Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Miami, Florida.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03761108
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer

Key Dates

Start date
Jan 23, 2019
Status verified
Apr 2026
Primary completion
Mar 30, 2033
Completion
Jun 16, 2033

Study Design

Enrollment
387 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Linvoseltamab - Phase 1
    Phase 1 has two parts. Part 1, consists of linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration.
  • Experimental: Linvoseltamab - Phase 2 - Cohort 1
    Low Dose of linvoseltamab IV monotherapy.
  • Experimental: Linvoseltamab - Phase 2 - Cohort 2
    High Dose of linvoseltamab IV monotherapy.
  • Experimental: Linvoseltamab - Phase 2 - Cohort 3
    Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period [ Time Frame: Up to 28 days ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Moffitt Cancer Center - McKinley DriveTampaFlorida33612-
Emory University HospitalAtlantaGeorgia30322-
Indiana University_Michigan StreetIndianapolisIndiana46202-
Norton Cancer InstituteLouisvilleKentucky40207-
C. S. Mott_University of MichiganAnn ArborMichigan48109-
Barbara Ann Karmanos Cancer CenterDetroitMichigan48201-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Columbia University Medical CenterNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Ohio State University James Cancer HospitalColumbusOhio43210-
Oregon Health and Science University (OHSU) Marquam Hill CampusPortlandOregon97239-
University of Texas MD Anderson ClinicHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Miami, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Sylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center - McKinley Drive· Tampa, FLEmory University Hospital· Atlanta, GAIndiana University_Michigan Street· Indianapolis, INNorton Cancer Institute· Louisville, KYC. S. Mott_University of Michigan· Ann Arbor, MI

Related Studies