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RecruitingInterventionalPhase 3

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

NCT ID: NCT07555938Sponsor: Hoffmann-La RocheLast updated: 2026-05-27

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.

Arms & interventions

  • DrugCevostamab

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

  • DrugPomalidomide

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

  • DrugDexamethasone

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

  • DrugDaratumumab

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

  • DrugElotuzumab

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

  • DrugCarfilzomib

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

Outcome measures

Primary

  • 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

  • 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

  • Sustained MRD-Negative CR Rate

    Time frame: At 6, 12, and 24 months

  • Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to 5 years after the last participant is randomized

  • Tolerability as Assessed by the Incidence of Dose Interruptions, Dose Reductions, Dose Intensity, and Treatment Discontinuation

    Time frame: Up to 5 years after the last participant is randomized

  • Number of Participants With Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Function of Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed NCI PRO-CTCAE

    Time frame: Up to 5 years after the last participant is randomized

  • Change From Baseline in Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)

    Time frame: Baseline and up to 5 years after the last participant is randomized

  • Change From Cycle 1 Day 8 in Treatment-Related Side Effect Bother as Assessed by the Functional Assessment of Cancer Therapy-General, General Population 5 (FACTG GP5)

    Time frame: At Day 8 of Cycle 1, up to 5 years after the last participant is randomized. Cycle 1 is 21 days.

  • Change From Baseline in the Disease Symptom Scale of the EORTC QLQ-MY20

    Time frame: Baseline and Up to 5 years after the last participant is randomized

  • Change from Baseline in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)

    Time frame: Baseline and Up to 5 years after the last participant is randomized

  • Time to Confirmed Deterioration in GHS/QoL as Assessed by the EORTC QLQ-C30

    Time frame: Up to 5 years after the last participant is randomized

  • Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Baseline and up to 5 years after the last participant is randomized

  • Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Up to 5 years after the last participant is randomized

  • Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20

    Time frame: Up to 5 years after the last participant is randomized

  • Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30

    Time frame: Up to 5 years after the last participant is randomized

  • Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30

    Time frame: Up to 5 years after the last participant is randomized

  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to Cevostamab During the Study

    Time frame: Baseline and up to 5 years after the last participant is randomized

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

City of Hope National Medical Center

Duarte, California, 91010-3012

Recruiting

City of Hope - Lennar Foundation Cancer Center

Irvine, California, 92618

Recruiting

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30329

Recruiting