RECRUITING

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

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

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)

Official Title

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Quick Facts

Study Start:2022-08-17
Study Completion:2034-09-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05137054

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. Participants must have measurable disease as defined in the protocol according to International Myeloma Working Group (IMWG) consensus criteria
  3. 3. Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol
  4. 4. Life expectancy of at least 6 months.
  1. 1. Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  2. 2. Participants with known MM brain lesions or meningeal involvement
  3. 3. Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter
  4. 4. History of allogeneic and autologous stem cell transplantation, as described in the protocol
  5. 5. Unless stated otherwise in a specific sub-protocol, prior treatment with a T cell-based immunotherapy directed against BCMA bispecific antibodies and bispecific T-cell engagers (BiTEs), and BCMA chimeric antigen receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded)
  6. 6. History of progressive multifocal leukoencephalopathy, neurodegenerative condition or central nervous system (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded
  7. 7. Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential
  8. 8. Cardiac ejection fraction \<40% by echocardiogram (Echo) or multigated acquisition (MUGA) scan.

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Scripps Clinic Torrey Pines
La Jolla, California, 92037
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30004
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer
Indianapolis, Indiana, 46292
United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York, 10021
United States
New York Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032
United States
UNC Hillsborough
Hillsborough, North Carolina, 27278
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
The Ohio State University and the James Cancer Center
Columbus, Ohio, 43210
United States
University of Texas Southwestern
Dallas, Texas, 753909179
United States
VA Puget Sound Health Care System
Seattle, Washington, 98108
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 Date2022-08-17
Study Completion Date2034-09-26

Study Record Updates

Study Start Date2022-08-17
Study Completion Date2034-09-26

Terms related to this study

Keywords Provided by Researchers

  • Relapsed/Refractory Multiple Myeloma (RRMM)
  • B-cell maturation antigen (BCMA)
  • Anti-CD3 monoclonal antibodies (mAbs)

Additional Relevant MeSH Terms

  • Multiple Myeloma