A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Part of paid clinical trials in La Jolla, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05137054
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Linvoseltamab — DRUG
    Linvoseltamab is administered by intravenous (IV) infusion
  • Daratumumab — DRUG
    Daratumumab is administered by IV infusion and/or subcutaneous (SC) injection; SC injection may be used after a minimum of 2 cycles of IV administration at the investigator's discretion.
  • Carfilzomib — DRUG
    Carfilzomib is administered by IV infusion
  • Lenalidomide — DRUG
    Lenalidomide is administered by mouth (PO) as a capsule
  • Bortezomib — DRUG
    Bortezomib is administered by IV infusion or SC injection
  • Pomalidomide — DRUG
    Pomalidomide is administered by mouth (PO) as a capsule
  • Isatuximab — DRUG
    Isatuximab is administered by IV infusion
  • Fianlimab — DRUG
    Fianlimab is administered by IV infusion
  • Cemiplimab — DRUG
    Cemiplimab is administered by IV infusion
  • Nirogacestat — DRUG
    Nirogacestat is administered by mouth (PO) as a tablet
  • Cevostamab — DRUG
    Cevostamab is administered by IV infusion

Study Details

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Key Dates

Start date
Aug 17, 2022
Status verified
May 2025
Primary completion
Apr 11, 2028
Completion
Sep 26, 2034

Study Design

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

Arms

  • Experimental: Cohort 1: Linvoseltamab + Daratumumab
    Linvoseltamab + Daratumumab
  • Experimental: Cohort 2: Linvolseltamab + Carfilzomib
    Linvoseltamab + Carfilzomib
  • Experimental: Cohort 3: Linvoseltamab + Lenalidomide
    Linvoseltamab + Lenalidomide
  • Experimental: Cohort 4: Linvoseltamab + Bortezomib
    Linvoseltamab + Bortezomib
  • Experimental: Cohort 5: Linvoseltamab + Pomalidomide
    Linvoseltamab + Pomalidomide
  • Experimental: Cohort 6: Linvoseltamab + Isatuximab
    Linvoseltamab + Isatuximab
  • Experimental: Cohort 7: Linvoseltamab + Fianlimab
    Linvoseltamab + Fianlimab
  • Experimental: Cohort 8: Linvoseltamab + Cemiplimab
    Linvoseltamab + Cemiplimab
  • Experimental: Cohort 9: Linvoseltamab + Nirogacestat
    Linvoseltamab + Nirogacestat
  • Experimental: Cohort 10: Linvoseltamab + Cevostamab
    Linvoseltamab + Cevostamab

Primary Outcome Measure

Incidence of pre-defined safety criteria or 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 (13)

FacilityCityStateZIPSite coordinators
Scripps Clinic Torrey PinesLa JollaCalifornia92037-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30004-
Indiana University Health Simon Cancer CenterIndianapolisIndiana46202-
Dana Farber/Harvard Cancer CenterBostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
Mayo ClinicRochesterMinnesota55905-
New York Presbyterian Hospital Columbia University Medical CenterNew YorkNew York10032-
Weill Cornell Medicine/New York Presbyterian HospitalNew YorkNew York10021-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
The Ohio State University James Cancer HospitalColumbusOhio43210-
University of Texas SouthwesternDallasTexas75390-
VA Puget Sound Health Care SystemSeattleWashington98108-

Find similar trials in La Jolla, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Scripps Clinic Torrey Pines· La Jolla, CAWinship Cancer Institute of Emory University· Atlanta, GAIndiana University Health Simon Cancer Center· Indianapolis, INDana Farber/Harvard Cancer Center· Boston, MAKarmanos Cancer Institute· Detroit, MIMayo Clinic· Rochester, MN

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