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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cevostamab
  • Pomalidomide
  • Dexamethasone
  • Daratumumab
  • Elotuzumab
  • Carfilzomib

Treatment groups

380 Participants
are divided into 2 treatment groups

Sponsors and collaborators