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

NCT07555938

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Multiple Myeloma

Interventions: Cevostamab, Pomalidomide, Dexamethasone, Daratumumab, Elotuzumab

Countries: United States, Japan, Puerto Rico, South Korea

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (15)
  • Duarte, California, United States
  • Irvine, California, United States
  • Atlanta, Georgia, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Aichi, Japan
  • Kyoto, Japan
  • Tokyo, Japan
  • Yamagata, Japan
  • San Juan, Puerto Rico
  • Jeollanam-do, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea