A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

July 1, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000JHGQ
        • Sanatorio Allende
    • B
      • Pilar, B, Argentina, B1629AHJ
        • Hospital Universitario Austral
    • Buenos Aires F.D.
      • Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, C1430EFA
        • "Centro de Educación Médica e Investigaciones Clínicas ""Norberto Quirno"""
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Clayton, Victoria, Australia, 3800
        • Monash Health
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen
      • Sankt Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1140
        • Hanusch-Krankenhaus
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie
  • Belgium
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Campus Kennedylaan
    • WHT
      • Charleroi, WHT, Belgium, 6060
        • Grand Hôpital de Charleroi - Les Viviers
  • Brazil
      • Barretos, Brazil, 14784-400
        • Hospital de Câncer de Barretos - Fundação Pio XII
      • Porto Alegre, Brazil, 90880-480
        • Hospital Mae de Deus
      • Rio de Janeiro, Brazil, 21941-913
        • Instituto COI de Pesquisa, Educação e Gestão
      • Salvador, Brazil, 40110-150
        • Hospital Sao Rafael
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brazil, 24020-096
        • CHN - Complexo Hospitalar de Niterói
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional de Cancer
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
      • São Paulo, São Paulo, Brazil, 08270-070
        • Hospital Santa Marcelina
      • São Paulo, São Paulo, Brazil, 05403-000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • São Paulo, São Paulo, Brazil, 04537-080
        • Clinica Medica Sao Germano
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0208
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Québec, Quebec, Canada
        • CHUQ - The Hôtel-Dieu de Québec
  • Chile
      • Santiago, Chile, 7500691
        • Fundacion Arturo Lopez Perez
      • Temuco, Chile, 4800827
        • Local Institution - 0258
      • Vitacura, Chile, 7650567
        • Clinica Alemana - Vitacura
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100020
        • Beijing Chaoyang Hospital, Capital Medical University
      • Changsha, China, 400011
        • The second Xiangya Hospital of Central South University
      • Fuzhou, China, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 511363
        • Sun Yat-sen University Cancer Center
      • Jinan, China, 250021
        • Shandong Provincial Hospital
      • Nanjing, China, 210029
        • Jiangsu Province Hospital
      • Qingdao, China, 266071
        • Qingdao Municipal Hospital
      • Shanghai, China, 200025
        • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
      • Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Wenzhou, China, 325000
        • Wenzhou Medical University - The First Affiliated Hospital
      • Wuhan, China, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • AH
      • Hefei, AH, China, 230001
        • Anhui Provincial Hospital
    • BJ
      • Beijing, BJ, China, 100038
        • Local Institution - 0326
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • The Fifth Medical Center of People's Liberation Army General Hospital
    • CQ
      • Chongqing, CQ, China, 400030
        • Local Institution - 0321
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • GD
      • Guangzhou, GD, China, 510515
        • Nanfang Hospital of Southern Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Shenzhen, Guangdong, China, 518028
        • Shenzhen Second People's Hospital
    • HN
      • Changsha, HN, China, 410013
        • The Third Xiangya Hospital of Central South University
      • Changsha, HN, China, 410013
        • Xiangya Hospital of Central South University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • JL
      • Changchun, JL, China, 130021
        • The First Hospital of Jilin University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital - The Comprehensive Cancer Center
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330200
        • The First Affiliated Hospital of Nanchang University - Donghu District
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Local Institution - 0094
    • SD
      • Jinan, SD, China, 250012
        • Qilu Hospital of Shandong University
    • SH
      • Shanghai, SH, China, 200434
        • Shanghai Fourth People's Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710032
        • The First Affiliated Hospital of the Air Force Medical University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • ZJ
      • Hangzhou, ZJ, China, 310003
        • The First Affiliated Hospital - Zhejiang University School of Medicine
      • Ningbo, ZJ, China, 315010
        • The First Affiliated Hospital of Ningbo University
  • Colombia
      • Bogotá, Colombia, 110111
        • Instituto Nacional de Cancerología - Bogota
      • Bogotá, Colombia, 110131
        • Fundacion Centro de Tratamiento e Investigacion sobre Cancer Luis Carlos Sarmiento Angulo - CTIC
      • Floridablanca, Colombia, 681004
        • Fundacion Oftalmologica de Santander - FOSCAL
      • Medellín, Colombia, 050034
        • Hospital Pablo Tobon Uribe
      • Valledupar, Colombia, 200001
        • Sociedad de Oncologia y Hematologia del Cesar S.A.S
    • COR
      • Montería, COR, Colombia, 230002
        • Oncomedica S.A.
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0036
      • Olomouc, Czechia, 779 00
        • Fakultni Nemocnice Olomouc
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice
  • Denmark
      • Odense, Denmark, 5000
        • Local Institution - 0028
  • Finland
      • Helsinki, Finland, 00290
        • Helsingin Yliopistollinen Sairaala (HUS) - Syopakeskus (Comprehensive Cancer Center)
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
  • France
      • Amiens, France, 80000
        • CHU Hopital Sud
      • Caen, France, 14033
        • Institut d'Hématologie de Basse-Normandie (IHBN)
      • Créteil, France, 94000
        • CHU Hôpital Henri Mondor
      • La Roche-sur-Yon, France, 85000
        • Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
      • Limoges, France, 87042
        • CHU Limoges - Hopital Dupuytren
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
      • Paris, France, 75012
        • Hopital Saint-Antoine
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Hamburg, Germany, 20246
        • Local Institution - 0297
      • Hamm, Germany, 59073
        • St. Barbara-Klinik Hamm-Heessen GmbH
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitätsklinikum Ulm
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Klinikum Augsburg
      • Bayreuth, Bavaria, Germany, 95445
        • Klinikum Bayreuth GmbH
      • Erlangen, Bavaria, Germany, 91054
        • Universitaetsklinikum Erlangen - Medizinische Klinik 5
      • Munich, Bavaria, Germany, 81377
        • LMU Klinikum der Universitaet Muenchen - Campus Grosshadern - Transplantation
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03048
        • Carl-Thiem-Klinikum Cottbus GmbH
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763
        • Asklepios Klinik Altona
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Klinikum Chemnitz gGmbH
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12203
        • Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • Greece
      • Athens, Greece, 115 28
        • Alexandra General Hospital of Athens
      • Larissa, Greece, 411 10
        • Local Institution - 0290
      • Thessaloniki, Greece, 546 39
        • Theageneio Cancer Hospital of Thessaloniki
    • B
      • Thessaloniki, B, Greece, 570 10
        • "General Hospital of Thessaloniki ""G. Papanikolaou"""
    • G
      • Rio, G, Greece, 265 04
        • University of Patras - Rio Regional University Hospital
    • I
      • Athens, I, Greece, 106 76
        • Evangelismos General Hospital of Athens
  • Hong Kong
    • HK
      • Hong Kong, HK, Hong Kong, 999077
        • Queen Mary Hospital
  • Hungary
    • HB
      • Debrecen, HB, Hungary, 4032
        • Debreceni Egyetem Klinikai Központ III. sz. Belgyógyászati Klinika
  • India
    • Chandigarh
      • Chandigarh, Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education & Research (PGIMER)
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Local Institution - 0110
    • Kerala
      • Kochi, Kerala, India, 68202
        • Aster Medcity
    • Maharashtra
      • Kolhāpur, Maharashtra, India, 416005
        • Dr. Bafnas Star Superspecaility Clinic and Hospital
      • Nagpur, Maharashtra, India, 440030
        • Alexis Multispeciality Hospital
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
      • Pune, Maharashtra, India, 411 004
        • Deenanath Mangeshkar Hospital & Research Center
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Sparsh Hospitals & Critical Care
    • West Bengal
      • Kolkata, West Bengal, India, 700160
        • Tata Medical Center
  • Israel
      • Ashdod, Israel, 7747629
        • Assuta Medical Center
      • Beer Ya'Aqov, Israel, 70300
        • Assaf Harofeh Medical Center
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center - Davidoff Center
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Naples, Italy, 80131
        • "Azienda Ospedaliera Universitaria ""Federico II"""
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Rome, Italy, 00161
        • Policlinico Umberto I
    • CT
      • Catania, CT, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
    • FI
      • Florence, FI, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
    • GE
      • Genova, GE, Italy, 16132
        • Ospedale Policlinico San Martino
    • MI
      • Milan, MI, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • PI
      • Pisa, PI, Italy, 56127
        • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
    • TO
      • Torino, TO, Italy, 10126
        • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
  • Japan
      • Chiba, Japan, 260-8677
        • Local Institution - 0141
      • Gifu, Japan, 500-8513
        • Local Institution - 0118
      • Higashiibaraki-Gun, Japan, 311-3193
        • Local Institution - 0133
      • Hiroshima, Japan, 730-8619
        • Local Institution - 0112
      • Isehara-shi, Japan, 259-1193
        • Local Institution - 0199
      • Itabashi-Ku, Japan, 173-8610
        • Local Institution - 0330
      • Kagoshima, Japan, 890-8520
        • Local Institution - 0111
      • Kanazawa, Japan, 920-8641
        • Local Institution - 0144
      • Kobe, Japan, 650-0047
        • Local Institution - 0134
      • Kōtoku, Japan, 135-8550
        • Local Institution - 0122
      • Maebashi, Japan, 371-8511
        • Local Institution - 0121
      • Minatoku, Japan, 105-8471
        • Local Institution - 0150
      • Nagasaki, Japan, 852-8511
        • Local Institution - 0104
      • Nagoya, Japan, 467-8602
        • Nagoya City University Hospital
      • Nerima-Ku, Japan, 179-0072
        • Local Institution - 0329
      • Saitama-Shi, Japan, 330-0834
        • Local Institution - 0148
      • Sakaishi, Japan, 590-0197
        • Local Institution - 0268
      • Sapporo, Japan, 003-0006
        • Local Institution - 0105
      • Sendai, Japan, 983-8520
        • Local Institution - 0132
      • Shibuya-ku, Japan, 150-8935
        • Japanese Red Cross Medical Center
    • Gunma
      • Shibukawa-shi, Gunma, Japan, 3770280
        • Local Institution - 0106
    • Kanagawa
      • Kamakura-Shi, Kanagawa, Japan, 2478533
        • Local Institution - 0197
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-8556
        • Local Institution - 0198
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution - 0130
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • "Universidad Autonoma de Nuevo Leon - Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"""
    • State of Mexico
      • Toluca, State of Mexico, Mexico, 50090
        • Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca
  • Netherlands
      • Dordrecht, Netherlands, 3300 AK
        • Albert Schweitzer Hospital - Locatie Dordwijk
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • VU University Medical Center
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Local Institution - 0327
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice, Poland, 44-102
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
      • Katowice, Poland, 40-519
        • Pratia Onkologia Katowice
      • Lublin, Poland, 20-134
        • Office of Dr n. Med. Wojciech Legiec
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-510
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  • Portugal
      • Braga, Portugal, 4710-243
        • Unidade Local de Saude Braga
      • Coimbra, Portugal, 3000-075
        • Unidade Local de Saúde de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Porto, Portugal, 4200-072
        • Instituto Português Oncologia do Porto Francisco Gentil, EPE
  • Romania
      • Cluj-Napoca, Romania, 400015
        • "Institutul Oncologic ""Prof. Dr. Ion Chiricuţă"" Cluj Napoca"
    • B
      • Bucharest, B, Romania, 022328
        • Institutul Clinic Fundeni
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
    • IS
      • Iași, IS, Romania, 700483
        • Institutul Regional de Oncologie Iasi
    • Jud. Cluj
      • Cluj-Napoca, Jud. Cluj, Romania, 400015
        • "Institutul Oncologic ""Prof. Dr. Ion Chiricuţă"" Cluj Napoca"
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital (S) Pte Ltd
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Goyang-si, South Korea, 410-769
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Yonsei University Health System, Severance Hospital
      • Ulsan, South Korea, 44033
        • Ulsan University Hospital (UUH)
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Madrid, Spain, 28022
        • Clínica Universidad de Navarra -Madrid
      • Palma de Mallorca, Spain, 07120
        • Hospital Universitari Son Espases
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
    • B
      • Barcelona, B, Spain, 08036
        • Hospital Clinic de Barcelona
    • CC
      • Cáceres, CC, Spain, 10003
        • Hospital San Pedro de Alcántara
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • MU
      • Murcia, MU, Spain, 30120
        • Hospital Universitario Virgen Arrixaca
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • VC
      • Valencia, VC, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
  • Sweden
      • Borås, Sweden, 501 82
        • Södra Älvsborgs Sjukhus
      • Uddevalla, Sweden, 451 51
        • Vastra Goetalandsregionen - Uddevalla Sjukhus (US)
  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • E-Da Cancer Hospital
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation - Kaohsiung Branch
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara Bilkent City Hospital
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Üniversitesi Tıp Fakültesi
      • Istanbul, Turkey (Türkiye), 34381
        • T.C. Istanbul Bilim Universitesi - lstanbul Florence Nightingale Hastanesi
      • Izmir, Turkey (Türkiye), 35100
        • Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital)
      • Izmir, Turkey (Türkiye), 35575
        • Medical Point İzmir Hastanesi
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Universitesi Tıp Fakultesi
      • Yenimahalle, Turkey (Türkiye), 06200
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
      • Çankaya, Turkey (Türkiye), 06680
        • Liv Hospital Ankara
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • NHS Lothian - Western General Hospital
      • London, United Kingdom, W1G 6AF
        • Barts Health NHS Trust - St Bartholomew's Hospital
      • Oxford, United Kingdom, OX4 6LB
        • GenesisCare-Oxford
    • ABD
      • Aberdeen, ABD, United Kingdom, AB25 2ZN
        • NHS Grampian - Aberdeen Royal Infirmary
    • Berkshire
      • Windsor, Berkshire, United Kingdom, SL4 3HD
        • GenesisCare -Windosr
    • DBY
      • Derby, DBY, United Kingdom, DE22 3NE
        • University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
    • DOR
      • Bournemouth, DOR, United Kingdom, BH7 7DW
        • University Hospitals Dorset NHS Foundation Trust (UHD) - Royal Bournemouth Hospital (RBH)
    • HAM
      • Portsmouth, HAM, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • University Hospitals of North Midlands NHS Trust (UHNM) - Royal Stoke University Hospital
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012-5405
        • Rocky Mountain Cancer Centers
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Mayo Clinic Hospital - Florida
      • Tampa, Florida, United States, 33612-9416
        • H. Lee Moffitt Cancer Center & Research Institute
      • Tampa, Florida, United States, 33606
        • Local Institution - 0308
      • Weston, Florida, United States, 33331-3609
        • Cleveland Clinic
    • Georgia
      • Athens, Georgia, United States, 30607-1465
        • University Cancer & Blood Center
      • Atlanta, Georgia, United States, 30322-1013
        • The Winship Cancer Institute of Emory University
      • Augusta, Georgia, United States, 30912
        • Augusta University - Georgia Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1426
        • Local Institution - 0237
    • Kansas
      • Westwood, Kansas, United States, 66205-2003
        • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
    • Maryland
      • Clinton, Maryland, United States, 20735-4230
        • Maryland Oncology Hematology, PA- Clinton
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • University of Michigan - Rogel Cancer Center
      • Detroit, Michigan, United States, 48202-2610
        • Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan (CHCWM)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center (MCCC) - Rochester
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic - Hematology & Oncology
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
    • New York
      • Brooklyn, New York, United States, 11220-3313
        • Perlmutter Cancer Center - Sunset Park
      • Mineola, New York, United States, 11501
        • Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
      • New York, New York, United States, 10016-6402
        • NYU Langone Health
      • New York, New York, United States, 10032-3729
        • Columbia University Medical Center - Herbert Irving Pavilion Location
      • Westbury, New York, United States, 11590-5119
        • Optum Medical Care PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28803-2493
        • Novant Health Cancer Institute - Elizabeth
      • Durham, North Carolina, United States, 27705-3976
        • Duke University Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Cancer Institute Hematology - Forsyth
    • Ohio
      • Cincinnati, Ohio, United States, 45236-2725
        • Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
      • Kansas, Ohio, United States, 64132
        • Midwest Oncology Associates - Kansas City
      • Mayfield Heights, Ohio, United States, 44124
        • Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
      • Toledo, Ohio, United States, 43623
        • Local Institution - 0013
      • Wooster, Ohio, United States, 44691
        • Wooster Milltown Specialty and Surgery Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19111-2433
        • Fox Chase Cancer Center - Jeanes Campus
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0253
    • Tennessee
      • Germantown, Tennessee, United States, 38138-1762
        • West Cancer Center
      • Nashville, Tennessee, United States, 37203-1625
        • Local Institution - 0004
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75390-0001
        • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Confirmed diagnosis of symptomatic multiple myeloma (MM).
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
  • Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
  • Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
  • Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
  • Known central nervous system/meningeal involvement of MM.
  • Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A1: Iberdomide Dose 1
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A2: Iberdomide Dose 2
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A3: Iberdomide Dose 3
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Active Comparator: Arm B: Lenalidomide
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 6 years
Up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
Time Frame: Up to 6 years
Up to 6 years
Overall Survival
Time Frame: Up to 12 years
Up to 12 years
Recommended iberdomide dose for Stage 2
Time Frame: Up to 1 year
Up to 1 year
Area under the iberdomide plasma concentration-time curve from time zero to tau
Time Frame: Up to 1 year
Up to 1 year
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
Time Frame: Up to 1 year
Up to 1 year
Maximum iberdomide concentration (Cmax)
Time Frame: Up to 1 year
Up to 1 year
Time to maximum iberdomide plasma concentration (Tmax)
Time Frame: Up to 1 year
Up to 1 year
Number of participants with adverse events (AEs)
Time Frame: Up to 6 years
Up to 6 years
Progression-free survival on next line of treatment (PFS2)
Time Frame: Up to 6 years
Up to 6 years
Achieving MRD negativity in participants with CR or better at any time after the date of randomization
Time Frame: Up to 6 years
Up to 6 years
Conversion from MRD positive to MRD negative in participants with CR or better
Time Frame: Up to 6 years
Up to 6 years
Time to progression (TTP)
Time Frame: Up to 6 years
Up to 6 years
Time to next treatment (TTNT)
Time Frame: Up to 6 years
Up to 6 years
Best response achieved prior to progressive disease (PD)
Time Frame: Up to 6 years
Up to 6 years
Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)
Time Frame: Up to 6 years
Up to 6 years
Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)
Time Frame: Up to 6 years
Up to 6 years
Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

March 15, 2029

Study Completion (Estimated)

January 1, 2036

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM048-022
  • U1111-1280-9492 (Other Identifier: WHO)
  • 2022-501515-14-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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