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

Phase 3RecruitingNCT07555938

Hoffmann-La Roche380 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

380

Conditions

Multiple Myeloma

Interventions

CevostamabDRUG

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

PomalidomideDRUG

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

DexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (75)

Outcomes

Primary Outcomes

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 Outcomes

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)

Primary domains: fatigue, pain, physical functioning, cognitive functioning and global health status.

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

Central 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

ElotuzumabDRUG

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

CarfilzomibDRUG

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

City of Hope National Medical Center

Duarte, California, United States

RECRUITING

City of Hope - Lennar Foundation Cancer Center

Irvine, California, United States

RECRUITING

Yale University

New Haven, Connecticut, United States

RECRUITING

MedStar Washington Hospital Center MedStar Georgetown Cancer Institute

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

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

RECRUITING

Novant Health Cancer Institute

Charlotte, North Carolina, United States

RECRUITING

Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

RECRUITING

TriHealth Cancer and Blood Institute

Cincinnati, Ohio, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, United States

RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

RECRUITING

...and 65 more locations

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