Recruiting

Phase 3

Teclistamab & LenalidomidePhase 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

Sponsor:

European Myeloma Network B.V.

Code:

NCT05243797

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Teclistamab

Lenalidomide

Study Details

Brief summary:

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

Study ID

NCT05243797

Start date

Sep 8, 2022

Status verified date

Jun, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1594 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)

Teclistamab will be administered via a subcutaneous injection (SC)

active comparator: Arm B Lenalidomide Alone (Len)

Lenalidomide orally.

experimental: Arm C Teclistamab-Alone (Tec)

Teclistamab will be administered via a subcutaneous injection (SC)

Interventions

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

Lenalidomide

Lenalidomide will be administered orally

Primary outcome measure

Progression Free Survival (PFS) [ Time Frame: from randomization to the date of disease progression or death (approximately up to 8 years) ]
Minimal Residual Disease (MRD)-negative Complete Response (CR) [ Time Frame: at month 12 ]

Central Contacts and Locations

Central contacts

Christine Witty

+31 10 268 70 65 Christine.Witty@emn.org

Sabrin Tahri

+31 10 268 70 65 Sabrin.Tahri@emn.org

Locations

Banner University Medical Center Tucson, University of Arizona

Recruiting

Phoenix, Arizona, United States, 85004

University of California-Davis Cancer Center

Recruiting

Sacramento, California, United States, 95817

University of California, San Diego (UCSD) Medical Center

Recruiting

San Diego, California, United States, 92093

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06519

Christiana Care

Recruiting

Newark, Delaware, United States, 19718

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group

Recruiting

Orlando, Florida, United States, 32804

Moffitt at Memorial Healthcare System

Recruiting

Tampa, Florida, United States, 33612

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

University of Illinois Medical Center at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Greenebaum Cancer Center UM of MD

Recruiting

Baltimore, Maryland, United States, 21201

John Hopkins

Recruiting

Baltimore, Maryland, United States, 21218

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Mount Sinai Medical Center - 2

Recruiting

New York, New York, United States, 10029

Montefiore Medical Cente

Recruiting

The Bronx, New York, United States, 10467

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Duke University

Recruiting

Durham, North Carolina, United States, 27710

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

Seidman Cancer Center-University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Ohio State Medical Center, James Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Ohio Health Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Abramson Cancer Center University of Pennsylvania Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Gibbs Cancer Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Vanderbilt-Ingram Cancer Center (VICC)

Recruiting

Nashville, Tennessee, United States, 37232

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

St Vincent HSHS (Green Bay Oncology)

Recruiting

Green Bay, Wisconsin, United States, 54301

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Froedtert Memorial Lutheran Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Cross Cancer Institute

Recruiting

Edmonton, Canada

QEII Health Sciences Centre

Recruiting

Halifax, Canada

The Ottawa General Hospital

Recruiting

Ottawa, Canada

Saskatoon Cancer Center

Recruiting

Saskatoon, Canada

"Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)"

Recruiting

Sherbrooke, Canada

Princess Margaret Cancer Centre

Recruiting

Toronto, Canada

BC Cancer

Recruiting

Vancouver, Canada

More Information

Sponsor

European Myeloma Network B.V.

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

Maintenance
Teclistamab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by European Myeloma Network B.V. on 2026-06-04.