ClinicalTrials.gg
RecruitingNCT07825064Updated Nov 5, 2026

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

A Phase 2 interventional study of Cevostamab and Pomalidomide in Multiple Myeloma, sponsored by Hoffmann-La Roche. Recruiting at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Start date movedStudy completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 45 is close to the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment.
  • Received one to four , 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 during screening

Exclusion criteria

Exclusion Criteria:

  • Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue 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 to any of the 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Cevostamab plus Pomalidomide and Dexamethasone (Pd)

    Cevostamab 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.

    Drug: Cevostamab · Drug: Pomalidomide · Drug: Dexamethasone · Drug: Tocilizumab

Interventions

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

    Also known as: RO7187797

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

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

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

    Also known as: Actemra/RoActemra

06

What researchers measure

Primary outcomes

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

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. ORR, as assessed by the Investigator

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

  4. Duration of Response (DOR)

    Time frame: Up to approximately 3 years

  5. Progression-free Survival (PFS)

    Time frame: 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)

    Time frame: 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)

    Time frame: At 9 months

  8. Overall MRD-Negative Complete Response Rate

    Time frame: Up to approximately 3 years

  9. Time to Response (TTR)

    Time frame: Baseline up to approximately 3 years

  10. Time to Better Response (TTBR)

    Time frame: Baseline up to approximately 3 years

  11. Progression-Free Survival 2 (PFS2)

    Time frame: Up to approximately 3 years

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

    Time frame: 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)

    Time frame: Up to approximately 3 years

  14. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to approximately 3 years

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

    Time frame: Baseline and up to 3 years

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

    Time frame: Baseline and up to 3 years

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

    Time frame: Baseline and up to 3 years

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

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

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

    Time frame: Baseline

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

    Time frame: Up to approximately 3 years

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2026 (actual). Primary completion is estimated for Apr 2029, 29 months after the start.

Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's planned 29 months is below that.

Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.

Start moved twice since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, last on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 17, 2026
StartActual
Nov 3, 2026was Oct 2026
Primary completionEst.
Apr 13, 2029
CompletionEst.
Jan 19, 2031
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
4 sites added
Show 4 added (4 Germany)
  • Universitätsmedizin Greifswald · Greifswald, Germany
  • Klinikum Nürnberg Nord · Nuremberg, Germany
  • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V · Heidelberg, Germany
  • UKSH, Campus Kiel · Kiel, Germany
across 2 updates, Oct 15, 2026 – Nov 5, 2026
Start date
Oct 1, 2026→Nov 3, 2026 (actual)
moved 2 times, Oct 15, 2026 – Nov 5, 2026
Study completion
Jan 30, 2031→Jan 19, 2031
Oct 15, 2026
Show all 2 updates
  1. Nov 5, 2026
    3 sites added
    Show 3 added (3 Germany)
    • Klinikum Nürnberg Nord · Nuremberg, Germany
    • UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V · Heidelberg, Germany
    • UKSH, Campus Kiel · Kiel, Germany
    Start date Oct 30, 2026→Nov 3, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 15, 2026
    1 site added
    Show site
    • Universitätsmedizin Greifswald · Greifswald, Germany
    Start date Oct 1, 2026→Oct 30, 2026
    Study completion Jan 30, 2031→Jan 19, 2031
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07825064
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Nov 3, 2026
Primary completion
Apr 13, 2029 (estimated)
Completion
Jan 19, 2031 (estimated)
Last update
Nov 5, 2026

Study contacts

Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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