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Multiple MyelomaPhase 3CEVOLUTIONNCT07555938

Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

A Phase 3 study testing Cevostamab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Hoffmann-La Roche at 93 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal… 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?
Cevostamab, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
93 sitesin 18 countries
Study dates
23 Jun 2026to 31 Jan 2033
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 Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
  • Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
  • MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
  • Participants must have measurable disease during screening

Who cannot join

  • Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
  • Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/liter (L) or 5% of the peripheral blood white cells
  • GI disease that might significantly alter absorption of oral drugs
  • Participants must not have any ongoing CNS disease or non-secretory myeloma

Trial locations and contacts

93 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

93 sites in 18 countries

China14 sites, 14 recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012

    Recruiting

  • The First Affilliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Recruiting

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • The Affiliated Hospital Of Qingdao University

    Qingdao, Shandong, 266003

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

    Recruiting

  • Tianjin Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 301636

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325035

    Recruiting

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

    Recruiting

Other trials in China

Japan13 sites, 13 recruiting

  • Nagoya City University Hospital

    Aichi, 467-8602

    Recruiting

  • Matsuyama Red Cross Hospital

    Ehime, 790-8524

    Recruiting

  • Gunma University Hospital

    Gunma, 371-8511

    Recruiting

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

    Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Recruiting

  • Iwate Medical University Hospital

    Numakunai, 028-3695

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Recruiting

  • Osaka University Hospital

    Osaka, 565-0871

    Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Saitama, 343-8555

    Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku, 150-8935

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Recruiting

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

Other trials in Japan

United States10 sites, 10 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Recruiting

  • Novant Health Cancer Institute

    Charlotte, North Carolina, 28215

    Recruiting

  • TriHealth Cancer and Blood Institute

    Cincinnati, Ohio, 45220

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010-3012

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Yale University

    New Haven, Connecticut, 06510

    Recruiting

  • MedStar Washington Hospital Center MedStar Georgetown Cancer Institute

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

Germany7 sites, 7 recruiting

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

    Recruiting

  • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

    Berlin, 10967

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

    Recruiting

  • Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin

    Düsseldorf, 40479

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

    Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475

    Recruiting

  • UKSH, Campus Kiel

    Kiel, 24105

    Recruiting

Other trials in Germany

Spain7 sites, 7 recruiting

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    Recruiting

  • Hospital Costa del Sol

    Marbella, Malaga, 29603

    Recruiting

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

    Recruiting

Other trials in Spain

Poland6 sites, 6 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

    Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie-Jakubowskiego 2;Oddzial Kliniczny Hematologii

    Krakow, Lesser Poland Voivodeship, 30-688

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569

    Recruiting

  • SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

    Szczecin, 71-252

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

    Warsaw, 02-721

    Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367

    Recruiting

Other trials in Poland

South Korea6 sites, 6 recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Seoul St Mary's Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

France5 sites, 5 recruiting

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

    Recruiting

  • CHU de Nantes - Hôtel-Dieu

    Nantes, Loire-Atlantique, 44093

    Recruiting

  • CHU Lyon - Centre Hospitalier Lyon Sud

    Pierre-Benite (Lyon), 69495

    Recruiting

  • CHU de Poitiers - La Miletrie

    Poitiers, 86021

    Recruiting

  • CHU de Toulouse -Service d'Hématologie

    Toulouse, 31100

    Recruiting

Other trials in France

Italy5 sites, 5 recruiting

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127

    Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

    Recruiting

  • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Recruiting

  • AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

    Turin, Piedmont, 10126

    Recruiting

Other trials in Italy

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus

    Haifa, 31096

    Recruiting

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112001

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5266200

    Recruiting

  • Ichilov Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Denmark3 sites, 3 recruiting

  • Aarhus Universitetshospital

    Aarhus, 8000

    Recruiting

  • Rigshospitalet

    København Ø, 2100

    Recruiting

  • Sygehus Lillebælt, Vejle;Hæmatologisk Forskningsenhed, HKFE

    Vejle, 7100

    Recruiting

Other trials in Denmark

Greece3 sites, 3 recruiting

  • Evangelismos General Hospital of Athens

    Athens, 106 76

    Recruiting

  • Alexandras General Hospital of Athens

    Athens, 11528

    Recruiting

  • Anticancer Hospital of Thessaloniki " Theagenio"

    Thessaloniki, 540 07

    Recruiting

Other trials in Greece

United Kingdom3 sites, 3 recruiting

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

    Recruiting

  • Oxford Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

  • The Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV10 0QP

    Recruiting

Other trials in United Kingdom

Australia2 sites, 2 recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Czechia2 sites, 2 recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

    Recruiting

Other trials in Czechia

Brazil1 site, 1 recruiting

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05652-000

    Recruiting

Other trials in Brazil

Canada1 site, 1 recruiting

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 1C3

    Recruiting

Other trials in Canada

Puerto Rico1 site, 1 recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 917

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

Being tested
Cevostamab, Pomalidomide, Dexamethasone, Daratumumab, Elotuzumab
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CevostamabDrug

    Participants will receive cevostamab IV as per the schedule given in the protocol.

  • PomalidomideDrug

    Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.

  • DexamethasoneDrug

    Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.

  • DaratumumabDrug

    Participants will receive daratumumab SC as per the schedule given in the protocol.

  • ElotuzumabDrug

    Participants will receive elotuzumab IV as per the schedule given in the protocol.

  • CarfilzomibDrug

    Participants will receive carfilzomib IV as per the schedule given in the protocol.

Study groups in NCT07555938
Study groupRoleWhat they receive
Cevostamab + Pomalidomide + DexamethasoneExperimentalCevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards. Dexamethasone will be administered as a premedication prior to cevostamab.
Receives: Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone
Standard of Care (SOC)Active comparatorParticipants will receive investigator's choice of one SOC regimen.
Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib

What is being measured

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

  1. Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate

    Measured: Up to 1 year after the last participant is randomized

  2. Progression-Free Survival (PFS)

    Measured: Up to 5 years after the last participant is randomized

Secondary outcomes (27)

  1. Very Good Partial Response (VGPR) or Better Rate

    Measured: Up to 5 years after the last participant is randomized

  2. Overall Survival (OS)

    Measured: Up to 5 years after the last participant is randomized

  3. Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20)

    Primary domains: fatigue, pain, physical functioning, cognitive functioning and global health status.

    Measured: Up to 5 years after the last participant is randomized

  4. Overall Response Rate (ORR)

    Measured: Up to 5 years after the last participant is randomized

  5. Complete Response (CR) Rate

    Measured: Up to 5 years after the last participant is randomized

  6. Time to Response (TTR)

    Measured: Up to 5 years after the last participant is randomized

  7. Time to Best Response (TTBR)

    Measured: Up to 5 years after the last participant is randomized

  8. Duration of Response (DOR)

    Measured: Up to 5 years after the last participant is randomized

  9. Progression-Free Survival (PFS)

    Measured: Up to 5 years after the last participant is randomized

  10. Progression-Free Survival 2 (PFS2)

    Measured: Up to 5 years after the last participant is randomized

  11. Overall MRD-Negative Complete Response Rate

    Measured: Up to 5 years after the last participant is randomized

  12. Overall MRD-Negative Rate

    Measured: Up to 5 years after the last participant is randomized

  13. Sustained MRD-Negative CR Rate

    Measured: At 6, 12, and 24 months

  14. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to 5 years after the last participant is randomized

  15. Tolerability as Assessed by the Incidence of Dose Interruptions, Dose Reductions, Dose Intensity, and Treatment Discontinuation

    Measured: Up to 5 years after the last participant is randomized

  16. Number of Participants With Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Function of Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed NCI PRO-CTCAE

    Measured: Up to 5 years after the last participant is randomized

  17. Change From Baseline in Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)

    Measured: Baseline and up to 5 years after the last participant is randomized

  18. Change From Cycle 1 Day 8 in Treatment-Related Side Effect Bother as Assessed by the Functional Assessment of Cancer Therapy-General, General Population 5 (FACTG GP5)

    Measured: At Day 8 of Cycle 1, up to 5 years after the last participant is randomized. Cycle 1 is 21 days.

  19. Change From Baseline in the Disease Symptom Scale of the EORTC QLQ-MY20

    Measured: Baseline and Up to 5 years after the last participant is randomized

  20. Change from Baseline in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)

    Measured: Baseline and Up to 5 years after the last participant is randomized

  21. Time to Confirmed Deterioration in GHS/QoL as Assessed by the EORTC QLQ-C30

    Measured: Up to 5 years after the last participant is randomized

  22. Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30

    Measured: Baseline and up to 5 years after the last participant is randomized

  23. Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30

    Measured: Up to 5 years after the last participant is randomized

  24. Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20

    Measured: Up to 5 years after the last participant is randomized

  25. Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30

    Measured: Up to 5 years after the last participant is randomized

  26. Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30

    Measured: Up to 5 years after the last participant is randomized

  27. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to Cevostamab During the Study

    Measured: Baseline and up to 5 years after the last participant is randomized

Timeline

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

  1. First posted29 Apr 2026
  2. Study start23 Jun 2026
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Jan 2033 (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
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555938
Sponsor's protocol ID
CO46096
Other IDs
2025-524028-23-00, 2025
Acronym
CEVOLUTION
Status last verified
Oct 2026
First submitted
22 Apr 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cevostamab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Hoffmann-La Roche at 93 sites in 18 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 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in China, Japan, United States, Germany, Spain and 13 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?

Contact Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate (time frame: Up to 1 year after the last participant is randomized). 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 NCT07555938.

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 13 Oct 2026.

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