Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

NCT07555938 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CO460962025-524028-23-00
• Study Type: interventional
• Target: 380
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate

  Up to 1 year after the last participant is randomized

• Progression-Free Survival (PFS)

  Up to 5 years after the last participant is randomized

Secondary Outcomes (27)

• Very Good Partial Response (VGPR) or Better Rate

  Up to 5 years after the last participant is randomized

• Overall Survival (OS)

  Up to 5 years after the last participant is randomized

• Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20)

  Up to 5 years after the last participant is randomized

• Overall Response Rate (ORR)

  Up to 5 years after the last participant is randomized

• Complete Response (CR) Rate

  Up to 5 years after the last participant is randomized

Study Arms (2)

Cevostamab + Pomalidomide + Dexamethasone

EXPERIMENTAL

Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards. Dexamethasone will be administered as a premedication prior to cevostamab.

Drug: Cevostamab; Drug: Pomalidomide; Drug: Dexamethasone

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants will receive investigator's choice of one SOC regimen.

Drug: Pomalidomide; Drug: Dexamethasone; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib

Interventions

Cevostamab DRUG

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

Cevostamab + Pomalidomide + Dexamethasone

Pomalidomide DRUG

Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.

Cevostamab + Pomalidomide + Dexamethasone; Standard of Care (SOC)

Dexamethasone DRUG

Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.

Cevostamab + Pomalidomide + Dexamethasone; Standard of Care (SOC)

Daratumumab DRUG

Participants will receive daratumumab SC as per the schedule given in the protocol.

Standard of Care (SOC)

Elotuzumab DRUG

Participants will receive elotuzumab IV as per the schedule given in the protocol.

Standard of Care (SOC)

Carfilzomib DRUG

Participants will receive carfilzomib IV as per the schedule given in the protocol.

Standard of Care (SOC)

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 start of administration of study treatment.
• Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
• MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
• Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
• 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/liter (L) or 5% of the peripheral blood white cells
• GI disease that might significantly alter absorption of oral drugs
• Participants must not have any ongoing CNS disease or non-secretory myeloma

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

City of Hope National Medical Center

Duarte, California, 91010-3012, United States

RECRUITING

City of Hope - Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Novant Health Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

Winston-Salem, North Carolina, 27103, United States

RECRUITING

TriHealth Cancer and Blood Institute

Cincinnati, Ohio, 45220, United States

RECRUITING

Nagoya City University Hospital

Aichi, 467-8602, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

Yamagata University Hospital

Yamagata, 990-9585, Japan

RECRUITING

Auxilio Mutuo Cancer Center

San Juan, 917, Puerto Rico

RECRUITING

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Seoul St Mary's Hospital

Seoul, 06591, South Korea

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; daratumumab; elotuzumab; carfilzomib

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): January 31, 2033
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (6); PR (1); JP (4); KR (4)