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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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion 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.

Exclusion Criteria:

* 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.

About the study

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.

What is being tested

Sponsor: European Myeloma Network B.V. · Participants: 1,594 · Started: Sep 8, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05243797

Locations in the U.S.

ArizonaBanner University Medical Center Tucson, University of Arizona, Phoenix
CaliforniaUCLA Medical Center, Los Angeles (Not yet recruiting)
University of California-Davis Cancer Center, Sacramento
University of California, San Diego (UCSD) Medical Center, San Diego
ColoradoUniversity of Colorado Hospital, Aurora
Colorado Blood Cancer Institute, Denver
ConnecticutYale New Haven Hospital, New Haven
DelawareChristiana Care, Newark
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaAdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group, Orlando
Moffitt at Memorial Healthcare System, Tampa
GeorgiaEmory University Hospital, Atlanta
IllinoisUniversity of Chicago, Chicago (Not yet recruiting)
University of Illinois Medical Center at Chicago, Chicago
MarylandGreenebaum Cancer Center UM of MD, Baltimore
John Hopkins, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston
Tufts Medical Center, Boston
MichiganHenry Ford St. John Hospital, Grosse Pointe Woods (Not yet recruiting)
New YorkMount Sinai Medical Center - 2, New York
Montefiore Medical Cente, The Bronx
North CarolinaLevine Cancer Institute, Charlotte
Duke University, Durham
East Carolina University, Greenville (Not yet recruiting)
OhioUniversity of Cincinnati, Cincinnati
Seidman Cancer Center-University Hospitals Cleveland Medical Center, Cleveland
Ohio Health Research Institute, Columbus
Ohio State Medical Center, James Cancer Center, Columbus
PennsylvaniaLehigh Valley Health Network, Allentown
Penn Medicine Lancaster General, Lancaster (Not yet recruiting)
Abramson Cancer Center University of Pennsylvania Medical Center, Philadelphia
Fox Chase Cancer Center, Philadelphia
UPMC Hillman Cancer Center, Pittsburgh (Not yet recruiting)
South CarolinaMedical University of South Carolina (MUSC), Charleston
Gibbs Cancer Center, Spartanburg
TennesseeVanderbilt-Ingram Cancer Center (VICC), Nashville
TexasHouston Methodist Hospital, Houston
VirginiaVirginia Oncology Associates, Norfolk
WisconsinSt Vincent HSHS (Green Bay Oncology), Green Bay
University of Wisconsin Hospital and Clinics, Madison
Froedtert Memorial Lutheran Hospital, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.