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Recruiting NCT07555938

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

Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cevostamab, Pomalidomide, Dexamethasone, Daratumumab.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan, Puerto Rico, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Very Good Partial Response (VGPR) or Better Rate [Time frame: Up to 5 years after the last participant is randomized]
  • Overall Survival (OS) [Time frame: 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) [Time frame: Up to 5 years after the last participant is randomized]
  • Overall Response Rate (ORR) [Time frame: Up to 5 years after the last participant is randomized]
  • Complete Response (CR) Rate [Time frame: Up to 5 years after the last participant is randomized]
  • Time to Response (TTR) [Time frame: Up to 5 years after the last participant is randomized]
  • Time to Best Response (TTBR) [Time frame: Up to 5 years after the last participant is randomized]
  • Duration of Response (DOR) [Time frame: Up to 5 years after the last participant is randomized]
  • Progression-Free Survival (PFS) [Time frame: Up to 5 years after the last participant is randomized]
  • Progression-Free Survival 2 (PFS2) [Time frame: Up to 5 years after the last participant is randomized]
  • Overall MRD-Negative Complete Response Rate [Time frame: Up to 5 years after the last participant is randomized]
  • Overall MRD-Negative Rate [Time frame: Up to 5 years after the last participant is randomized]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • City of Hope National Medical Center — Duarte
  • City of Hope - Lennar Foundation Cancer Center — Irvine
  • Emory University Hospital Midtown — Atlanta
  • Novant Health Cancer Institute — Charlotte
  • Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists — Winston-Salem
  • TriHealth Cancer and Blood Institute — Cincinnati
Japan · 4 centers
  • Nagoya City University Hospital — Aichi
  • University Hospital Kyoto Prefectural University of Medicine — Kyoto
  • The Cancer Institute Hospital of JFCR — Tokyo
  • Yamagata University Hospital — Yamagata
South Korea · 4 centers
  • Chonnam National University Hwasun Hospital — Jeollanam-do
  • Seoul National University Hospital — Seoul
  • Asan Medical Center — Seoul
  • Seoul St Mary's Hospital — Seoul
Puerto Rico · 1 center
  • Auxilio Mutuo Cancer Center — San Juan

Identifiers

NCT: NCT07555938 · CO46096 · 2025-524028-23-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗