RECRUITING

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

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Conditions

Multiple MyelomaRelapsed, Refractory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Quick Facts

Study Start:2019-01-23
Study Completion:2033-06-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03761108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  2. 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
  3. 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
  4. * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either:
  5. * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria:
  6. * Phase 2 (Cohorts 1 and 2):
  7. * Phase 2 (Cohort 3):
  8. 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR
  9. 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
  10. * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trial Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, 33612
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Indiana University_Michigan Street
Indianapolis, Indiana, 46202
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
C. S. Mott_University of Michigan
Ann Arbor, Michigan, 48109-5718
United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032-3729
United States
Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
United States
Oregon Health and Science University (OHSU) Marquam Hill Campus
Portland, Oregon, 97239
United States
University of Texas MD Anderson Clinic
Houston, Texas, 77030
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-23
Study Completion Date2033-06-16

Study Record Updates

Study Start Date2019-01-23
Study Completion Date2033-06-16

Terms related to this study

Keywords Provided by Researchers

  • Relapsed, Refractory

Additional Relevant MeSH Terms

  • Multiple Myeloma