Local Institution - 316 Poitiers France 86021
    105 Institut de Cancérologie Strasbourg Europe Strasbourg France 67033
    106 CHU Purpan Toulouse France 31059
    107 CHRU Hopital BretonneauOnco-hematologie Tours cedex France 37044
    108 CHU de Nancy-Hopital Brabois Adulte Vandoeuvre les Nancy France 54511
    109 Stauferklinikum Schwab. Gmund Baden-Warttemberg Germany 73557
    110 Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim Berlin Germany 14195
    111 Local Institution - 426 Dresden Germany 01307
    112 Universitaetsklinikum Carl Gustav Carus Dresden Germany 01307
    113 St. Johannes Krankenhaus Duisburg Duisburg Germany 47166
    114 Local Institution - 420 Dusseldorf Germany 40479
    115 Marien Hospital Dusseldorf Germany 40479
    116 OncoResearch Lerchenfeld GmbH Hamburg Germany 22081
    117 Universitatsklinikum Schleswig-Holstein Keil Germany 24105
    118 Praxis fuer Haematologie und Onkologie Koblenz Koblenz Germany 56068
    119 Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hamatologie u. Onkologie Köln Germany 50677
    120 Local Institution - 430 Leipzig Germany 04103
    121 Universitatsklinikum Leipzig Leipzig Germany 04103
    122 Universitaetsklinikum Mannheim Mannheim Germany 68167
    123 Klinikum rechts der Isar der Technischen Universitaet Muenchen Munchen Germany 81675
    124 Local Institution - 421 Munchen Germany 81675
    125 University Hospital of Ulm Ulm Germany 89081
    126 Klinkum der Stadt Villingen-Schwenningen GmbH Villingen-Schwenningen Germany 78052
    127 Rems-Murr-Kliniken Winnenden Germany 71364
    128 Hamatologisch-onkologische Praxis Würzburg Germany 97070
    129 Local Institution - 396 Alexandroupolis Greece 08100
    130 University Hospital of Alexandroupolis Alexandroupolis Greece 08100
    131 Evangelismos General Hospital of Athens Athens Greece 10676
    132 Laiko General Hospital of Athens Athens Greece 11 527
    133 Laiko General Hospital of Athens Athens Greece 115 27
    134 Local Institution - 391 Athens Greece 115 27
    135 Attikon university General Hospital Athens Greece 12464
    136 Local Institution - 392 Athens Greece 12464
    137 General Hospital of Athens - George Gennimatas Athina Greece 115 27
    138 Local Institution - 395 Athina Greece 115 27
    139 University General Hospital of Heraklion Heraklion Greece 711 10
    140 Local Institution - 398 Patras Greece 26500
    141 University of Patras Patras Greece 26500
    142 University General Hospital of Patras Rio Patras Greece 26500
    143 AHEPA University General Hospital of Thessaloniki Thessaloniki Greece 546 36
    144 Georgios Papanikolaou General Hospital of Thessaloniki Thessaloniki Greece 57010
    145 Semmelweis Egyetem Budapest Hungary 1083
    146 Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet Budapest Hungary 1096
    147 Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum Debrecen Hungary 4032
    148 Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar Hungary 7400
    149 Local Institution - 536 Nyiregyhaza Hungary 4400
    150 Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház Nyiregyhaza Hungary 4400
    151 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged Hungary 6720
    152 Carmel Medical Center Haifa Israel 34362
    153 Shaare Zedek Medical Center Jerusalem Israel 91031
    154 Hadassah Medical Center Jerusalem Israel 91120
    155 Meir Medical Center Kfar-Saba Israel 44281
    156 Galilee Medical Center Nahariya Israel 22100
    157 Local Institution - 382 Tel Aviv Israel 64239
    158 Tel Aviv Sourasky Medical Center Department of Hematology Tel Aviv Israel 64239
    159 Shamir Medical Center - Assaf Harofeh Zerifin Israel 70300
    160 Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M Bologna Italy 40138
    161 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50134
    162 Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.) Meldola Italy 47014
    163 A.O. Ospedale Ca Granda - Niguarda Milano Italy 20162
    164 Local Institution - 321 Milano Italy 20162
    165 Azienda Ospedaliero - Universitaria San Luigi Gonzaga Orbassano Italy 10043
    166 Hospital of Di Padova Padova Italy 35128
    167 Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Di Calabria Italy 89124
    168 Local Institution - 326 Reggio Di Calabria Italy 89124
    169 Fondazione PTV Policlinico Tor Vergata Roma Italy 00133
    170 Local Institution - 328 Roma Italy 00133
    171 Azienda Ospedaliera Sant Andrea Roma Italy 00189
    172 La Sapienza, University of Rome Rome Italy 00161
    173 Istituto Clinico Humanitas Rozzano Italy 20089
    174 Local Institution - 323 Rozzano Italy 20089
    175 Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine Udine Italy 33100
    176 Hyogo Prefectural Amagasaki General Medical Center Amagasaki-Shi Japan 660-0892
    177 Fujisawa City Hospital Fujisawa-Shi Japan 251-0052
    178 National Hospital Organization Kyushu Medical Center Fukuoka Japan 810-8563
    179 Hitachi General Hospital Hitachi, Ibaraki Japan 317-0077
    180 Local Institution - 237 Hitachi, Ibaraki Japan 317-0077
    181 Kameda General Hospital Kamogawa Japan 296-8602
    182 JCHO Kyushu Hospital Kitakyushu-Shi Japan 806-0034
    183 Matsuyama Red Cross Hospital Matsuyama Japan 790-8524
    184 Nagaoka Red Cross Hospital Nagaoka-Shi Japan 940-2108
    185 The Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki Japan 852-8511
    186 National Hospital Organization - Nagoya Medical Center Nagoya-shi Japan 460-0001
    187 Ogaki Municipal Hospital Ogaki Japan 503-8502
    188 Okayama City General Medical Center Okayama Japan 700-8557
    189 Kindai University Hospital Osaka-Sayama Japan 589-8511
    190 Osaka City University Hospital Osaka Japan 545-8586
    191 Kitasato University Hospital Sagamihara Japan 252-0375
    192 Aiiku Hospital Sapporo-shi Japan 064-0804
    193 Tohoku University Hospital Sendai Japan 980-8574
    194 Japan Red Cross Medical Center Shibuya-ku Japan 150-8935
    195 Dokkyo Medical University Hospital Shimotsuga-gun Japan 321-0293
    196 NTT Medical Center Tokyo Shinagawa-ku, Tokyo Japan 141-8625
    197 Local Institution - 251 Busan Korea, Republic of 49241
    198 Pusan National University Hospital Busan Korea, Republic of 49241
    199 Kyungpook National University Hospital Daegu Korea, Republic of 700-721
    200 Chonnam National University Hwasun Hospital Hwasun-Gun Korea, Republic of 58128
    201 Local Institution - 253 Seongnam-si Korea, Republic of 13620
    202 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    203 Local Institution - 256 Seoul Korea, Republic of 06591
    204 The Catholic University of Korea Seoul - Saint Mary's Hospital Seoul Korea, Republic of 06591
    205 Samsung Medical Center Seoul Korea, Republic of 135-710
    206 Seoul National University Hospital Seoul Korea, Republic of 3080
    207 Asan Medical Center Seoul Korea, Republic of 5505
    208 Local Institution - 254 Seoul Korea, Republic of 5505
    209 Hospital of Lithuanian University Health and Sciences Kaunas Lithuania LT-50009
    210 Local Institution - 541 Vilnius Lithuania LT-08661
    211 Vilnius University Hospital Santariskiu Klinikos Vilnius Lithuania LT-08661
    212 VU University Medical Center Amsterdam Netherlands 1081 HV
    213 HagaZiekenhuis Den Haag Netherlands 2545 CH
    214 Radboudumc Nijmegen Netherlands 6525 GA
    215 Erasmus Universitair Medisch Centrum Rotterdam Netherlands 3015 CE
    216 Zuyderland Medisch Centrum Sittard-Geleen Netherlands 6162 BG
    217 Local Institution - 570 Lodz Lódzkie Poland 93-513
    218 Local Institution - 575 Gdansk Poland 80-952
    219 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    220 Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Lodz Poland 93-513
    221 Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku Lubin Poland 20-081
    222 Local Institution - 576 Poznan Poland 60-569
    223 Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan Poland 60-569
    224 Kliniczny Szpital Wojewodzki nr 1 im. Fryderyka Chopina w Rzeszowie Rzwszow Poland 35-055
    225 Wojewodzki Szpital Specjalistyczny im Korczaka w Supsku Slupsk Poland 76-200
    226 Local Institution - 578 Walbrzych Poland 58-309
    227 Specjalistyczny Szpital im. dra Alfreda Sokolowskiego Walbrzych Poland 58-309
    228 Wojskowy Instytut Medyczny Warsaw Poland 04-141
    229 Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu Wroclaw Poland 50-367
    230 Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych Wroclaw Poland 50-556
    231 Local Institution - 571 Wroclaw Poland 50-556
    232 Hospital José Joaquim Fernandes Beja Portugal 7801-849
    233 Local Institution - 373 Beja Portugal 7801-849
    234 Hospital de Braga Braga Portugal 4710-243
    235 Instituto Portugues de Oncologia de Lisboa, Francisco Gentil Lisboa Portugal 1099-023
    236 Ipo Instituto Portugues De Oncologia Porto Porto Portugal 4200-072
    237 Centro Hospitalar de Setubal EPE Setubal Portugal 2910-446
    238 Kaluga Regional Hospital Kaluga Russian Federation 248007
    239 Kaluga Regional Hospital Kaluga Russian Federation 248007
    240 Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec Kirov Russian Federation 610027
    241 Federal State Institute Kirov Research Inst. of Hematology and Blood Transfusion of Rosmedtec Kirov Russian Federation 610027
    242 Krasnoyarsk Regional Clinical Hospital Krasnoyarsk Russian Federation 660022
    243 Krasnoyarsk Regional Clinical Hospital Krasnoyarsk Russian Federation 660022
    244 Moscow Clinical Scientific Center Moscow Russian Federation 111123
    245 Moscow Clinical Scientific Center Moscow Russian Federation 111123
    246 City Clinical Hospital 52 Moscow Russian Federation 123182
    247 Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin Moscow Russian Federation 125284
    248 Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin Moscow Russian Federation 125284
    249 City Clinical Hospital 40 Moscow Russian Federation 129301
    250 Saratov State Medical University Saratov Russian Federation 410012
    251 Saratov State Medical University Saratov Russian Federation 410012
    252 Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov St Petersburg Russian Federation 197341
    253 Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov St Petersburg Russian Federation 197341
    254 First Pavlov State Medical University of St. Petersburg St. Petersburg Russian Federation 197022
    255 First Pavlov State Medical University of St. Petersburg St. Petersburg Russian Federation 197022
    256 Tula Regional Oncology Center Tula Russian Federation 300053
    257 Tula Regional Oncology Center Tula Russian Federation 300053
    258 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    259 Instituto Catalan de Oncologia-Hospital Duran i Reynals Barcelona Spain 08908
    260 Hospital Virgenes de las Nieves Granada Spain 18014
    261 Hospital General Universitario Gregorio Maranon Madrid Spain 28007
    262 Hospital Universitario 12 de Octubre Madrid Spain 28041
    263 Hospital Universitario Virgen De La Victoria Malaga Spain 29010
    264 Hospital General Universitario Morales Meseguer Murcia Spain 30008
    265 C. H. de Orense Ourense Spain 32005
    266 Hospital Universitario Central de Asturias Oviedo Spain 33011
    267 Hospital Son Espases Palma de Mallorca Spain 7120
    268 Local Institution - 362 Palma de Mallorca Spain 7120
    269 Hospital Universitario de Salamanca Salamanca Spain 37007
    270 Hospital Universitario Virgen del Rocio Seville Spain 41013
    271 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    272 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026
    273 Sahlgrenska Universitetssjukhuset Goteborg Sweden SE-413 45
    274 Skanes Universitetssjukhus Lund Lund Sweden SE-221 85
    275 Karolinska Universitetssjukhuset - Huddinge Stockholm Sweden SE-141 86
    276 Inselspital Bern Bern Switzerland 3010
    277 Local Institution - 450 Bern Switzerland 3010
    278 Luzerner Kantonsspital Luzern 16 Switzerland 6000
    279 Kantonsspital Winterthur Winterthur Switzerland 8400
    280 Local Institution - 451 Winterthur Switzerland 8400
    281 Changhua Christian Hospital Changhua City, Changhua Taiwan 500
    282 Local Institution - 220 Changhua City, Changhua Taiwan 500
    283 Kaohsiung Chang Gung Memorial Hospital Niaosong District Kaohsiung City Taiwan 83301
    284 China Medical University Hospital Taichung City Taiwan 40447
    285 Local Institution - 223 Taichung City Taiwan 40447
    286 Taichung Veterans General Hospital Taichung Taiwan 40705
    287 Local Institution - 221 Taipei, Zhongzheng Dist. Taiwan 10002
    288 National Taiwan University Hospital Taipei, Zhongzheng Dist. Taiwan 10002
    289 Ankara University Medical Faculty Ankara Turkey 06100
    290 Celal Bayar University Medical Faculty Manisa Turkey 45030
    291 Karadeniz Technical University Medical Faculty Trabzon Turkey 61080
    292 Cherkassy Regional Oncology Center Cherkassy Ukraine 18009
    293 Cherkassy Regional Oncology Center Cherkassy Ukraine 18009
    294 Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center Dnipro Ukraine 49102
    295 Dnipropetrovsk City Multidisciplinary Clinical Hospital No 4, Hematological Center Dnipro Ukraine 49102
    296 State Institution National Research Centre for Radiation Medicine of NAMS of Ukraine Kyiv Ukraine 3115
    297 Institute of Blood Pathology and Transfusion Medicine of the UAMS Lvov Ukraine 79044
    298 Institute of Blood Pathology and Transfusion Medicine of the UAMS Lvov Ukraine 79044
    299 Mykolaiv Regional Clinical Hospital Mykolaiv Ukraine 54058
    300 Mykolaiv Regional Clinical Hospital Mykolaiv Ukraine 54058
    301 CI of TRC Ternopil University Hospital Ternopil Ukraine 46002
    302 CI of TRC Ternopil University Hospital Ternopil Ukraine 46002
    303 Aberdeen Royal Infirmary Aberdeen United Kingdom AB25 2ZN
    304 Royal Bournemouth Hospital Bournemouth United Kingdom BH7 7DW
    305 University of Oxford Headington, Oxford United Kingdom OX3 7LE
    306 Lincoln County Hospital Lincoln United Kingdom LN2 5QY
    307 Local Institution - 407 Lincoln United Kingdom LN2 5QY
    308 Kings College Hospital London United Kingdom SE5 9RS
    309 Hammersmith Hospital London United Kingdom W12 0HS
    310 Christie Hospital NHS Trust Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Celgene
    • Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT03682536
    Other Study ID Numbers:
    • ACE-536-MDS-002
    • U1111-1218-1810
    • 2017-003190-34
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Celgene
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2022