Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT03275103
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cevostamab — DRUG
    Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
  • Tocilizumab — DRUG
    Tocilizumab will be administered as premedication during Cycle 1.

Study Details

This is a phase I, multicenter, open-label, dose-escalation study of cevostamab administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).

Key Dates

Start date
Sep 19, 2017
Status verified
Feb 2026
Primary completion
Jan 7, 2026
Completion
Jan 7, 2026

Study Design

Enrollment
355 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Single Step Dose Escalation for Cevostamab
    Study drug will be administered intravenously on a 21-day cycle. The step-up dose will be given on Cycle 1 Day 1 and the target dose will be given on C1D8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
  • Experimental: Arm B: Double Step Dose Escalation for Cevostamab
    In Cycle 1, participants will receive 2 step-up doses and a target dose. The step-up dose will be given on Cycle 1 Day 1 and C1D8. The target dose will be given on C1D15. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
  • Experimental: Arm C: Single Step Dose Expansion for Cevostamab
    The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
  • Experimental: Arm D: Double Step Dose Expansion for Cevostamab
    The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
  • Experimental: Arm E: Expansion Phase for Tocilizumab Pretreatment
    All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
  • Experimental: Arm F: Single Step Dose Expansion for Cevostamab
    The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
  • Experimental: Arm G: Double Step Dose Expansion for Cevostamab
    The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
  • Experimental: Arm H: Triple Step Dose Escalation for Cevostamab
    In Cycle 1, participants will receive 3 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 2-4, 8, and 9-11. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
  • Experimental: Arm I: Triple Step Dose Expansion for Cevostamab
    The triple step dose expansion stage of the study may use the dosing and assessment schedule from the triple step dose escalation arm in Cycle 1, based on data from Arm H.
  • Experimental: Arm J: Expansion Phase for Tocilizumab Pretreatment
    All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
  • Experimental: Arm K: Compressed Double Step Dose Expansion for Cevostamab
    In Cycle 1, participants will receive 2 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 4, and 8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 8 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Mayo Clinic Hospital - ArizonaScottsdaleArizona85259-
City of HopeDuarteCalifornia91010-
University of Colorado DenverAuroraColorado80045-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan KetteringNew YorkNew York10065-
Mount Sinai HospitalNew YorkNew York10128-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic Hospital - Arizona· Scottsdale, AZCity of Hope· Duarte, CAUniversity of Colorado Denver· Aurora, CODana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering· New York, NY

Related Studies