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

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07555938
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Participants will receive cevostamab IV as per the schedule given in the protocol.
  • Pomalidomide — DRUG
    Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
  • Dexamethasone — DRUG
    Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
  • Daratumumab — DRUG
    Participants will receive daratumumab SC as per the schedule given in the protocol.
  • Elotuzumab — DRUG
    Participants will receive elotuzumab IV as per the schedule given in the protocol.
  • Carfilzomib — DRUG
    Participants will receive carfilzomib IV as per the schedule given in the protocol.

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Jan 31, 2033

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate [ Time Frame: Up to 1 year after the last participant is randomized ]

Central Contacts

  • Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-3012-
City of Hope - Lennar Foundation Cancer CenterIrvineCalifornia92618-
Emory University Hospital MidtownAtlantaGeorgia30308-
Novant Health Cancer InstituteCharlotteNorth Carolina28204-
Forsythe Memorial Hospital Inc., dba Novant Health Oncology SpecialistsWinston-SalemNorth Carolina27103-
TriHealth Cancer and Blood InstituteCincinnatiOhio45220-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Lennar Foundation Cancer Center· Irvine, CAEmory University Hospital Midtown· Atlanta, GANovant Health Cancer Institute· Charlotte, NCForsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists· Winston-Salem, NCTriHealth Cancer and Blood Institute· Cincinnati, OH

Related Studies