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AzTrials

Multiple MyelomaPhase 3CERVINONCT06158841

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Etentamig, Carfilzomib and Pomalidomide in people with Multiple Myeloma, run by AbbVie at 166 sites in 25 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

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. 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?
Etentamig, Carfilzomib and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
166 sitesin 25 countries
Study dates
19 May 2024to Dec 2027
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

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
  • Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
  • Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
  • Serum M-protein >= 0.5 g/dL (>= 5 g/L).
  • Urine M-protein >= 200 mg/24 hours.
  • In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
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  • Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
  • -- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
  • Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

Who cannot join

  • Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
  • Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
  • Central nervous system involvement of MM.
  • Has received B-cell maturation antigen (BCMA)-targeted therapy.

Trial locations and contacts

166 sites in 25 countries.

166 sites in 25 countries

United States46 sites

  • Regents of the University of Michigan /ID# 261577

    Ann Arbor, Michigan, 48109-1276

  • Winship Cancer Institute of Emory University /ID# 262525

    Atlanta, Georgia, 30322

  • Our Lady Of The Lake Regional Medical Center /ID# 272780

    Baton Rouge, Louisiana, 70808

  • New York Cancer & Blood Specialists - Bay Shore /ID# 261524

    Bay Shore, New York, 11706

  • Alta Bates Summit Medical Center for Research /ID# 261438

    Berkeley, California, 94705

  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637

    Bethesda, Maryland, 20817

  • University of Alabama at Birmingham - Main /ID# 261434

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center /ID# 271535

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute /ID# 261554

    Boston, Massachusetts, 02215

  • University of North Carolina /ID# 259854

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina /ID# 259692

    Charleston, South Carolina, 29425

  • Atrium Health Levine Cancer Institute /ID# 246199

    Charlotte, North Carolina, 28204

  • University of Illinois Hospital and Health Sciences System /ID# 246349

    Chicago, Illinois, 60607

  • Rush University Medical Center /ID# 265690

    Chicago, Illinois, 60612

  • University Of Cincinnati Medical Center /ID# 246415

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Main Campus /ID# 246183

    Cleveland, Ohio, 44195

  • University of Missouri Hospital /ID# 261553

    Columbia, Missouri, 65212

  • Karmanos Cancer Institute - Detroit /ID# 266298

    Detroit, Michigan, 48201

  • Henry Ford Hospital /ID# 262704

    Detroit, Michigan, 48202

  • Duke University Medical Center /ID# 259694

    Durham, North Carolina, 27710

  • Nancy W. Knowles Cancer Center /ID# 271361

    Elmhurst, Illinois, 60126

  • Virginia Cancer Specialists - Fairfax /ID# 262792

    Fairfax, Virginia, 22031

  • Providence - St. Jude Medical Center /ID# 262031

    Fullerton, California, 92835

  • Oncology Consultants /ID# 276774

    Houston, Texas, 77030

  • Mayo Clinic Hospital Jacksonville /ID# 263324

    Jacksonville, Florida, 32224

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230

    Jacksonville, Florida, 32256

  • Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891

    Lansing, Michigan, 48912

  • VA Loma Linda Healthcare System /ID# 261015

    Loma Linda, California, 92357

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 278320

    Lone Tree, Colorado, 80124

  • Cedars-Sinai Medical Center /ID# 261008

    Los Angeles, California, 90048

  • University of Tennessee Health Science Center /ID# 261622

    Memphis, Tennessee, 38103

  • Baptist Memorial Hospital /ID# 270910

    Memphis, Tennessee, 38120

  • The West Clinic /ID# 262444

    Memphis, Tennessee, 38120

  • Vanderbilt University Medical Center /ID# 261621

    Nashville, Tennessee, 37232-0011

  • New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953

    New Hyde Park, New York, 11042

  • New York Cancer and Blood Specialists - New York /ID# 262951

    New York, New York, 10028

  • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772

    Omaha, Nebraska, 68130

  • Mayo Clinic Hospital - Phoenix /ID# 263326

    Phoenix, Arizona, 85054

  • Oregon Medical Research Center /ID# 262335

    Portland, Oregon, 97239

  • VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944

    Richmond, Virginia, 23298

  • Mayo Clinic - Rochester /ID# 246228

    Rochester, Minnesota, 55905-0001

  • Springfield Clinic - First /ID# 262266

    Springfield, Illinois, 62702

  • Northwest Medical Specialties Tacoma /ID# 276281

    Tacoma, Washington, 98405

  • Eastchester Center for Cancer Care /ID# 262952

    The Bronx, New York, 10469

  • Texas Oncology - Northeast Texas /ID# 278304

    Tyler, Texas, 75702

Other trials in United States

China18 sites

  • Beijing Chaoyang Hospital,Capital Medical University /ID# 245533

    Beijing, Beijing Municipality, 100020

  • Peking Union Medical College Hospital East - Dongdan Campus /ID# 245545

    Beijing, Beijing Municipality, 100730

  • Fujian Medical University Union Hospital /ID# 245558

    Fuzhou, Fujian, 350001

  • Sun Yat-Sen University Cancer Center /ID# 245542

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882

    Hangzhou, Zhejiang, 310020

  • The First Affiliated Hospital of Nanchang University /ID# 245537

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University /ID# 245563

    Nanjing, Jiangsu, 210009

  • Shanghai Tongji Hospital /ID# 245539

    Shanghai, Shanghai Municipality, 200065

  • First Affiliated Hospital of China Medical University /ID# 245547

    Shenyang, Liaoning, 110001

  • The First Affiliated Hospital of Soochow University /ID# 245544

    Suzhou, Jiangsu, 215006

  • Institute of Hematology and Blood Diseases Hospital /ID# 265702

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University General Hospital /ID# 260851

    Tianjin, Tianjin Municipality, 300052

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 245550

    Wenzhou, Zhejiang, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549

    Wuhan, Hubei, 430022

  • Second Affiliated Hospital of Xian Jiaotong University /ID# 261255

    Xi'an, Shaanxi, 710004

  • People's Hospital of Henan Province /ID# 260918

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital /ID# 245536

    Zhengzhou, Henan, 450008

Other trials in China

Japan17 sites

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 265696

    Amagasaki, Hyōgo, 660-8550

  • Anjo Kosei Hospital /ID# 263434

    Anjo, Aichi-ken, 446-8602

  • Tokyo Metropolitan Komagome Hospital /ID# 277567

    Bunkyo Ku, Tokyo, 113-8677

  • Chiba University Hospital /ID# 262006

    Chiba, Chiba, 260-8677

  • University of Yamanashi Hospital /ID# 262912

    Chuo-shi, Yamanashi, 409-3898

  • Kyushu University Hospital /ID# 264704

    Fukuoka, Fukuoka, 812-8582

  • Chugoku Central Hospital /ID# 263431

    Fukuyama, Hiroshima, 720-0001

  • Gifu Municipal Hospital /ID# 263321

    Gifu, Gifu, 500-8323

  • Saitama Prefectural Cancer Center /ID# 262586

    Kitaadachi-gun, Saitama, 362-0806

  • University Hospital Kyoto Prefectural University of Medicine /ID# 262585

    Kyoto, Kyoto, 602-8566

  • Gunma University Hospital /ID# 262580

    Maebashi, Gunma, 371-8511

  • Nagoya City University Hospital /ID# 263320

    Nagoya, Aichi-ken, 467-8602

  • Naha City Hospital /ID# 263972

    Naha, Okinawa, 902-0061

  • Miyagi Cancer Center /ID# 265094

    Natori-shi, Miyagi, 981-1293

  • Japanese Red Cross Medical Center /ID# 261717

    Shibuya-ku, Tokyo, 150-8935

  • The University of Osaka Hospital /ID# 263974

    Suita-shi, Osaka, 565-0871

  • University of Fukui Hospital /ID# 264222

    Yoshida-gun, Fukui, 910-1104

Other trials in Japan

Australia7 sites

  • Monash Health - Monash Medical Centre - Clayton /ID# 262158

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne /ID# 261808

    Fitzroy Melbourne, Victoria, 3065

  • St George Hospital - Kogarah /ID# 261806

    Kogarah, New South Wales, 2217

  • Liverpool Hospital /ID# 262159

    Liverpool, New South Wales, 2170

  • Box Hill Hospital /ID# 262784

    Melbourne, Victoria, 3128

  • Calvary Mater Newcastle /ID# 261804

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital - Woolloongabba /ID# 261810

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom7 sites

  • Addenbrookes Hospital /ID# 261104

    Cambridge, Cambridgeshire, CB2 2QQ

  • Western General Hospital /ID# 261106

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Leeds Teaching Hospitals NHS Trust /ID# 261101

    Leeds, West Yorkshire, LS9 7TF

  • Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488

    London, Greater London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust /ID# 262470

    London, SW3 6JJ

  • The Christie Hospital /ID# 261102

    Manchester, M20 4BX

  • Nottingham City Hospital /ID# 261105

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Germany6 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689

    Berlin, 12203

  • Klinikum Chemnitz - Flemmingstrabe /ID# 273108

    Chemnitz, Saxony, 09116

  • Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982

    Frankfurt am Main, 60389

  • Universitaetsklinikum Freiburg /ID# 262147

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260651

    Hamburg, 20246

  • Staedtisches Klinikum Karlsruhe /ID# 272377

    Karlsruhe, Baden-Wurttemberg, 76133

Other trials in Germany

Spain6 sites

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398

    Badalona, Barcelona, 08916

  • Hospital de Leon /ID# 261624

    León, 24071

  • Hospital General Universitario Gregorio Maranon /ID# 246401

    Madrid, 28007

  • Complejo Hospitalario Universitario Ourense /ID# 246400

    Ourense, Ourense, 32005

  • Hospital Universitario de Salamanca /ID# 262218

    Salamanca, 37711

  • Hospital Universitario y Politecnico La Fe /ID# 261625

    Valencia, 46026

Other trials in Spain

Italy5 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 256812

    Ancona, 60126

  • AOU Policlinico G. Rodolico - San Marco /ID# 256814

    Catania, 95123

  • ASST Ovest Milanese /ID# 256813

    Legnano, Milano, 20025

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810

    Rome, Roma, 00161

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808

    Turin, Piedmont, 10126

Other trials in Italy

South Korea5 sites

  • Seoul National University Hospital /ID# 245491

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 245492

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493

    Seoul, Seoul Teugbyeolsi, 06591

  • Yonsei University Health System Severance Hospital /ID# 245489

    Seoul, 03722

  • Ulsan University Hospital /ID# 245490

    Ulsan, Ulsan Gwang Yeogsi, 44033

Other trials in South Korea

Austria4 sites

  • Medizinische Universitaet Graz /ID# 261908

    Graz, Styria, 8010

  • Universitaetsklinikum Krems /ID# 261509

    Krems, Lower Austria, 3500

  • Ordensklinikum Linz Elisabethinen /ID# 245609

    Linz, Upper Austria, 4010

  • Klinik Ottakring /ID# 245829

    Vienna, State of Vienna, 1160

Other trials in Austria

Czechia4 sites

  • Fakultni Nemocnice Brno - Jihlavska /ID# 245689

    Brno, Brno-mesto, 625 00

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 245690

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava /ID# 245686

    Ostrava, Ostrava-mesto, 708 52

  • Vseobecna Fakultni nemocnice v Praze /ID# 245691

    Prague, Praha 17, 128 00

Other trials in Czechia

France4 sites

  • CH Henri Duffaut /ID# 261844

    Avignon, Vaucluse, 84902

  • Centre Hospitalier du Mans /ID# 261852

    Le Mans, Sarthe, 72037

  • Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 261854

    Orléans, Loiret, 45067

  • CH Saint-Quentin /ID# 261856

    Saint-Quentin, Aisne, 02321

Other trials in France

Greece4 sites

  • Alexandra General Hospital /ID# 240591

    Athens, Attica, 11528

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596

    Athens, 10676

  • University General Hospital Attikon /ID# 240592

    Chaïdári, Attica, 12462

  • General University Hospital of Thessaloniki AXEPA /ID# 240595

    Thessaloniki, 54636

Other trials in Greece

Israel4 sites

  • Shaare Zedek Medical Center /ID# 245681

    Jerusalem, Jerusalem, 91031

  • Rabin Medical Center. /ID# 245498

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 245497

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 245495

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)4 sites

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672

    Ankara, 06200

  • Antalya Egitim Ve Arastirma Hastanesi /ID# 261674

    Antalya, 07100

  • Trakya University Medical Facu /ID# 261673

    Edirne, Istanbul, 22030

  • Istanbul Florence Nightingale Hospital /ID# 271543

    Şişli, Istanbul, 34381

Other trials in Turkey (Türkiye)

Hungary3 sites

  • Semmelweis Egyetem /ID# 261646

    Budapest, 1085

  • Semmelweis Egyetem /ID# 261647

    Budapest, 1085

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648

    Győr, Győr-Moson-Sopron, 9024

Other trials in Hungary

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne /ID# 260169

    Gdansk, Pomeranian Voivodeship, 80-214

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168

    Lublin, Lublin Voivodeship, 20-081

  • Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

Portugal3 sites

  • Fundacao Champalimaud /ID# 246258

    Lisbon, Lisbon District, 1400-038

  • Unidade Local de Saude de Santa Maria /ID# 246255

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 246257

    Porto, 4200-072

Other trials in Portugal

South Africa3 sites

  • Constantiaberg Haematology /ID# 261320

    Cape Town, Western Cape, 7800

  • Haemalife Inc. /ID# 245724

    Kuils River, Western Cape, 7580

  • Alberts Cellular Therapy /ID# 245725

    Pretoria, Gauteng, 0044

Other trials in South Africa

Sweden3 sites

  • Falu Lasarett /ID# 262231

    Falun, 791 82

  • Helsingborgs Lasarett /ID# 262513

    Helsingborg, Skåne County, 251 87

  • Uddevalla sjukhus /ID# 262034

    Uddevalla, Västra Götaland County, 451 80

Other trials in Sweden

Taiwan3 sites

  • China Medical University Hospital /ID# 245483

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 261142

    Taichung, 40705

  • National Taiwan University Hospital /ID# 245482

    Taipei, 100

Other trials in Taiwan

Belgium2 sites

  • Algemeen Ziekenhuis klina /ID# 260856

    Brasschaat, Antwerpen, 2930

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 245345

    Bruges, West-Vlaanderen, 8000

Other trials in Belgium

Denmark2 sites

  • Odense University Hospital /ID# 260924

    Odense, Region Syddanmark, 5000

  • Vejle Sygehus /ID# 260923

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Puerto Rico2 sites

  • Hematology And Oncology Institute /ID# 272531

    Manati, 00674

  • Auxilio Mutuo Cancer Center /ID# 272565

    San Juan, 00918

Other trials in Puerto Rico

Canada1 site

  • University Health Network_Princess Margaret Cancer Centre /ID# 261566

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.

Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.

Read more

In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Being tested
Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor
Keywords
Cervino, Multiple Myeloma, Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor, Bortezomib, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • EtentamigDrug

    Also called ABBV-383

    Intravenous (IV) Infusion

  • CarfilzomibDrug

    IV Infusion

  • PomalidomideDrug

    Oral Capsule

  • ElotuzumabDrug

    IV Infusion

  • SelinexorDrug

    Oral Tablet

  • BortezomibDrug

    Subcutaneous or IV Injection

  • DexamethasoneDrug

    Oral Tablet or IV Infusion

Study groups in NCT06158841
Study groupRoleWhat they receive
EtentamigExperimentalParticipants will receive etentamig as a monotherapy.
Receives: Drug: Etentamig
Standard Available Therapy (SAT)ExperimentalParticipants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
Receives: Drug: Carfilzomib; Drug: Pomalidomide; Drug: Elotuzumab; Drug: Selinexor; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.

    Measured: Up to Approximately 5 Years

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.

    Measured: Up to Approximately 5 Years

Secondary outcomes (19)

  1. Overall Survival (OS)

    OS is defined as the duration from the date of randomization to the date of the participant's death.

    Measured: Up to Approximately 5 Years

  2. Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)

    The rate of >= VGPR is defined as the proportion of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new myeloma therapy.

    Measured: Up to Approximately 5 Years

  3. Change in Rate of CR or Better (>=CR)

    >=CR is defined as the percentage of participants who achieve confirmed CR + sCR or per IRC assessment.

    Measured: Up to Approximately 5 Years

  4. Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR

    MRD negativity with >= CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by next-generation sequencing (NGS) Adaptive Clonoseq at 10^-5 threshold.

    Measured: Up to Approximately 5 Years

  5. Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)

    The disease symptoms domain of EORTC QLQ-MY20 is a 6-item questionnaire to assess the physical function of the participant, with a higher score indicating a higher level of symptoms.

    Measured: Up to 6 Months

  6. Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

    The physical functioning domain of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indicating worse functioning.

    Measured: Up to 6 Months

  7. Time to Response (TTR)

    TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by IRC.

    Measured: Up to Approximately 5 Years

  8. Duration of Response (DOR)

    DOR is defined as the number of days from the day the response criteria are met to the date that disease progression as determined by the IRC.

    Measured: Up to Approximately 5 Years

  9. Time-to-Progression (TTP)

    TTP is defined as the number of days from the date of first dose to the date of earliest disease progression as determined by the IRC.

    Measured: Up to Approximately 5 Years

  10. Time to Next Anti-lymphoma Therapy (TTNT)

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to Approximately 5 Years

  11. Number of Participants with Event-free Survival (EFS)

    EFS is defined as the time from randomization until adverse event determined by the IRC, or death, whichever occurs first.

    Measured: Up to Approximately 5 Years

  12. Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)

    The PROMIS Fatigue SF7a is a 7-item short form that assesses the impact and experience of fatigue in the past 7 days. For each item, 5-point rating scales are used to measure frequency ("Never," "Rarely," "Sometimes," "Often," or "Always") with a higher score indicating a greater impact.

    Measured: Up to Approximately 6 Months

  13. Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items are scored from 0 to 4 to evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

    Measured: Up to Approximately 6 Months

  14. Change from Baseline in Remaining Items in the EORTC QLQ-C30

    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

    Measured: Up to Approximately 6 Months

  15. Change from Baseline in Remaining Items in the EORTC QLQ-MY20

    The EORTC QLQ-MY20 consists of four scales: two symptom scales (Disease Symptoms [6 items] and Side Effects of Treatment [10 items]), one function scale (Future Perspective [3 items]), and one single item (Body Image). Each item has four response options: "Not at all," "A little," "Quite a bit," or "Very much". All scores are then linearly transformed to a 0 to 100 scale. A higher score on the symptom scales indicates a higher level of symptoms, whereas higher scores on future perspective and body image indicate good functioning or support.

    Measured: Up to Approximately 6 Months

  16. Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

    Measured: Up to Approximately 6 Months

  17. Change from Baseline in Patient Global Impression of Severity (PGIS)

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

    Measured: Up to Approximately 6 Months

  18. Change from Baseline in Patient Global Impression of Change (PGIC)

    The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

    Measured: Up to Approximately 6 Months

  19. Number of Participants with Skeletal-Related Event (SRE)

    SREs are defined as the presence of any of the following spinal cord compression, pathologic fracture, surgery to bone, or radiation to bone.

    Measured: Up to Approximately 5 Years

Timeline

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

  1. First posted6 Dec 2023
  2. Study start19 May 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158841
Sponsor's protocol ID
M22-574
Other IDs
2023-506668-15-00, 2023
Acronym
CERVINO
Status last verified
Aug 2026
First submitted
28 Nov 2023
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etentamig, Carfilzomib and Pomalidomide in people with Multiple Myeloma, run by AbbVie at 166 sites in 25 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 9 inclusion and 4 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, China, Japan, Australia, United Kingdom and 20 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 NCT06158841.

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 27 Aug 2026.

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