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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cevostamab + Pomalidomide + Dexamethasone 		Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards. Dexamethasone will be administered as a premedication prior to cevostamab.
  • Drug: Cevostamab
    Participants will receive cevostamab IV as per the schedule given in the protocol.
  • Drug: Pomalidomide
    Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
  • Drug: Dexamethasone
    Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
Active Comparator
Standard of Care (SOC) 		Participants will receive investigator's choice of one SOC regimen.
  • Drug: Pomalidomide
    Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
  • Drug: Dexamethasone
    Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
  • Drug: Daratumumab
    Participants will receive daratumumab SC as per the schedule given in the protocol.
  • Drug: Elotuzumab
    Participants will receive elotuzumab IV as per the schedule given in the protocol.
  • Drug: Carfilzomib
    Participants will receive carfilzomib IV as per the schedule given in the protocol.

Recruiting Locations

MedStar Washington Hospital Center MedStar Georgetown Cancer Institute
Washington D.C., District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.