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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Tocilizumab; Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Germany
  • Jena, Germany, 07747
    • Recruiting
    • Universitätsklinikum Jena, Klinik für Innere Medizin II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: Tocilizumab; Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.; Other Names: Actemra/RoActemra; Drug: Cevostamab; Participants will receive cevostamab as per the schedule given in the protocol.; Other Names: RO7187797; Drug: Pomalidomide; Pomalidomide will be administered as per the schedule given in the protocol.; Drug: Dexamethasone; Dexamethasone will be administered as a premedication as per the schedule given in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate (ORR) as assessed by an Independent Review Committee	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Response (DOR)	Up to approximately 3 years
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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 13, 2029
• Study Completion (Estimated): January 30, 2031

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; tocilizumab; pomalidomide
• Other Study ID Numbers: CO46577; 2026-525736-42-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes