Multiple Myeloma Clinical Trial

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

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).

View Full Description

Full 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).

View Eligibility Criteria

Eligibility 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

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 is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

864

Study ID:

NCT04975997

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 261 Locations for this study

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Genesis cancer and Blood Institute (GCBI) - Sarah Cannon
Hot Springs Arkansas, 71913, United States More Info
Stephen Divers, Site 035
Contact
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Eduardo Fernandez-Hernandez, Site 047
Contact
213-208-1272
Samuel Oschin Cancer Center
Los Angeles California, 90048, United States More Info
David Oveisi, Site 044
Contact
310-423-1825
Local Institution - 033
New Haven Connecticut, 06511, United States More Info
Site 033
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Local Institution - 029
Fort Myers Florida, 33901, United States
Advent Health
Orlando Florida, 32804, United States
Local Institution - 028
Saint Petersburg Florida, 33705, United States
BRCR Global
Tamarac Florida, 33321, United States More Info
Andrew Schneider, Site 045
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Local Institution - 034
West Palm Beach Florida, 33401, United States
Emory University
Atlanta Georgia, 30322, United States More Info
Sagar Lonial, Site 018
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404-778-1900
Norton Cancer Institute - St. Matthews Campus
Louisville Kentucky, 40207, United States More Info
Don Stevens, Site 040
Contact
502-899-3366
Christus St Francis Cabrini Hospital
Alexandria Louisiana, 71301, United States More Info
Hafez Halawani, Site 041
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Hematology-Oncology Clinic
Baton Rouge Louisiana, 70809, United States More Info
Michael Castine, Site 027
Contact
225-761-3947
Center For Cancer And Blood Disorders
Bethesda Maryland, 20817, United States More Info
Ralph Boccia, Site 014
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301-571-2016
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Omar Nadeem, Site 010
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617-632-3000
UMASS Memorial Hospital
Worcester Massachusetts, 01655, United States More Info
Muthalagu Ramanathan, Site 009
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508-334-3550
HCA Midwest Health
Kansas City Missouri, 64132, United States More Info
Suman Kambhampati, Site 031
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816-861-4700
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States More Info
Patrick Cobb, Site 046
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406-238-6290
Local Institution - 015
Summit New Jersey, 07901, United States
New York Cancer and Blood Specialists
Bay Shore New York, 11706, United States More Info
Richard Zuniga, Site 042
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631-675-5075
NYU Winthrop Hospital
Mineola New York, 11501, United States
New York University School Of Medicine
New York New York, 10016, United States
New York - Presbyterian/Weill Cornell Medical Center
New York New York, 10021, United States
Duke University Hospital
Durham North Carolina, 27705, United States More Info
Cristina Gasparetto, Site 039
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919-668-1017
TriHealth, Good Samaritan Hospital
Cincinnati Ohio, 45220, United States More Info
Saulius Girnius, Site 038
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617-429-0988
MetroHealth Medical Center - Main Campus
Cleveland Ohio, 44109, United States More Info
Tamila Kindwall-Keller, Site 037
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216-778-7800
Cleveland Clinic - Taussig Cancer Institute
Cleveland Ohio, 44195, United States More Info
Faiz Anwer, Site 008
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520-694-8900
Ohio Health Corporation
Columbus Ohio, 43214, United States More Info
Yvonne Efebera, Site 036
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216-965-8569
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Rebecca Silbermann, Site 043
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503-494-5304
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Tennessee Oncology
Chattanooga Tennessee, 37404, United States More Info
Bertrand Anz III, Site 030
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423-698-1844
Tennessee Oncology Nashville Drug Development Unit
Nashville Tennessee, 37203, United States More Info
Jesus Berdeja, Site 021
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615-329-0570
UT Southwestern Simmons Cancer Center
Dallas Texas, 75390, United States
University Of Wisconsin
Madison Wisconsin, 53705, United States More Info
Timothy Schmidt, Site 025
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Milwaukee Wisconsin, 53226, United States
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Ciudad Autanoma De Buenos Aires Buenos Aires, C1199, Argentina More Info
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Villa Elisa Buenos Aires, B1894, Argentina More Info
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San Carlos de Bariloche RIO Negro, R8400, Argentina
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Cordoba , X5000, Argentina
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Douglas Queensland, 4814, Australia More Info
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Adelaide South Australia, 5000, Australia More Info
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Bedford Park South Australia, 5042, Australia More Info
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Clayton Victoria, 3168, Australia More Info
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Murdoch Western Australia, 6150, Australia More Info
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West Perth Western Australia, 6005, Australia More Info
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Camperdown , 2050, Australia More Info
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Fitzroy , 3065, Australia More Info
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Garran , ACT 2, Australia More Info
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Graz , 73013, Austria More Info
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Innsbruck , 6020, Austria
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Linz , 4010, Austria More Info
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Brugge , 8000, Belgium More Info
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Brussel , 1000, Belgium
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Bruxelles , 1200, Belgium More Info
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Liege , 4000, Belgium More Info
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Curitiba Parana, 80530, Brazil More Info
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Porto Alegre RIO Grande DO SUL, 90610, Brazil More Info
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Jau SAO Paulo, 17210, Brazil More Info
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Barretos São Paulo, 14784, Brazil More Info
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Rio de Janeiro , 22793, Brazil More Info
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St John's Newfoundland and Labrador, A1B3V, Canada More Info
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Hamilton Ontario, L8V5C, Canada
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Nanchang Jiangxi, 33000, China More Info
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Beijing , 10007, China More Info
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Beijing , 10019, China More Info
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Beijing , 10073, China More Info
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Changchun , 13002, China More Info
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Chaoyang District , 10002, China More Info
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Guangzhou , 51003, China More Info
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Guangzhou , 51006, China More Info
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Hangzhou City , 31000, China More Info
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Hangzhou, Zhejiang , 31000, China More Info
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Harbin , 15008, China More Info
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Nanjing , 21002, China More Info
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Shenyang , 11000, China More Info
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Suzhu , 21500, China More Info
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Tianjin , 30002, China More Info
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Wuhan , 43003, China More Info
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Xian , 71000, China More Info
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Brno , 625 0, Czechia More Info
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Ostrava-Poruba , 708 5, Czechia More Info
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Prague 2 , 128 0, Czechia More Info
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Aalborg , 9000, Denmark More Info
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Roskilde , 4000, Denmark More Info
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Turku , FI-20, Finland More Info
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Argenteuil , 95100, France More Info
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La Roche -Sur-Yon - Cedex 9 , 85925, France More Info
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Lille Cedex , 59037, France More Info
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Montpellier Cedex 5 , 34295, France
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Nancy Cedex , 54511, France More Info
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Paris Cedex , 75475, France More Info
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Paris , 75012, France More Info
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Poitiers Cedex , 86021, France
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Rouen , 76038, France More Info
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Toulouse Cedex 9 , 31059, France More Info
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Kiel Schleswig-Holstein, 24105, Germany
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Kiel Schleswig-Holstein, 24105, Germany More Info
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Erlangen , 91054, Germany
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Frankfurt am Main , 60590, Germany More Info
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Hamburg , 20246, Germany More Info
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Hamburg , 22763, Germany More Info
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Heidelberg , 69120, Germany More Info
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Munster , 48149, Germany More Info
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Wuerzburg , 97080, Germany
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Athens , 115 2, Greece More Info
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Thessaloniki , 54007, Greece More Info
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Thessaloniki , 57010, Greece More Info
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Bangalore Karnataka, 56005, India More Info
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Ernakulam Kerala, 68204, India More Info
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Mumbai MH, 40005, India More Info
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Hyderabad Telangana, 50008, India More Info
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Howrah , 71110, India More Info
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Pondicherry , 60500, India More Info
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Cork , T12 D, Ireland More Info
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Dublin 9 , D09 V, Ireland More Info
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Tel Aviv , 64239, Israel More Info
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Tel Hashomer , 52621, Israel More Info
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Roma Lazio, 00193, Italy More Info
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Catania , 95124, Italy More Info
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Reggio Emilia , 42123, Italy More Info
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Roma , 00189, Italy More Info
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San Giovanni Rotondo FG , 71013, Italy More Info
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Terni , 05100, Italy More Info
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Udine , 33100, Italy More Info
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Matsuyama Ehime, 790-8, Japan More Info
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Chuo-shi Yamanashi, 409-3, Japan More Info
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Aomori , 030-8, Japan More Info
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Chiba , 260-8, Japan More Info
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Fukuoka , 810-8, Japan More Info
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Kamogawa , 296-8, Japan More Info
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Kyoto-City , 602-8, Japan More Info
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Nagoya , 464-8, Japan More Info
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Nagoya , 467-8, Japan More Info
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Okayama , 701-1, Japan More Info
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Osaka-Sayama , 589-8, Japan More Info
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Sendai , 980-8, Japan More Info
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Shibuya-ku , 150-8, Japan More Info
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Shinagawa-ku, Tokyo , 141-8, Japan More Info
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Toyohashi , 441-8, Japan More Info
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Daegu , 700-7, Korea, Republic of More Info
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Gyeonggi-do , 410-7, Korea, Republic of More Info
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Hwasun-gun , 519-8, Korea, Republic of More Info
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Seoul , 06351, Korea, Republic of More Info
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Seoul , 06591, Korea, Republic of More Info
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Seoul , 120-7, Korea, Republic of More Info
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Seoul , 3080, Korea, Republic of More Info
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Seoul , 5505, Korea, Republic of More Info
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Mexico City Distrito Federal, 06720, Mexico More Info
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Guadalajara Jalisco, 44600, Mexico More Info
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La Raza , 02990, Mexico More Info
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Mexico City , 14080, Mexico More Info
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Dordrecht Zuid-Holland, 3318 , Netherlands More Info
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Amsterdam , 1081 , Netherlands More Info
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Den Haag , 2545 , Netherlands More Info
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Bergen , N-505, Norway More Info
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Oslo , 0450, Norway More Info
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Trondheim , 7030, Norway More Info
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Bialystok Podlaskie, 15-27, Poland More Info
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Krakow , 30-68, Poland More Info
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Nowy Sacz , 33-30, Poland More Info
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Wroclaw , 50-36, Poland
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Coimbra , 4200-, Portugal More Info
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Moscow , 12318, Russian Federation
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Moscow , 12516, Russian Federation
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Moscow , 12528, Russian Federation
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Novosibirsk , 63009, Russian Federation
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Saint-Petersburg , 19702, Russian Federation
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Barcelona , 08025, Spain More Info
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Barcelona , 08916, Spain More Info
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Caceres , 10005, Spain More Info
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Cordoba , 14001, Spain More Info
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Madrid , 28006, Spain More Info
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Madrid , 28027, Spain
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Madrid , 28027, Spain More Info
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Boras , 50182, Sweden More Info
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Goteborg , S-413, Sweden
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Helsingborg , 25437, Sweden More Info
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Chur , 7000, Switzerland More Info
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Niao-Sung Hsiang Kaohsiung County , 83301, Taiwan More Info
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Taichung City , 40447, Taiwan More Info
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Taichung , 40705, Taiwan More Info
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Yenimahalle Ankara, 6200, Turkey More Info
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Balçova Izmir, 35340, Turkey More Info
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Bornova Izmir, 35100, Turkey More Info
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Ankara , 06100, Turkey More Info
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Gaziantep , 27310, Turkey More Info
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Kayseri , 38140, Turkey More Info
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Nottingham Nottinghamshire, NG5 1, United Kingdom More Info
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Belfast Northern Ireland , BT9 7, United Kingdom More Info
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Canterbury Kent , CT1 3, United Kingdom More Info
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Lancashire Blackpool , FY3 8, United Kingdom More Info
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London , NW1 2, United Kingdom More Info
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London , SE1 9, United Kingdom More Info
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Oxford , OX3 7, United Kingdom More Info
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Portsmouth , PO6 3, United Kingdom More Info
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Sutton , SM2 5, United Kingdom More Info
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Truro , TR1 3, United Kingdom
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Wolverhampton , WV10 , United Kingdom More Info
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How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

864

Study ID:

NCT04975997

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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