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Multiple MyelomaPhase 2NCT07825064

Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma

A Phase 2 study testing Cevostamab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Hoffmann-La Roche at 5 sites in Germany.

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) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody… 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
45 participants
Where
5 sitesGermany
Study dates
3 Nov 2026to 19 Jan 2031
Phase
Phase 2
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 the start of administration of study treatment.
  • Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy
  • Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line
  • 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/µL or 5% of the peripheral blood white cells
  • History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab
  • Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs
  • Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

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

5 sites in 1 country

Germany5 sites, 5 recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475

    Recruiting

  • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

    Heidelberg, 69120

    Recruiting

  • Universitätsklinikum Jena, Klinik für Innere Medizin II

    Jena, 07747

    Recruiting

  • UKSH, Campus Kiel

    Kiel, 24105

    Recruiting

  • Klinikum Nürnberg Nord

    Nuremberg, Bavaria, 90419

    Recruiting

Other trials in Germany

About this study

Official title: A Phase II, Single Arm, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone in Patients With Multiple Myeloma Who Have Received a Prior BCMA-Targeting CAR T-Cell Therapy

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.

Being tested
Cevostamab, Pomalidomide, Dexamethasone, Tocilizumab
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

    Also called RO7187797

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

  • PomalidomideDrug

    Pomalidomide will be administered as per the schedule given in the protocol.

  • DexamethasoneDrug

    Dexamethasone will be administered as a premedication as per the schedule given in the protocol.

  • TocilizumabDrug

    Also called Actemra/RoActemra

    Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Study groups in NCT07825064
Study groupRoleWhat they receive
Cevostamab plus Pomalidomide and Dexamethasone (Pd)ExperimentalCevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study. Participants will receive Cevostamab as per the schedule in the protocol.
Receives: Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Tocilizumab

What is being measured

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

  1. Overall Response Rate (ORR) as assessed by an Independent Review Committee

    Measured: Up to approximately 3 years

Secondary outcomes (23)

  1. ORR, as assessed by the Investigator

    Measured: Up to approximately 3 years

  2. Rate of Very Good Partial Response (VGPR) or Better

    Measured: Up to approximately 3 years

  3. Complete Response/Stringent Complete Response (CR/sCR) Rate

    Measured: Up to approximately 3 years

  4. Duration of Response (DOR)

    Measured: Up to approximately 3 years

  5. Progression-free Survival (PFS)

    Measured: Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)

  6. Overall Survival (OS)

    Measured: Baseline up until death from any cause (up to approximately 3 years)

  7. MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)

    Measured: At 9 months

  8. Overall MRD-Negative Complete Response Rate

    Measured: Up to approximately 3 years

  9. Time to Response (TTR)

    Measured: Baseline up to approximately 3 years

  10. Time to Better Response (TTBR)

    Measured: Baseline up to approximately 3 years

  11. Progression-Free Survival 2 (PFS2)

    Measured: Up to approximately 3 years

  12. Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20

    Measured: Up to approximately 3 years

  13. Time to Confirmed Deterioration in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)

    Measured: Up to approximately 3 years

  14. Incidence and Severity of Adverse Events (AEs)

    Measured: Up to approximately 3 years

  15. Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20

    Measured: Baseline and up to 3 years

  16. Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)

    Measured: Baseline and up to 3 years

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

    Measured: Baseline and up to 3 years

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

    Measured: Up to approximately 3 years

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

    Measured: Up to approximately 3 years

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

    Measured: Up to approximately 3 years

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

    Measured: Up to approximately 3 years

  22. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline

    Measured: Baseline

  23. Percentage of Participants with ADAs to Cevostamab during the Study

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted17 Sep 2026
  2. Study start3 Nov 2026
  3. Primary completion13 Apr 2029 (estimated)
  4. Study completion19 Jan 2031 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825064
Sponsor's protocol ID
CO46577
Other IDs
2026-525736-42-00
Status last verified
Nov 2026
First submitted
14 Sep 2026
Last updated
5 Nov 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 2 study testing Cevostamab, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Hoffmann-La Roche at 5 sites in Germany.

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 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: CO46577 https://forpatients.roche.com/No attachments to email below. (888-662-6728 (U.S. and Canada), 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?

Overall Response Rate (ORR) as assessed by an Independent Review Committee (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07825064.

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 5 Nov 2026.

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