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

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.

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Phoenix

The University of Arizona Cancer Center, Phoenix, Arizona, United States, 85004

Sacramento

University of California-Davis Cancer Center, Sacramento, California, United States, 95817

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06519

Orlando

Blood & Marrow Transplant Center, Florida Hospital Medical Group, Orlando, Florida, United States, 32804

Tampa

Moffitt at Memorial Healthcare System, Tampa, Florida, United States, 33612

Chicago

University of Illinois Medical Center at Chicago, Chicago, Illinois, United States, 60612

Indianapolis

IU Health Blood and Bone Marrow Stem Cell Transplant and Immune Cell Therapy Program, Indianapolis, Indiana, United States, 46202

Baltimore

Greenebaum Cancer Center UM of MD, Baltimore, Maryland, United States, 21201

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must have a new diagnosis of multiple myeloma according to IMWG criteria and have received induction +/- consolidation.
  • * 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.
  • * Must not be intolerant to the starting dose of lenalidomide.
  • * Must not have received any maintenance therapy.
  • * Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
  • * Have clinical laboratory values within prespecified range.
  • * Received any prior BCMA-directed therapy.
  • * Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells).
  • * Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
  • * Progressed on multiple myeloma therapy at any time prior to screening.
  • * Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2032-04