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

NCT07825064 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CO465772026-525736-42-00
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 3 years

Secondary Outcomes (23)

• 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)

Study Arms (1)

Cevostamab plus Pomalidomide and Dexamethasone (Pd)

EXPERIMENTAL

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

Cevostamab DRUG

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

Also known as: RO7187797

Cevostamab plus Pomalidomide and Dexamethasone (Pd)

Pomalidomide DRUG

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

Cevostamab plus Pomalidomide and Dexamethasone (Pd)

Dexamethasone DRUG

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

Cevostamab plus Pomalidomide and Dexamethasone (Pd)

Tocilizumab DRUG

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

Also known as: Actemra/RoActemra

Cevostamab plus Pomalidomide and Dexamethasone (Pd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, 07747, Germany

RECRUITING

Related 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.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Dexamethasone; tocilizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 13, 2029
• Study Completion (Estimated): January 30, 2031
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)