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NCT Number: NCT07555938

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya City University Hospital, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cevostamab

Drug

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

Pomalidomide

Drug

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

Dexamethasone

Drug

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

Daratumumab

Drug

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

Elotuzumab

Drug

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

Carfilzomib

Drug

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

Primary outcomes

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

    Time frame: Up to 1 year after the last participant is randomized

  2. Progression-Free Survival (PFS)

    Time frame: Up to 5 years after the last participant is randomized

Secondary outcomes

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

    Time frame: Up to 5 years after the last participant is randomized

  2. Overall Survival (OS)

    Time frame: 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)

    Time frame: Up to 5 years after the last participant is randomized

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

  4. Overall Response Rate (ORR)

    Time frame: Up to 5 years after the last participant is randomized

  5. Complete Response (CR) Rate

    Time frame: Up to 5 years after the last participant is randomized

  6. Time to Response (TTR)

    Time frame: Up to 5 years after the last participant is randomized

  7. Time to Best Response (TTBR)

    Time frame: Up to 5 years after the last participant is randomized

  8. Duration of Response (DOR)

    Time frame: Up to 5 years after the last participant is randomized

  9. Progression-Free Survival (PFS)

    Time frame: Up to 5 years after the last participant is randomized

  10. Progression-Free Survival 2 (PFS2)

    Time frame: Up to 5 years after the last participant is randomized

  11. Overall MRD-Negative Complete Response Rate

    Time frame: Up to 5 years after the last participant is randomized

  12. Overall MRD-Negative Rate

    Time frame: Up to 5 years after the last participant is randomized

  13. Sustained MRD-Negative CR Rate

    Time frame: At 6, 12, and 24 months

  14. Percentage of Participants With Adverse Events (AEs)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: Up to 5 years after the last participant is randomized

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: CEVOLUTION

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Apr 29, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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