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

NCT07825064 — Phase 2, Recruiting, 45 participants, Hoffmann-La Roche

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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

RegistryNCT07825064
StatusRecruiting
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment45 (Estimated)
SponsorHoffmann-La Roche (Industry)
ConditionsMultiple Myeloma
InterventionsCevostamab, Pomalidomide, Dexamethasone, Tocilizumab (Drug)
Datesstart 2026-10-30 (estimated), primary completion 2029-04-13 (estimated), completion 2031-01-19 (estimated), first posted 2026-09-17, last updated 2026-10-15
Locations2 sites in Germany

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Cevostamab All trials of Pomalidomide

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Cevostamab plus Pomalidomide and Dexamethasone (Pd)ExperimentalDrug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: TocilizumabCevostamab 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.
  • Cevostamab (Drug), also known as RO7187797: Participants will receive cevostamab as per the schedule given in the protocol.
  • Pomalidomide (Drug): Pomalidomide will be administered as per the schedule given in the protocol.
  • Dexamethasone (Drug): Dexamethasone will be administered as a premedication as per the schedule given in the protocol.
  • Tocilizumab (Drug), also known as Actemra/RoActemra: Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

+Outcome measures

Primary outcomes

  • Overall Response Rate (ORR) as assessed by an Independent Review Committee [Up to approximately 3 years]

Secondary outcomes

  • ORR, as assessed by the Investigator [Up to approximately 3 years]
  • Rate of Very Good Partial Response (VGPR) or Better [Up to approximately 3 years]
  • Complete Response/Stringent Complete Response (CR/sCR) Rate [Up to approximately 3 years]
  • Duration of Response (DOR) [Up to approximately 3 years]
  • Progression-free Survival (PFS) [Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)]
  • Overall Survival (OS) [Baseline up until death from any cause (up to approximately 3 years)]
  • MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS) [At 9 months]
  • Overall MRD-Negative Complete Response Rate [Up to approximately 3 years]
  • Time to Response (TTR) [Baseline up to approximately 3 years]
  • Time to Better Response (TTBR) [Baseline up to approximately 3 years]
  • Progression-Free Survival 2 (PFS2) [Up to approximately 3 years]
  • Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20 [Up to approximately 3 years]
  • Time to Confirmed Deterioration in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30) [Up to approximately 3 years]
  • Incidence and Severity of Adverse Events (AEs) [Up to approximately 3 years]
  • Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20 [Baseline and up to 3 years]
  • Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30) [Baseline and up to 3 years]
  • Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30 [Baseline and up to 3 years]
  • Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30 [Up to approximately 3 years]
  • Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20 [Up to approximately 3 years]
  • Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30 [Up to approximately 3 years]
  • Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30 [Up to approximately 3 years]
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline [Baseline]
  • Percentage of Participants with ADAs to Cevostamab during the Study [Up to approximately 3 years]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

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/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.

+Locations (2)

FacilityCityCountryStatus
Universitätsmedizin GreifswaldGreifswaldGermanyRecruiting
Universitätsklinikum Jena, Klinik für Innere Medizin IIJenaGermanyRecruiting

+Investigators

  • Clinical Trials, Study director, Hoffmann-La Roche