AzTrials
AzTrials

Multiple MyelomaPhase 3NCT05827016

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

A Phase 3 study testing Iberdomide and Lenalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 269 sites in 34 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Iberdomide and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,230 participants
Where
269 sitesin 34 countries
Study dates
22 Jun 2023to 1 Jan 2036
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

269 sites in 34 countries.

269 sites in 34 countries

United States44 sites

  • Local Institution - 0001

    Ann Arbor, Michigan, 48109-5000

  • Local Institution - 0019

    Athens, Georgia, 30607-1465

  • Local Institution - 0018

    Atlanta, Georgia, 30322-1013

  • Local Institution - 0021

    Augusta, Georgia, 30912

  • Local Institution - 0202

    Aurora, Colorado, 80012-5405

  • Local Institution - 0328

    Brooklyn, New York, 11220-3313

  • Local Institution - 0331

    Charlotte, North Carolina, 28204

  • Local Institution - 0005

    Charlotte, North Carolina, 28803-2493

  • Local Institution - 0237

    Chicago, Illinois, 60637-1426

  • Local Institution - 0238

    Cincinnati, Ohio, 45236-2725

  • Local Institution - 0299

    Cleveland, Ohio, 44111

  • Local Institution - 0002

    Cleveland, Ohio, 44195

  • Local Institution - 0205

    Clinton, Maryland, 20735-4230

  • Local Institution - 0193

    Dallas, Texas, 75246

  • Local Institution - 0009

    Dallas, Texas, 75390-0001

  • Local Institution - 0257

    Detroit, Michigan, 48202-2610

  • Local Institution - 0281

    Durham, North Carolina, 27705-3976

  • Local Institution - 0203

    Eugene, Oregon, 97401

  • Local Institution - 0294

    Germantown, Tennessee, 38138-1762

  • Local Institution - 0296

    Grand Rapids, Michigan, 49503

  • Local Institution - 0207

    Hattiesburg, Mississippi, 39401

  • Local Institution - 0006

    Houston, Texas, 77030

  • Local Institution - 0007

    Jacksonville, Florida, 32224-1865

  • Local Institution - 0017

    Kansas, Ohio, 64132

  • Local Institution - 0301

    Mayfield Heights, Ohio, 44124

  • Local Institution - 0288

    Mineola, New York, 11501

  • Local Institution - 0191

    Morristown, New Jersey, 07960

  • Local Institution - 0004

    Nashville, Tennessee, 37203-1625

  • Local Institution - 0180

    New York, New York, 10016-6402

  • Local Institution - 0020

    New York, New York, 10032-3729

  • Local Institution - 0012

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0011

    Philadelphia, Pennsylvania, 19111-2433

  • Local Institution - 0253

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0303

    Rochester, Minnesota, 55905

  • Local Institution - 0308

    Tampa, Florida, 33606

  • Local Institution - 0192

    Tampa, Florida, 33612-9416

  • Local Institution - 0013

    Toledo, Ohio, 43623

  • Local Institution - 0274

    Westbury, New York, 11590-5119

  • Local Institution - 0003

    Weston, Florida, 33331-3609

  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

    Westwood, Kansas, 66205-2003

  • Local Institution - 0286

    Winston-Salem, North Carolina, 27103

  • Local Institution - 0322

    Winston-Salem, North Carolina, 27157

  • Local Institution - 0300

    Wooster, Ohio, 44691

  • Local Institution - 0279

    Worcester, Massachusetts, 01655

Other trials in United States

China36 sites

  • Local Institution - 0229

    Beijing, Beijing Municipality, 100071

  • Local Institution - 0326

    Beijing, BJ, 100038

  • Local Institution - 0100

    Beijing, 100020

  • Local Institution - 0216

    Beijing, 100044

  • Local Institution - 0091

    Changchun, JL, 130021

  • Local Institution - 0262

    Changsha, HN, 410013

  • Local Institution - 0282

    Changsha, HN, 410013

  • Local Institution - 0234

    Changsha, 400011

  • Local Institution - 0242

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0321

    Chongqing, CQ, 400030

  • Local Institution - 0273

    Fuzhou, 350001

  • Local Institution - 0304

    Guangzhou, GD, 510515

  • Local Institution - 0261

    Guangzhou, Guangdong, 510080

  • Local Institution - 0079

    Guangzhou, 511363

  • Local Institution - 0243

    Hangzhou, ZJ, 310003

  • Local Institution - 0196

    Hefei, AH, 230001

  • Local Institution - 0240

    Jinan, SD, 250012

  • Local Institution - 0212

    Jinan, 250021

  • Local Institution - 0263

    Nanchang, Jiangxi, 330200

  • Local Institution - 0266

    Nanjing, Jiangsu, 210008

  • Local Institution - 0231

    Nanjing, 210029

  • Local Institution - 0320

    Ningbo, ZJ, 315010

  • Local Institution - 0077

    Qingdao, 266071

  • Local Institution - 0319

    Shanghai, SH, 200434

  • Local Institution - 0223

    Shanghai, 200025

  • Local Institution - 0094

    Shenyang, Liaoning, 110022

  • Local Institution - 0256

    Shenzhen, Guangdong, 518028

  • Local Institution - 0305

    Suzhou, 215006

  • Local Institution - 0249

    Tianjin, Tianjin Municipality, 300060

  • Local Institution - 0087

    Wenzhou, 325000

  • Local Institution - 0248

    Wuhan, 430022

  • Local Institution - 0084

    Wuhan, 430030

  • Local Institution - 0265

    Xi'an, Shaanxi, 710032

  • Local Institution - 0318

    Xi'an, Shaanxi, 710061

  • Local Institution - 0239

    Xuzhou, Jiangsu, 221000

  • Local Institution - 0246

    Zhengzhou, Henan, 450003

Other trials in China

Japan22 sites

  • Local Institution - 0141

    Chiba, 260-8677

  • Local Institution - 0118

    Gifu, 500-8513

  • Local Institution - 0112

    Hiroshima, 730-8619

  • Local Institution - 0199

    Isehara-shi, 259-1193

  • Local Institution - 0330

    Itabashi-Ku, 173-8610

  • Local Institution - 0111

    Kagoshima, 890-8520

  • Local Institution - 0197

    Kamakura-Shi, Kanagawa, 2478533

  • Local Institution - 0144

    Kanazawa, 920-8641

  • Local Institution - 0122

    Kōtoku, 135-8550

  • Local Institution - 0198

    Kumamoto, Kumamoto, 860-8556

  • Local Institution - 0121

    Maebashi, 371-8511

  • Local Institution - 0150

    Minatoku, 105-8471

  • Local Institution - 0104

    Nagasaki, 852-8511

  • Local Institution - 0143

    Nagoya, 467-8602

  • Local Institution - 0329

    Nerima-Ku, 179-0072

  • Local Institution - 0148

    Saitama-Shi, 330-0834

  • Local Institution - 0268

    Sakaishi, 590-0197

  • Local Institution - 0105

    Sapporo, 003-0006

  • Local Institution - 0132

    Sendai, 983-8520

  • Local Institution - 0106

    Shibukawa-shi, Gunma, 3770280

  • Local Institution - 0116

    Shibuya-ku, 150-8935

  • Local Institution - 0130

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Germany14 sites

  • Local Institution - 0324

    Augsburg, Bavaria, 86156

  • Klinikum Bayreuth GmbH

    Bayreuth, Bavaria, 95445

  • Local Institution - 0037

    Berlin, State of Berlin, 12203

  • Local Institution - 0316

    Chemnitz, Saxony, 09116

  • Carl-Thiem-Klinikum Cottbus GmbH

    Cottbus, Brandenburg, 03048

  • Universitaetsklinikum Erlangen - Medizinische Klinik 5

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Local Institution - 0315

    Hamburg, Free and Hanseatic City of Hamburg, 22763

  • Local Institution - 0297

    Hamburg, 20246

  • Local Institution - 0026

    Hamm, 59073

  • Local Institution - 0038

    Jena, 07747

  • LMU Klinikum der Universitaet Muenchen - Campus Grosshadern - Transplantation

    Munich, Bavaria, 81377

  • Local Institution - 0040

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Italy11 sites

  • Local Institution - 0053

    Catania, CT, 95123

  • Local Institution - 0306

    Florence, FI, 50134

  • Local Institution - 0115

    Genova, GE, 16132

  • Local Institution - 0188

    Milan, MI, 20122

  • Local Institution - 0071

    Milan, MI, 20162

  • Local Institution - 0074

    Naples, 80131

  • Local Institution - 0278

    Pavia, 27100

  • Local Institution - 0139

    Pisa, PI, 56127

  • Local Institution - 0046

    Roma, RM, 00168

  • Policlinico Umberto I

    Rome, 00161

  • Local Institution - 0140

    Torino, TO, 10126

Other trials in Italy

Brazil10 sites

  • Local Institution - 0190

    Barretos, 14784-400

  • Local Institution - 0214

    Niterói, Rio de Janeiro, 24020-096

  • Local Institution - 0083

    Porto Alegre, 90880-480

  • Local Institution - 0081

    Ribeirão Preto, São Paulo, 14051-140

  • Local Institution - 0082

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Local Institution - 0096

    Rio de Janeiro, 21941-913

  • Local Institution - 0098

    Salvador, 40110-150

  • Local Institution - 0277

    São Paulo, São Paulo, 04537-080

  • Local Institution - 0194

    São Paulo, São Paulo, 05403-000

  • Local Institution - 0241

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

France10 sites

  • Local Institution - 0030

    Amiens, 80000

  • Local Institution - 0055

    Caen, 14033

  • Local Institution - 0050

    Créteil, 94000

  • Local Institution - 0236

    La Roche-sur-Yon, 85000

  • Local Institution - 0054

    Lille, 59037

  • Local Institution - 0221

    Limoges, 87042

  • Local Institution - 0272

    Nantes, 44093

  • Local Institution - 0219

    Paris, 75012

  • Local Institution - 0228

    Paris, 75013

  • Local Institution - 0051

    Toulouse, 31059

Other trials in France

Spain10 sites

  • Local Institution - 0232

    Badalona, 08916

  • Hospital Clínic de Barcelona

    Barcelona, B, 08036

  • Local Institution - 0169

    Cáceres, CC, 10003

  • Local Institution - 0172

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Local Institution - 0317

    Madrid, 28022

  • Local Institution - 0155

    Murcia, MU, 30120

  • Local Institution - 0166

    Oviedo, Principality of Asturias, 33011

  • Local Institution - 0164

    Palma de Mallorca, 07120

  • Local Institution - 0163

    Pamplona, 31008

  • Local Institution - 0174

    Valencia, VC, 46026

Other trials in Spain

India9 sites

  • Local Institution - 0110

    Bangalore, Karnataka, 560027

  • Local Institution - 0124

    Bhubaneswar, Odisha, 751007

  • Local Institution - 0128

    Chandigarh, Chandigarh, 160012

  • Local Institution - 0109

    Kochi, Kerala, 68202

  • Local Institution - 0200

    Kolhāpur, Maharashtra, 416005

  • Local Institution - 0125

    Kolkata, West Bengal, 700160

  • Local Institution - 0152

    Nagpur, Maharashtra, 440030

  • Local Institution - 0123

    Pune, Maharashtra, 411 004

  • Local Institution - 0142

    Pune, Maharashtra, 411004

Other trials in India

United Kingdom9 sites

  • Local Institution - 0173

    Aberdeen, ABD, AB25 2ZN

  • Local Institution - 0162

    Bournemouth, DOR, BH7 7DW

  • Local Institution - 0156

    Derby, DBY, DE22 3NE

  • Local Institution - 0160

    Edinburgh, EH4 2XU

  • Local Institution - 0025

    London, W1G 6AF

  • Local Institution - 0029

    Oxford, OX4 6LB

  • Local Institution - 0284

    Portsmouth, HAM, PO6 3LY

  • Local Institution - 0154

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Local Institution - 0161

    Windsor, Berkshire, SL4 3HD

Other trials in United Kingdom

Israel8 sites

  • Local Institution - 0057

    Ashdod, 7747629

  • Local Institution - 0137

    Beer Ya'Aqov, 70300

  • Local Institution - 0027

    Hadera, 38100

  • Local Institution - 0047

    Haifa, 3109601

  • Local Institution - 0075

    Jerusalem, 91031

  • Local Institution - 0060

    Jerusalem, 9112001

  • Local Institution - 0108

    Petah Tikva, 49100

  • Local Institution - 0131

    Ramat Gan, 52621

Other trials in Israel

Poland8 sites

  • Local Institution - 0149

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Local Institution - 0327

    Bydgoszcz, 85-048

  • Local Institution - 0195

    Gdansk, 80-214

  • Local Institution - 0252

    Gliwice, 44-102

  • Local Institution - 0039

    Katowice, 40-519

  • Local Institution - 0059

    Lodz, Łódź Voivodeship, 93-510

  • Local Institution - 0044

    Lublin, 20-134

  • Local Institution - 0119

    Warsaw, 02-781

Other trials in Poland

Turkey (Türkiye)8 sites

  • Local Institution - 0167

    Ankara, 06230

  • Local Institution - 0287

    Çankaya, 06680

  • Local Institution - 0052

    Edirne, 22030

  • Local Institution - 0309

    Istanbul, 34381

  • Local Institution - 0158

    Izmir, 35100

  • Local Institution - 0073

    Izmir, 35575

  • Local Institution - 0024

    Kayseri, 38039

  • Local Institution - 0032

    Yenimahalle, 06200

Other trials in Turkey (Türkiye)

Colombia6 sites

  • Local Institution - 0217

    Bogotá, 110111

  • Local Institution - 0211

    Bogotá, 110131

  • Local Institution - 0101

    Floridablanca, 681004

  • Local Institution - 0179

    Medellín, 050034

  • Local Institution - 0302

    Montería, COR, 230002

  • Local Institution - 0093

    Valledupar, 200001

Other trials in Colombia

Greece6 sites

  • Local Institution - 0185

    Athens, I, 106 76

  • Local Institution - 0233

    Athens, 115 28

  • Local Institution - 0290

    Larissa, 411 10

  • Local Institution - 0097

    Rio, G, 265 04

  • Local Institution - 0209

    Thessaloniki, B, 570 10

  • Local Institution - 0063

    Thessaloniki, 546 39

Other trials in Greece

South Korea6 sites

  • Local Institution - 0145

    Busan, 49241

  • Local Institution - 0113

    Goyang-si, 410-769

  • Local Institution - 0293

    Seongnam-si, Gyeonggi-do, 13620

  • Local Institution - 0295

    Seoul, 03722

  • Local Institution - 0114

    Seoul, 06351

  • Local Institution - 0225

    Ulsan, 44033

Other trials in South Korea

Taiwan6 sites

  • Local Institution - 0175

    Kaohsiung City, 82445

  • Local Institution - 0153

    Kaohsiung City, 83301

  • Local Institution - 0159

    New Taipei City, 220

  • Local Institution - 0165

    Tainan, 704

  • Local Institution - 0292

    Taipei, 10002

  • Local Institution - 0289

    Taoyuan, 333

Other trials in Taiwan

Romania5 sites

  • Local Institution - 0117

    Bucharest, B, 022328

  • Local Institution - 0064

    Cluj-Napoca, Jud. Cluj, 400015

  • Local Institution - 0072

    Cluj-Napoca, 400015

  • Local Institution - 0043

    Craiova, Dolj, 200143

  • Local Institution - 0224

    Iași, IS, 700483

Other trials in Romania

Argentina4 sites

  • Local Institution - 0183

    Ciudad Autonoma Buenos Aires, Buenos Aires F.D., C1199ABB

  • Local Institution - 0227

    Ciudad Autonoma Buenos Aires, Buenos Aires F.D., C1430EFA

  • Local Institution - 0182

    Córdoba, X5000JHGQ

  • Local Institution - 0267

    Pilar, B, B1629AHJ

Other trials in Argentina

Australia4 sites

  • Local Institution - 0088

    Adelaide, South Australia, 5000

  • Local Institution - 0220

    Box Hill, Victoria, 3128

  • Local Institution - 0078

    Clayton, Victoria, 3800

  • Local Institution - 0244

    Waratah, 2298

Other trials in Australia

Austria4 sites

  • Local Institution - 0058

    Linz, 4020

  • Local Institution - 0034

    Sankt Pölten, 3100

  • Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie

    Vienna, 1090

  • Hanusch-Krankenhaus

    Vienna, 1140

Other trials in Austria

Canada4 sites

  • Local Institution - 0270

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0307

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0208

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 0210

    Québec, Quebec

Other trials in Canada

Czechia4 sites

  • Local Institution - 0036

    Brno, 625 00

  • Local Institution - 0206

    Olomouc, 779 00

  • Local Institution - 0215

    Prague, 100 34

  • Local Institution - 0069

    Prague, 128 08

Other trials in Czechia

Chile3 sites

  • Local Institution - 0186

    Santiago, 7500691

  • Local Institution - 0258

    Temuco, 4800827

  • Local Institution - 0099

    Vitacura, 7650567

Other trials in Chile

Portugal3 sites

  • Local Institution - 0023

    Braga, 4710-243

  • Local Institution - 0151

    Coimbra, 3000-075

  • Instituto Português Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Belgium2 sites

  • Local Institution - 0035

    Charleroi, WHT, 6060

  • Local Institution - 0048

    Kortrijk, 8500

Other trials in Belgium

Finland2 sites

  • Local Institution - 0276

    Helsinki, 00290

  • Local Institution - 0201

    Kuopio, 70211

Other trials in Finland

Mexico2 sites

  • Local Institution - 0283

    Monterrey, Nuevo León, 64460

  • Local Institution - 0146

    Toluca, State of Mexico, 50090

Other trials in Mexico

Netherlands2 sites

  • Local Institution - 0129

    Amsterdam, North Holland, 1081 HV

  • Local Institution - 0070

    Dordrecht, 3300 AK

Other trials in Netherlands

Singapore2 sites

  • Local Institution - 0138

    Singapore, 119074

  • Local Institution - 0187

    Singapore, 169608

Other trials in Singapore

Sweden2 sites

  • Local Institution - 0230

    Borås, 501 82

  • Local Institution - 0291

    Uddevalla, 451 51

Other trials in Sweden

Denmark1 site

  • Local Institution - 0028

    Odense, 5000

Other trials in Denmark

Hong Kong1 site

  • Local Institution - 0250

    Hong Kong, HK, 000000

Other trials in Hong Kong

Hungary1 site

  • Local Institution - 0062

    Debrecen, HB, 4032

Other trials in Hungary

About this study

Official title: 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).

Being tested
Iberdomide, Lenalidomide
Keywords
Multiple Myeloma, Iberdomide, CC-220, Lenalidomide, MM, NDMM, Maintenance, Autologous stem cell transplant, ASCT, CELMoD, Cereblon Modulators
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IberdomideDrug

    Also called CC-220, BMS-986382

    Specified dose on specified days

  • LenalidomideDrug

    Also called Revlimid®

    Specified dose on specified days

Study groups in NCT05827016
Study groupRoleWhat they receive
Arm A1: Iberdomide Dose 1ExperimentalNot described
Receives: Drug: Iberdomide
Arm A2: Iberdomide Dose 2ExperimentalNot described
Receives: Drug: Iberdomide
Arm A3: Iberdomide Dose 3ExperimentalNot described
Receives: Drug: Iberdomide
Arm B: LenalidomideActive comparatorNot described
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: Up to 6 years

Secondary outcomes (17)

  1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment

    Measured: Up to 6 years

  2. Overall Survival

    Measured: Up to 12 years

  3. Recommended iberdomide dose for Stage 2

    Measured: Up to 1 year

  4. Area under the iberdomide plasma concentration-time curve from time zero to tau

    Measured: Up to 1 year

  5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)

    Measured: Up to 1 year

  6. Maximum iberdomide concentration (Cmax)

    Measured: Up to 1 year

  7. Time to maximum iberdomide plasma concentration (Tmax)

    Measured: Up to 1 year

  8. Number of participants with adverse events (AEs)

    Measured: Up to 6 years

  9. Progression-free survival on next line of treatment (PFS2)

    Measured: Up to 6 years

  10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization

    Measured: Up to 6 years

  11. Conversion from MRD positive to MRD negative in participants with CR or better

    Measured: Up to 6 years

  12. 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

    Measured: Up to 6 years

  13. Time to progression (TTP)

    Measured: Up to 6 years

  14. Time to next treatment (TTNT)

    Measured: Up to 6 years

  15. Best response achieved prior to progressive disease (PD)

    Measured: Up to 6 years

  16. 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)

    Measured: Up to 6 years

  17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start22 Jun 2023
  3. Primary completion15 Mar 2029 (estimated)
  4. Study completion1 Jan 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827016
Sponsor's protocol ID
IM048-022
Other IDs
U1111-1280-9492, 2022-501515-14-00
Status last verified
Sep 2026
First submitted
11 Apr 2023
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iberdomide and Lenalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 269 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, China, Japan, Germany, Italy and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05827016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05827016 | AzTrials