Recruiting
Phase 3

Cevostamab & Pomalidomide & Dexamethasone

Sponsor:

Hoffmann-La Roche

Code:

NCT07555938

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cevostamab

Pomalidomide

Dexamethasone

Daratumumab

Elotuzumab

Study Details

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

Study ID

NCT07555938

Start date

Jun 23, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2033

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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/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

Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cevostamab + Pomalidomide + Dexamethasone

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.

active comparator: Standard of Care (SOC)

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

Interventions

Cevostamab

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

Pomalidomide

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

Dexamethasone

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

Daratumumab

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

Elotuzumab

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

Carfilzomib

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

Primary outcome measure

  • Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate [ Time Frame: Up to 1 year after the last participant is randomized ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 5 years after the last participant is randomized ]

Central Contacts and Locations

Central contacts

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

888-662-6728global-roche-genentech-trials@gene.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-3012

City of Hope - Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

MedStar Washington Hospital Center MedStar Georgetown Cancer Institute

Recruiting

Washington D.C., District of Columbia, United States, 20010

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Novant Health Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

Recruiting

Winston-Salem, North Carolina, United States, 27103

TriHealth Cancer and Blood Institute

Recruiting

Cincinnati, Ohio, United States, 45220

Hamilton Health Sciences - Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-14.