RECRUITING

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

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Conditions

Multiple MyelomaMaintenanceTeclistamab

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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

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Official Title

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation - MajesTEC-4

Quick Facts

Study Start:2022-09-08
Study Completion:2032-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05243797

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. * Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
  2. * Must have received only one line of therapy and achieved at least a partial response (≥PR) as per IMWG 2016 response criteria (Kumar 2016) without evidence of progression at the time of first treatment dose.
  3. * Must not be intolerant to the starting dose of lenalidomide.
  4. * Must not have received any maintenance therapy.
  5. * Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
  6. * Have clinical laboratory values within prespecified range.
  1. * Received any prior BCMA-directed therapy.
  2. * Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
  3. * Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
  4. * Progressed on multiple myeloma therapy at any time prior to screening.
  5. * Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
  6. * Received a live, attenuated vaccine within 4 weeks before first treatment dose. Non-live vaccines or non-replicating authorized for emergency use (eg. COVID-19) are allowed.

Contacts and Locations

Study Contact

Sabrin Tahri
CONTACT
+31 10 268 70 65
sabrin.tahri@emn.org
Sarah Lonergan
CONTACT
+31 10 268 70 65
sarah.lonergan@emn.org

Principal Investigator

Niels van de Donk, Professor
PRINCIPAL_INVESTIGATOR
Amsterdam UMC, Vrije Universiteit Amsterdam
Elena Zamagni, Professor
PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"

Study Locations (Sites)

The University of Arizona Cancer Center
Phoenix, Arizona, 85004
United States
University of California-Davis Cancer Center
Sacramento, California, 95817
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Yale New Haven Hospital
New Haven, Connecticut, 06519
United States
Blood & Marrow Transplant Center, Florida Hospital Medical Group
Orlando, Florida, 32804
United States
Moffitt at Memorial Healthcare System
Tampa, Florida, 33612
United States
University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612
United States
IU Health Blood and Bone Marrow Stem Cell Transplant and Immune Cell Therapy Program
Indianapolis, Indiana, 46202
United States
Greenebaum Cancer Center UM of MD
Baltimore, Maryland, 21201
United States
John Hopkins
Baltimore, Maryland, 21218
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States
New York Oncology Hematology (NYOH)
Albany, New York, 12208
United States
Mount Sinai Medical Center - 2
New York, New York, 10029
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
East Carolina University
Greenville, North Carolina, 27858
United States
University of Cincinnati
Cincinnati, Ohio, 45221
United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45242
United States
Seidman Cancer Center-University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, 43210
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
Abramson Cancer Center University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Gibbs Cancer Center
Spartanburg, South Carolina, 29303
United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
United States
Vanderbilt University
Nashville, Tennessee, 37240
United States
Texas Oncology
Austin, Texas, 78745
United States
Renovatio Clinical Research
El Paso, Texas, 77056
United States
Baylor College of Medicine Center for Cell and Gene Therapy
Houston, Texas, 77030
United States
Renovatio Clinical Research
The Woodlands, Texas, 77380
United States
LDS Hospital/ Intermountain Healthcare
Salt Lake City, Utah, 84143
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
Swedish Center for Blood Disorders and Stem Cell Transplantation
Seattle, Washington, 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
St Vincent HSHS (Green Bay Oncology)
Green Bay, Wisconsin, 54301
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Stichting European Myeloma Network

  • Niels van de Donk, Professor, PRINCIPAL_INVESTIGATOR, Amsterdam UMC, Vrije Universiteit Amsterdam
  • Elena Zamagni, Professor, PRINCIPAL_INVESTIGATOR, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli"

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 Date2022-09-08
Study Completion Date2032-04

Study Record Updates

Study Start Date2022-09-08
Study Completion Date2032-04

Terms related to this study

Keywords Provided by Researchers

  • Maintenance
  • Teclistamab

Additional Relevant MeSH Terms

  • Multiple Myeloma