AzTrials
AzTrials

Multiple MyelomaPhase 3EXCALIBER-RRMMNCT04975997

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

A Phase 3 study testing Dexamethasone, Daratumumab and Bortezomib in people with Multiple Myeloma, run by Celgene at 259 sites in 31 countries.

Active, not recruiting

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

Official record
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Trial 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). 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?
Dexamethasone, Daratumumab and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
939 participants
Where
259 sitesin 31 countries
Study dates
23 Jun 2022to 25 Jun 2032
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

259 sites in 31 countries.

259 sites in 31 countries

United States43 sites

  • Local Institution - 041

    Alexandria, Louisiana, 71301-3841

  • Local Institution - 018

    Atlanta, Georgia, 30322

  • Local Institution - 687

    Austin, Texas, 78705-1165

  • Local Institution - 698

    Baltimore, Maryland, 21204-6826

  • Local Institution - 682

    Baton Rouge, Louisiana, 70808-4300

  • Local Institution - 027

    Baton Rouge, Louisiana, 70809-3675

  • Local Institution - 014

    Bethesda, Maryland, 20817

  • Local Institution - 046

    Billings, Montana, 59102-6746

  • Local Institution - 010

    Boston, Massachusetts, 02215

  • Local Institution - 645

    Burnsville, Minnesota, 55337-6749

  • Local Institution - 641

    Cerritos, California, 90703-2679

  • Local Institution - 030

    Chattanooga, Tennessee, 37404

  • Local Institution - 038

    Cincinnati, Ohio, 45220

  • Local Institution - 037

    Cleveland, Ohio, 44109

  • Local Institution - 008

    Cleveland, Ohio, 44195

  • Local Institution - 688

    Columbia, Maryland, 21044-3128

  • Local Institution - 036

    Columbus, Ohio, 43214

  • Local Institution - 039

    Durham, North Carolina, 27705

  • Local Institution - 697

    Dyer, Indiana, 46311-1596

  • Local Institution - 640

    Elk Grove Village, Illinois, 60007-3363

  • Local Institution - 029

    Fort Myers, Florida, 33901

  • Local Institution - 681

    Fountain Valley, California, 92708

  • Local Institution - 035

    Hot Springs, Arkansas, 71913

  • Local Institution - 695

    Houston, Texas, 77025

  • Local Institution - 031

    Kansas City, Missouri, 64132

  • Local Institution - 047

    Los Angeles, California, 90033

  • Local Institution - 040

    Louisville, Kentucky, 40207

  • Local Institution - 025

    Madison, Wisconsin, 53705

  • Local Institution - 021

    Nashville, Tennessee, 37203

  • Local Institution - 033

    New Haven, Connecticut, 06511

  • Local Institution - 691

    New York, New York, 10016

  • Local Institution - 684

    Newport, California, 92663

  • Local Institution - 642

    Newport News, Virginia, 23606-3069

  • Local Institution - 693

    Ocala, Florida, 34471-6950

  • Local Institution - 043

    Portland, Oregon, 97239

  • Local Institution - 643

    Roanoke, Virginia, 24014-2419

  • Local Institution - 028

    St. Petersburg, Florida, 33705

  • Local Institution - 015

    Summit, New Jersey, 07901

  • Local Institution - 045

    Tamarac, Florida, 33321-2909

  • Local Institution - 680

    Tulsa, Oklahoma, 74146-6236

  • Local Institution - 034

    West Palm Beach, Florida, 33401

  • Local Institution - 685

    Weston, Florida, 33331-3609

  • Local Institution - 009

    Worcester, Massachusetts, 01655

Other trials in United States

China25 sites

  • Local Institution - 140

    Beijing, 100071

  • Local Institution - 139

    Beijing, 100191

  • Local Institution - 138

    Beijing, 100730

  • Local Institution - 126

    Changchun, 130021

  • Local Institution - 141

    Changsha, Hunan, 410013

  • Local Institution - 121

    Chaoyang District, 100020

  • Local Institution - 135

    Guangzhou, 510030

  • Local Institution - 136

    Guangzhou, 510060

  • Local Institution - 128

    Hangzhou, 310006

  • Local Institution - 120

    Hangzhou, Zhejiang, 310006

  • Local Institution - 127

    Harbin, 150081

  • Local Institution - 129

    Nanchang, Jiangxi, 330008

  • Local Institution - 134

    Nanjing, 210029

  • Local Institution - 142

    Shanghai, Shanghai Municipality, 200434

  • Local Institution - 132

    Shanghai, 200025

  • Local Institution - 130

    Shanghai, 200032

  • Local Institution - 131

    Shenyang, 110004

  • Local Institution - 124

    Suzhu, 215006

  • Local Institution - 145

    Taiyuan, Shanxi, 030032

  • Local Institution - 133

    Tianjin, 300020

  • Local Institution - 144

    Wenzhou, Zhejiang, 325000

  • Local Institution - 137

    Wuhan, 430030

  • Local Institution - 143

    Xi'an, Shaanxi, 710004

  • Local Institution - 125

    Xi'an, 710000

  • Local Institution - 123

    Zhengzhou, 0

Other trials in China

Japan21 sites

  • Local Institution - 912

    Aomori, 030-8553

  • Local Institution - 916

    Chiba, 260-8717

  • Local Institution - 915

    Chuo-shi, Yamanashi, 4093898

  • Local Institution - 911

    Fukuoka, 810-8563

  • Local Institution - 917

    Higashi-Ibaraki-gun, Ibaraki, 311-3193

  • Local Institution - 903

    Kamogawa, 296-8602

  • Local Institution - 902

    Kyoto, 602-8566

  • Local Institution - 900

    Matsuyama, Ehime, 790-8524

  • Local Institution - 910

    Nagoya, 464-8681

  • Local Institution - 901

    Nagoya, 467-8602

  • Local Institution - 920

    Nerima-ku, Tokyo, 179-0072

  • Local Institution - 905

    Okayama, 701-1192

  • Local Institution - 907

    Osaka, 545-8585

  • Local Institution - 908

    Ōsaka-sayama, 589-8511

  • Local Institution - 913

    Sapporo, 003-0006

  • Local Institution - 914

    Sendai, 980-8574

  • Local Institution - 906

    Shibuya-ku, 150-8935

  • Local Institution - 919

    Shimotsuga, Tochigi, 321-0293

  • Local Institution - 918

    Shinagawa-ku, Tokyo, 142-8666

  • Local Institution - 909

    Shinagawa-ku, Tokyo, 141-8625

  • Local Institution - 904

    Toyohashi, 441-8570

Other trials in Japan

Spain17 sites

  • Local Institution - 505

    Barcelona, 08025

  • Local Institution - 502

    Barcelona, 08035

  • Local Institution - 511

    Barcelona, 08916

  • Local Institution - 501

    Cáceres, 10005

  • Local Institution - 509

    Córdoba, 14001

  • Local Institution - 510

    Madrid, 28006

  • Local Institution - 516

    Madrid, 28027

  • Local Institution - 504

    Madrid, 28034

  • Local Institution - 513

    Madrid, 28040

  • Local Institution - 503

    Málaga, 29010

  • Local Institution - 508

    Murcia, 30120

  • Local Institution - 506

    Oviedo, 33011

  • Local Institution - 514

    Pamplona, Navarre, 31008

  • Local Institution - 515

    Salamanca, 37007

  • Local Institution - 500

    Santiago de Compostela, 15706

  • Local Institution - 512

    Valencia, 46026

  • Local Institution - 507

    Zaragoza, 50009

Other trials in Spain

Australia12 sites

  • Local Institution - 803

    Adelaide, South Australia, 5000

  • Local Institution - 806

    Bedford Park, South Australia, 5042

  • Local Institution - 813

    Birtinya, Queensland, 4575

  • Local Institution - 804

    Camperdown, 2050

  • Local Institution - 802

    Clayton, Victoria, 3168

  • Local Institution - 812

    Douglas, Queensland, 4814

  • Local Institution - 809

    East Melbourne, Victoria, 3001

  • Local Institution - 800

    Fitzroy, 3065

  • Local Institution - 808

    Garran, ACT 2605

  • Local Institution - 801

    Melbourne, Victoria, 3004

  • Local Institution - 811

    Murdoch, Western Australia, 6150

  • Local Institution - 807

    West Perth, Western Australia, 6005

Other trials in Australia

Italy12 sites

  • Local Institution - 400

    Bologna, 40138

  • Local Institution - 408

    Catania, 95124

  • Local Institution - 414

    Genova, 16132

  • Local Institution - 404

    Milan, 20122

  • Local Institution - 410

    Novara, 28100

  • Local Institution - 412

    Pavia, 27100

  • Local Institution - 402

    Pisa, 56126

  • Local Institution - 405

    Reggio Calabria, 89100

  • Local Institution - 401

    Roma, 00189

  • Local Institution - 415

    Rome, Lazio, 00193

  • Local Institution - 403

    San Giovanni Rotondo FG, 71013

  • Local Institution - 406

    Udine, 33100

Other trials in Italy

United Kingdom11 sites

  • Local Institution - 705

    Belfast Northern Ireland, BT9 7AD

  • Local Institution - 700

    Birmingham, B15 2TH

  • Local Institution - 707

    Canterbury Kent, CT1 3NG

  • Local Institution - 704

    Lancashire Blackpool, FY3 8NR

  • Local Institution - 701

    London, NW1 2BU

  • Local Institution - 709

    London, SE1 9RT

  • Local Institution - 702

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution - 706

    Oxford, OX3 7LE

  • Local Institution - 711

    Portsmouth, PO6 3LY

  • Local Institution - 713

    Sutton, SM2 5PT

  • Local Institution - 708

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France10 sites

  • Local Institution - 463

    Argenteuil, 95100

  • Local Institution - 462

    La Roche-sur-Yon, 85925

  • Local Institution - 451

    Lille, 59037

  • Local Institution - 458

    Nancy, 54511

  • Local Institution - 454

    Nantes, 44093

  • Local Institution - 456

    Paris, 75013

  • Local Institution - 452

    Paris, 75475

  • Local Institution - 464

    Pessac, 33604

  • Local Institution - 465

    Rouen, 76038

  • Local Institution - 457

    Toulouse, 31059

Other trials in France

Brazil9 sites

  • Local Institution - 051

    Barretos, São Paulo, 14784-400

  • Local Institution - 056

    Curitiba, Paraná, 80530-010

  • Local Institution - 054

    Jaú, São Paulo, 17210-080

  • Local Institution - 050

    Porto Alegre, Rio Grande do Sul, 90460-030

  • Local Institution - 058

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 053

    Rio de Janeiro, 22793-080

  • Local Institution - 055

    São Paulo, São Paulo, 05403000

  • Local Institution - 057

    São Paulo, 01509-900

  • Local Institution - 052

    São Paulo, 04537-080

Other trials in Brazil

Canada9 sites

  • Local Institution - 111

    Calgary, Alberta, T2N 4N2

  • Local Institution - 103

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 101

    Halifax, Nova Scotia, B3H 1V7

  • Local Institution - 109

    Ottawa, Quebec, K1H 8L6

  • Local Institution - 108

    Québec, Quebec, G1J 1Z4

  • Local Institution - 104

    Saint John, New Brunswick, E2L 3L6

  • Local Institution - 107

    Saskatoon, Saskatchewan, S7N-0W8

  • Local Institution - 110

    St. John's, Newfoundland and Labrador, A1B3V6

  • Local Institution - 112

    Surrey, British Columbia, V3V 1Z2

Other trials in Canada

Turkey (Türkiye)9 sites

  • Local Institution - 770

    Ankara, 06100

  • Local Institution - 771

    Balçova, İzmir, 35340

  • Local Institution - 775

    Bornova, İzmir, 35100

  • Local Institution - 772

    Gaziantep, 27310

  • Local Institution - 778

    Kavaklıdere, Ankara, 06680

  • Local Institution - 774

    Kayseri, 38140

  • Local Institution - 777

    Pendik, Istanbul, 34899

  • Local Institution - 773

    Samsun, Kurupelit, 55239

  • Local Institution - 776

    Yenimahalle, Ankara, 6200

Other trials in Turkey (Türkiye)

South Korea8 sites

  • Local Institution - 974

    Daegu, 700-721

  • Local Institution - 973

    Gyeonggi-do, 410-769

  • Local Institution - 975

    Hwasun-gun, 519-809

  • Local Institution - 971

    Seoul, 06351

  • Local Institution - 976

    Seoul, 06591

  • Local Institution - 972

    Seoul, 120-752

  • Local Institution - 970

    Seoul, 3080

  • Local Institution - 977

    Seoul, 5505

Other trials in South Korea

Taiwan7 sites

  • Local Institution - 955

    Niao-Sung Hsiang Kaohsiung County, 83301

  • Local Institution - 952

    Taichung, 40447

  • Local Institution - 954

    Taichung, 407219

  • Local Institution - 951

    Tainan, Taiana, 704

  • Local Institution - 950

    Taipei, 11217

  • Local Institution - 956

    Taipei, Zhongzheng Dist., 10002

  • Local Institution - 953

    Taoyuan City, 33305

Other trials in Taiwan

Austria6 sites

  • Local Institution - 155

    Graz, 73013

  • Local Institution - 154

    Linz, 4010

  • Local Institution - 153

    Salzburg, 5020

  • Local Institution - 156

    Sankt Pölten, 3100

  • Local Institution - 150

    Vienna, 1090

  • Local Institution - 151

    Vienna, 1160

Other trials in Austria

Germany6 sites

  • Local Institution - 301

    Frankfurt am Main, 60590

  • Local Institution - 300

    Hamburg, 20246

  • Local Institution - 302

    Hamburg, 22763

  • Local Institution - 305

    Heidelberg, 69120

  • Local Institution - 308

    Kiel, Schleswig-Holstein, 24105

  • Local Institution - 304

    Lübeck, 23562

Other trials in Germany

India6 sites

  • Local Institution - 930

    Bangalore, Karnataka, 560054

  • Local Institution - 934

    Ernākulam, Kerala, 682041

  • Local Institution - 932

    Hyderabad, Andhra Pradesh, 500084

  • Local Institution - 935

    Kolkata, West Bengal, 700014

  • Local Institution - 933

    Mumbai, Maharashtra, 400036

  • Local Institution - 931

    Puducherry, 605006

Other trials in India

Poland6 sites

  • Local Institution - 631

    Bialystok, Podlaskie Voivodeship, 15-276

  • Local Institution - 633

    Krakow, 30-688

  • Local Institution - 635

    Nowy Sącz, 33-300

  • Local Institution - 634

    Poznan, 60-569

  • Local Institution - 636

    Wałbrzych, 58-309

  • Local Institution - 630

    Warsaw, 02-781

Other trials in Poland

Greece5 sites

  • Local Institution - 571

    Athens, 115 28

  • Local Institution - 573

    Pátrai, Achaea, 26054

  • Local Institution - 574

    Pátrai, Achaia, 264 43

  • Local Institution - 572

    Thessaloniki, 54007

  • Local Institution - 570

    Thessaloniki, 57010

Other trials in Greece

Israel5 sites

  • Local Institution - 874

    Afula, Northern District, 18101

  • Local Institution - 872

    Haifa, 35254

  • Local Institution - 871

    Jerusalem, 91120

  • Local Institution - 870

    Tel Aviv, 64239

  • Local Institution - 873

    Tel Litwinsky, 52621

Other trials in Israel

Portugal5 sites

  • Local Institution - 545

    Coimbra, 4200-072

  • Local Institution - 543

    Lisbon, 1099-023

  • Local Institution - 544

    Lisbon, 1400-038

  • Local Institution - 540

    Porto, 4200-072

  • Local Institution - 541

    Porto, 4200-319

Other trials in Portugal

Czechia3 sites

  • Local Institution - 601

    Brno, 625 00

  • Local Institution - 600

    Ostrava-Poruba, 708 52

  • Local Institution - 602

    Prague, 128 08

Other trials in Czechia

Denmark3 sites

  • Local Institution - 371

    Aalborg, 9000

  • Local Institution - 370

    Odense, 5000

  • Local Institution - 372

    Roskilde, 4000

Other trials in Denmark

Finland3 sites

  • Local Institution - 230

    Helsinki, 290

  • Local Institution - 232

    Oulu, 90220

  • Local Institution - 231

    Turku, Southwest Finland, 20521

Other trials in Finland

Ireland3 sites

  • Local Institution - 752

    Cork, T12 DFK4

  • Local Institution - 750

    Dublin, D09 V2N0

  • Local Institution - 751

    Galway, H91 YR71

Other trials in Ireland

Netherlands3 sites

  • Local Institution - 354

    Amsterdam, 1081 HV

  • Local Institution - 351

    Dordrecht, South Holland, 3318 AT

  • Local Institution - 352

    The Hague, 2545 CH

Other trials in Netherlands

Norway3 sites

  • Local Institution - 202

    Bergen, N-5053

  • Local Institution - 200

    Oslo, 0450

  • Local Institution - 201

    Trondheim, 7030

Other trials in Norway

Argentina2 sites

  • Local Institution - 080

    Ciudad Autanoma de Buenos Aires, Buenos Aires, C1199ABB

  • Local Institution - 083

    Villa Elisa, Buenos Aires, B1894

Other trials in Argentina

Belgium2 sites

  • Local Institution - 172

    Bruges, 8000

  • Local Institution - 174

    Brussels, 1200

Other trials in Belgium

Sweden2 sites

  • Local Institution - 272

    Borås, 50182

  • Local Institution - 271

    Helsingborg, 25437

Other trials in Sweden

Switzerland2 sites

  • Local Institution - 851

    Chur, 7000

  • Local Institution - 850

    Sankt Gallen, CH-9007

Other trials in Switzerland

Mexico1 site

  • Local Institution - 183

    Guadalajara, Jalisco, 44600

Other trials in Mexico

About this study

Official title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

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).

Read the detailed description

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

  • Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
  • Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Being tested
Dexamethasone, Daratumumab, Bortezomib, Iberdomide
Keywords
Iberdomide, CC-220, Daratumumab, Darzalex Faspro, Bortezomib, Velcade, Dexamethasone, MM, Multiple Myeloma, RRMM, 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.

  • DexamethasoneDrug

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

  • DaratumumabDrug

    Also called DARZALEX FASPRO

    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

  • BortezomibDrug

    Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

  • IberdomideDrug

    Also called CC-220, BMS-986382

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

  • IberdomideDrug

    Also called CC-220, BMS-986382

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

  • IberdomideDrug

    Also called CC-220, BMS-986382

    Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

  • DexamethasoneDrug

    Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8

  • DaratumumabDrug

    Also called DARZALEX FASPRO

    Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.

Study groups in NCT04975997
Study groupRoleWhat they receive
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1ExperimentalParticipants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
Receives: Drug: Dexamethasone; Drug: Daratumumab; Drug: Iberdomide
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2ExperimentalNot described
Receives: Drug: Dexamethasone; Drug: Daratumumab; Drug: Iberdomide
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3ExperimentalNot described
Receives: Drug: Dexamethasone; Drug: Daratumumab; Drug: Iberdomide
Daratumumab in combination with dexamethasone and bortezomibActive comparatorParticipants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
Receives: Drug: Dexamethasone; Drug: Bortezomib; Drug: Daratumumab

What is being measured

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

  1. Progression-free Survival (PFS)

    To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).

    Measured: Up to approximately 5 years

  2. Minimal Residual Disease (MRD) negative Complete Response (CR) at any time

    To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.

    Measured: Up to approximately 5 years

Secondary outcomes (15)

  1. Overall Survival (OS)

    To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).

    Measured: Up to approximately 5 years

  2. Sustainability of Minimal Residual Disease (MRD) negativity

    To evaluate the sustainability of minimal residual disease (MRD) negativity.

    Measured: Up to approximately 5 years

  3. Overall Response Rate (ORR)

    Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.

    Measured: Up to approximately 5 years

  4. Time to response (TTR)

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

    Measured: Up to approximately 5 years

  5. Duration of Response (DoR)

    Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  6. Time to Progression (TTP)

    The time from randomization to the first documented disease progression.

    Measured: Up to approximately 5 years

  7. Time to Next Treatment (TTNT)

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

    Measured: Up to approximately 5 years

  8. Progression-free Survival 2 (PFS2)

    Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  9. Safety

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

    Measured: Up to approximately 5 years

  10. European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)

    Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.

    Measured: Up to approximately 5 years

  11. European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)

    EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.

    Measured: Up to approximately 5 years

  12. Recommended iberdomide dose for Stage 2

    Measured: Up to approximately 1 year

  13. Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))

    Measured: Up to approximately 1 year

  14. Maximum plasma concentration (Cmax)

    Measured: Up to approximately 1 year

  15. Time to maximum plasma concentration (Tmax)

    Measured: Up to approximately 1 year

Timeline

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

  1. First posted26 Jul 2021
  2. Study start23 Jun 2022
  3. Primary completion16 Nov 2027 (estimated)
  4. Study completion25 Jun 2032 (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
939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975997
Sponsor's protocol ID
CC-220-MM-002
Other IDs
U1111-1260-2872, 2020-000431-49
Acronym
EXCALIBER-RRMM
Status last verified
Mar 2026
First submitted
2 Jul 2021
Last updated
3 Apr 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

Publications

  • Lonial S, Dimopoulos MA, Gavriatopoulou M, Kim K, Min CK, Oriol A, Moreira CCC, Quach H, Qiu L, Xia Z, Schjesvold F, Casas-Aviles I, Xu Y, Hungria V, Seval GC, Fang B, Kyriakou C, Prince HM, Zhuang J, Lin HC, Mateos MV, Spicka I, Maiolino A, Vural F, Basu S, Dytfeld D, Fu C, Ho PJ, Joseph N, Low M, Pour L, Girnius S, Berdeja JG, Otero PR, Cheng Y, Amatangelo M, Hersey S, Kazanecki C, Weisskopf MB, Kyada MJ, Abad PC, Chu S, Morando J, Maciag P, Richardson PG, van de Donk NW; EXCALIBER-RRMM Investigators. Iberdomide plus daratumumab and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (EXCALIBER-RRMM): an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Sep 25:S1470-2045(26)00450-X. doi: 10.1016/S1470-2045(26)00450-X. Online ahead of print.

    PubMed 42790445

  • Lonial S, Dimopoulos MA, Berdeja JG, Richardson PG, Quach H, Rodriguez-Otero P, Maciag P, Hong K, Amatangelo M, Chen M, van de Donk NWCJ. EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma. Future Oncol. 2025 Jun;21(14):1761-1769. doi: 10.1080/14796694.2025.2501920. Epub 2025 May 10.

    PubMed 40346992

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone, Daratumumab and Bortezomib in people with Multiple Myeloma, run by Celgene at 259 sites in 31 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 259 sites in United States, China, Japan, Spain, Australia and 26 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 approximately 5 years). The study lists 2 primary outcomes in all. 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 NCT04975997, which also lists 2 linked publications.

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 3 Apr 2026.

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EXCALIBER-RRMM Clinical Trial NCT04975997 | AzTrials