A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT05535244
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Cevostamab will be administered by IV infusion in 21-day cycles.
  • Tocilizumab — DRUG
    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Study Details

This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Key Dates

Start date
Oct 17, 2022
Status verified
May 2026
Primary completion
Feb 26, 2027
Completion
Feb 26, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T)
    Participants in Cohort A1 will be treated at the double step-up split dosing regimen.
  • Experimental: Cohort A2: Prior BCMA Bispecific
    Participants enrolled into exploratory Cohort A2 will receive the same dosing regimen as Cohort A1.
  • Experimental: Cohort B1: Prior BCMA CAR-T
    Participants enrolled in expansion Cohort B1, will be given cevostamab at the selected dosing regimen.
  • Experimental: Cohort B2: Prior BCMA Bispecific
    Expansion Cohort B2 will be opened, after the initial results from Cohort A2, at the same dose as per Cohort B1.

Primary Outcome Measure

Objective Response Rate (ORR) as Determined by the Investigator [ Time Frame: Baseline up to approximately 2 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-2517-
Mayo Clinic-JacksonvilleJacksonvilleFlorida32224-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo Clinic - RochesterRochesterMinnesota55905-
Icahn School of Medicine at Mount Sinai (ISMMS)New YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
Hunstman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Aurora, CO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Colorado· Aurora, COMayo Clinic-Jacksonville· Jacksonville, FLUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDDana Farber Cancer Institute· Boston, MAMayo Clinic - Rochester· Rochester, MNIcahn School of Medicine at Mount Sinai (ISMMS)· New York, NY

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