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)

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04975997
Collaborator
(none)
864
241
4
81.9
3.6
0

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).

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
864 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 27, 2022
Anticipated Primary Completion Date :
Jun 11, 2026
Anticipated Study Completion Date :
May 25, 2029

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:
  • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
    Other Names:
  • CC-220
  • 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:
  • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
    Other Names:
  • CC-220
  • 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:
  • DARZALEX FASPRO
  • Drug: Iberdomide
    Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
    Other Names:
  • CC-220
  • 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:
  • DARZALEX FASPRO
  • 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

    1. 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

    1. 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).

    2. 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).

    3. 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.

    4. Time to response (TTR) [Up to approximately 5 years]

      Time from randomization to the first documentation of response (PR or better).

    5. 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.

    6. Time to Progression (TTP) [Up to approximately 5 years]

      The time from randomization to the first documented disease progression.

    7. Time to Next Treatment (TTNT) [Up to approximately 5 years]

      Time from randomization to the start of the next antimyeloma treatment.

    8. 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.

    9. Safety [Up to approximately 5 years]

      Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.

    10. 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.

    11. 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.

    12. Recommended iberdomide dose for Stage 2 [Up to approximately 1 year]

    13. Area under the plasma concentration-time curve from time zero to tau (AUC(TAU)) [Up to approximately 1 year]

    14. Maximum plasma concentration (Cmax) [Up to approximately 1 year]

    15. Time to maximum plasma concentration (Tmax) [Up to approximately 1 year]

    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 multiple myeloma (MM) and measurable disease

    • Received 1 to 2 prior lines of anti-myeloma therapy

    • Must have documented disease progression during or after their last anti-myeloma regimen

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

    Exclusion Criteria:
    • Any condition that confounds the ability to interpret data from the study

    • Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis

    • Known central nervous system involvement with MM

    • Prior therapy with iberdomide

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT04975997
    Other Study ID Numbers:
    • CC-220-MM-002
    • U1111-1260-2872
    • 2020-000431-49
    First Posted:
    Jul 26, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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 19, 2022