Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04975997




Registration number
NCT04975997
Ethics application status
Date submitted
2/07/2021
Date registered
26/07/2021

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
U1111-1260-2872
Secondary ID [2] 0 0
CC-220-MM-002
Universal Trial Number (UTN)
Trial acronym
EXCALIBER-RRMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab
Treatment: Drugs - Bortezomib
Treatment: Drugs - Iberdomide
Treatment: Drugs - Iberdomide
Treatment: Drugs - Iberdomide

Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 - Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.

Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2 -

Experimental: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3 -

Active comparator: Daratumumab in combination with dexamethasone and bortezomib - Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone


Treatment: Drugs: Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Treatment: Drugs: 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

Treatment: Drugs: 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.

Treatment: Drugs: Iberdomide
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

Treatment: Drugs: Iberdomide
Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle

Treatment: Drugs: Iberdomide
Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Minimal Residual Disease (MRD) negativity rate
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Time to response (TTR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Time to Progression (TTP)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Time to Next Treatment (TTNT)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Progression-free Survival 2 (PFS2)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
Safety
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Recommended iberdomide dose for Stage 2
Timepoint [12] 0 0
Up to approximately 1 year
Secondary outcome [13] 0 0
Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))
Timepoint [13] 0 0
Up to approximately 1 year
Secondary outcome [14] 0 0
Maximum plasma concentration (Cmax)
Timepoint [14] 0 0
Up to approximately 1 year
Secondary outcome [15] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [15] 0 0
Up to approximately 1 year

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/06/2032
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre, Dept Of Oncology - Bedford Park
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 0 0
Perth Blood Institute - West Perth
Recruitment hospital [10] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [11] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [12] 0 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3001 - East Melbourne
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6005 - West Perth
Recruitment postcode(s) [10] 0 0
2050 - Camperdown
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
ACT 2605 - Garran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Austria
State/province [28] 0 0
Graz
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Austria
State/province [31] 0 0
St Polten
Country [32] 0 0
Austria
State/province [32] 0 0
Vienna
Country [33] 0 0
Austria
State/province [33] 0 0
Wien
Country [34] 0 0
Belgium
State/province [34] 0 0
Brugge
Country [35] 0 0
Belgium
State/province [35] 0 0
Bruxelles
Country [36] 0 0
Brazil
State/province [36] 0 0
Parana
Country [37] 0 0
Brazil
State/province [37] 0 0
RIO Grande DO SUL
Country [38] 0 0
Brazil
State/province [38] 0 0
RS
Country [39] 0 0
Brazil
State/province [39] 0 0
SAO Paulo
Country [40] 0 0
Brazil
State/province [40] 0 0
São Paulo
Country [41] 0 0
Brazil
State/province [41] 0 0
Rio de Janeiro
Country [42] 0 0
Brazil
State/province [42] 0 0
Sao Paulo
Country [43] 0 0
Canada
State/province [43] 0 0
Alberta
Country [44] 0 0
Canada
State/province [44] 0 0
British Columbia
Country [45] 0 0
Canada
State/province [45] 0 0
New Brunswick
Country [46] 0 0
Canada
State/province [46] 0 0
Newfoundland and Labrador
Country [47] 0 0
Canada
State/province [47] 0 0
Nova Scotia
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Canada
State/province [49] 0 0
Saskatchewan
Country [50] 0 0
China
State/province [50] 0 0
Hunan
Country [51] 0 0
China
State/province [51] 0 0
Jiangxi
Country [52] 0 0
China
State/province [52] 0 0
Shaanxi
Country [53] 0 0
China
State/province [53] 0 0
Shanghai
Country [54] 0 0
China
State/province [54] 0 0
Shanxi
Country [55] 0 0
China
State/province [55] 0 0
Zhejiang
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Changchun
Country [58] 0 0
China
State/province [58] 0 0
Chaoyang District
Country [59] 0 0
China
State/province [59] 0 0
Guangzhou
Country [60] 0 0
China
State/province [60] 0 0
Hangzhou City
Country [61] 0 0
China
State/province [61] 0 0
Hangzhou, Zhejiang
Country [62] 0 0
China
State/province [62] 0 0
Harbin
Country [63] 0 0
China
State/province [63] 0 0
Nanjing
Country [64] 0 0
China
State/province [64] 0 0
Shenyang
Country [65] 0 0
China
State/province [65] 0 0
Suzhu
Country [66] 0 0
China
State/province [66] 0 0
Tianjin
Country [67] 0 0
China
State/province [67] 0 0
Wuhan
Country [68] 0 0
China
State/province [68] 0 0
Xian
Country [69] 0 0
China
State/province [69] 0 0
Zhengzhou
Country [70] 0 0
Czechia
State/province [70] 0 0
Brno
Country [71] 0 0
Czechia
State/province [71] 0 0
Ostrava-Poruba
Country [72] 0 0
Czechia
State/province [72] 0 0
Prague 2
Country [73] 0 0
Denmark
State/province [73] 0 0
Aalborg
Country [74] 0 0
Denmark
State/province [74] 0 0
Odense
Country [75] 0 0
Denmark
State/province [75] 0 0
Roskilde
Country [76] 0 0
Finland
State/province [76] 0 0
Varsinais-Suomi
Country [77] 0 0
Finland
State/province [77] 0 0
Helsinki
Country [78] 0 0
Finland
State/province [78] 0 0
Oulu
Country [79] 0 0
France
State/province [79] 0 0
Argenteuil
Country [80] 0 0
France
State/province [80] 0 0
La Roche -Sur-Yon - Cedex 9
Country [81] 0 0
France
State/province [81] 0 0
Lille Cedex
Country [82] 0 0
France
State/province [82] 0 0
Nancy Cedex
Country [83] 0 0
France
State/province [83] 0 0
Nantes
Country [84] 0 0
France
State/province [84] 0 0
Paris Cedex
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Pessac
Country [87] 0 0
France
State/province [87] 0 0
Rouen
Country [88] 0 0
France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
Germany
State/province [89] 0 0
Schleswig-Holstein
Country [90] 0 0
Germany
State/province [90] 0 0
Frankfurt am Main
Country [91] 0 0
Germany
State/province [91] 0 0
Hamburg
Country [92] 0 0
Germany
State/province [92] 0 0
Heidelberg
Country [93] 0 0
Germany
State/province [93] 0 0
Lubeck
Country [94] 0 0
Greece
State/province [94] 0 0
Achaea
Country [95] 0 0
Greece
State/province [95] 0 0
Achaia
Country [96] 0 0
Greece
State/province [96] 0 0
Athens
Country [97] 0 0
Greece
State/province [97] 0 0
Thessaloniki
Country [98] 0 0
India
State/province [98] 0 0
Andhra Pradesh
Country [99] 0 0
India
State/province [99] 0 0
Karnataka
Country [100] 0 0
India
State/province [100] 0 0
Kerala
Country [101] 0 0
India
State/province [101] 0 0
Maharashtra
Country [102] 0 0
India
State/province [102] 0 0
West Bengal
Country [103] 0 0
India
State/province [103] 0 0
Pondicherry
Country [104] 0 0
Ireland
State/province [104] 0 0
Cork
Country [105] 0 0
Ireland
State/province [105] 0 0
Dublin 9
Country [106] 0 0
Ireland
State/province [106] 0 0
Galway
Country [107] 0 0
Israel
State/province [107] 0 0
HaZafon
Country [108] 0 0
Israel
State/province [108] 0 0
Haifa
Country [109] 0 0
Israel
State/province [109] 0 0
Jerusalem
Country [110] 0 0
Israel
State/province [110] 0 0
Tel Aviv
Country [111] 0 0
Israel
State/province [111] 0 0
Tel Hashomer
Country [112] 0 0
Italy
State/province [112] 0 0
Lazio
Country [113] 0 0
Italy
State/province [113] 0 0
Bologna
Country [114] 0 0
Italy
State/province [114] 0 0
Catania
Country [115] 0 0
Italy
State/province [115] 0 0
Genova
Country [116] 0 0
Italy
State/province [116] 0 0
Milano
Country [117] 0 0
Italy
State/province [117] 0 0
Novara
Country [118] 0 0
Italy
State/province [118] 0 0
Pavia
Country [119] 0 0
Italy
State/province [119] 0 0
Pisa
Country [120] 0 0
Italy
State/province [120] 0 0
Reggio Calabria
Country [121] 0 0
Italy
State/province [121] 0 0
Reggio Emilia
Country [122] 0 0
Italy
State/province [122] 0 0
Roma
Country [123] 0 0
Italy
State/province [123] 0 0
San Giovanni Rotondo FG
Country [124] 0 0
Italy
State/province [124] 0 0
Terni
Country [125] 0 0
Italy
State/province [125] 0 0
Udine
Country [126] 0 0
Japan
State/province [126] 0 0
Ehime
Country [127] 0 0
Japan
State/province [127] 0 0
Ibaraki
Country [128] 0 0
Japan
State/province [128] 0 0
Tochigi
Country [129] 0 0
Japan
State/province [129] 0 0
Tokyo
Country [130] 0 0
Japan
State/province [130] 0 0
Yamanashi
Country [131] 0 0
Japan
State/province [131] 0 0
Aomori
Country [132] 0 0
Japan
State/province [132] 0 0
Chiba
Country [133] 0 0
Japan
State/province [133] 0 0
Fukuoka
Country [134] 0 0
Japan
State/province [134] 0 0
Kamogawa
Country [135] 0 0
Japan
State/province [135] 0 0
Kyoto-City
Country [136] 0 0
Japan
State/province [136] 0 0
Nagoya
Country [137] 0 0
Japan
State/province [137] 0 0
Okayama
Country [138] 0 0
Japan
State/province [138] 0 0
Osaka-Sayama
Country [139] 0 0
Japan
State/province [139] 0 0
Osaka
Country [140] 0 0
Japan
State/province [140] 0 0
Sapporo
Country [141] 0 0
Japan
State/province [141] 0 0
Sendai
Country [142] 0 0
Japan
State/province [142] 0 0
Shibuya-ku
Country [143] 0 0
Japan
State/province [143] 0 0
Shinagawa-ku, Tokyo
Country [144] 0 0
Japan
State/province [144] 0 0
Toyohashi
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Daegu
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Gyeonggi-do
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Hwasun-gun
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Seoul
Country [149] 0 0
Mexico
State/province [149] 0 0
Distrito Federal
Country [150] 0 0
Mexico
State/province [150] 0 0
Jalisco
Country [151] 0 0
Mexico
State/province [151] 0 0
La Raza
Country [152] 0 0
Mexico
State/province [152] 0 0
Mexico City
Country [153] 0 0
Netherlands
State/province [153] 0 0
Zuid-Holland
Country [154] 0 0
Netherlands
State/province [154] 0 0
Amsterdam
Country [155] 0 0
Netherlands
State/province [155] 0 0
Den Haag
Country [156] 0 0
Norway
State/province [156] 0 0
Bergen
Country [157] 0 0
Norway
State/province [157] 0 0
Oslo
Country [158] 0 0
Norway
State/province [158] 0 0
Trondheim
Country [159] 0 0
Poland
State/province [159] 0 0
Podlaskie
Country [160] 0 0
Poland
State/province [160] 0 0
Krakow
Country [161] 0 0
Poland
State/province [161] 0 0
Nowy Sacz
Country [162] 0 0
Poland
State/province [162] 0 0
Poznan
Country [163] 0 0
Poland
State/province [163] 0 0
Walbrzych
Country [164] 0 0
Poland
State/province [164] 0 0
Warszawa
Country [165] 0 0
Portugal
State/province [165] 0 0
Coimbra
Country [166] 0 0
Portugal
State/province [166] 0 0
Lisboa
Country [167] 0 0
Portugal
State/province [167] 0 0
Porto
Country [168] 0 0
South Africa
State/province [168] 0 0
Gauteng
Country [169] 0 0
South Africa
State/province [169] 0 0
Western Cape
Country [170] 0 0
Spain
State/province [170] 0 0
Navarra
Country [171] 0 0
Spain
State/province [171] 0 0
Barcelona
Country [172] 0 0
Spain
State/province [172] 0 0
Caceres
Country [173] 0 0
Spain
State/province [173] 0 0
Cordoba
Country [174] 0 0
Spain
State/province [174] 0 0
Madrid
Country [175] 0 0
Spain
State/province [175] 0 0
Malaga
Country [176] 0 0
Spain
State/province [176] 0 0
Murcia
Country [177] 0 0
Spain
State/province [177] 0 0
Oviedo
Country [178] 0 0
Spain
State/province [178] 0 0
Salamanca
Country [179] 0 0
Spain
State/province [179] 0 0
Santiago de Compostela
Country [180] 0 0
Spain
State/province [180] 0 0
Valencia
Country [181] 0 0
Spain
State/province [181] 0 0
Zaragoza
Country [182] 0 0
Sweden
State/province [182] 0 0
Boras
Country [183] 0 0
Sweden
State/province [183] 0 0
Helsingborg
Country [184] 0 0
Switzerland
State/province [184] 0 0
Chur
Country [185] 0 0
Switzerland
State/province [185] 0 0
St. Gallen
Country [186] 0 0
Taiwan
State/province [186] 0 0
Niao-Sung Hsiang Kaohsiung County
Country [187] 0 0
Taiwan
State/province [187] 0 0
Taichung City
Country [188] 0 0
Taiwan
State/province [188] 0 0
Taichung
Country [189] 0 0
Taiwan
State/province [189] 0 0
Tainan, Taiana
Country [190] 0 0
Taiwan
State/province [190] 0 0
Taipei, Zhongzheng Dist.
Country [191] 0 0
Taiwan
State/province [191] 0 0
Taipei
Country [192] 0 0
Taiwan
State/province [192] 0 0
Taoyuan City
Country [193] 0 0
Turkey
State/province [193] 0 0
Ankara
Country [194] 0 0
Turkey
State/province [194] 0 0
Istanbul
Country [195] 0 0
Turkey
State/province [195] 0 0
Izmir
Country [196] 0 0
Turkey
State/province [196] 0 0
Kurupelit
Country [197] 0 0
Turkey
State/province [197] 0 0
Gaziantep
Country [198] 0 0
Turkey
State/province [198] 0 0
Kayseri
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Nottinghamshire
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Belfast Northern Ireland
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Birmingham
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Canterbury Kent
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Lancashire Blackpool
Country [204] 0 0
United Kingdom
State/province [204] 0 0
London
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Oxford
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Portsmouth
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Sutton
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04975997