Cevostamab with pomalidomide and dexamethasone vs standard care in previously treated multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial comparing a cevostamab-based regimen (CevosPd) to standard of care in adults with multiple myeloma after 1–3 prior lines of therapy and prior exposure to anti-CD38 therapy and lenalidomide. Participants receive cevostamab with pomalidomide and dexamethasone, versus SOC, to assess efficacy and safety. Eligibility includes measurable disease, ECOG 0–1 (or 2 from myeloma-related symptoms), and adequate organ function. Key exclusions include systemic light chain amyloidosis with organ involvement, plasma cell leukemia, and significant GI absorption issues.

Why it matters

Who can join: the full rules

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 systemic light chain amyloidosis with major organ involvement (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
* Known history or current plasma cell leukemia
* GI disease that might significantly alter absorption of oral drugs
* Participants must not have any ongoing CNS disease or non-secretory myeloma

Where it's running

• 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
• University of Illinois
  Chicago, Illinois, United States Recruiting

+53 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

• Cevostamab in relapsed or refractory multiple myeloma

  This early-stage trial tests cevostamab alone or with standard therapies to see if it is safe and how it behaves in people with relapsed or refractory multiple myeloma.

  Recruiting at 4 sites Phase 1 Genentech, Inc. · Duarte, California and 33 other locations · NCT04910568

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.