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

Recruiting now · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05243797

Run by

European Myeloma Network B.V.

People needed

1594

Starts

2022-09-08

Expected to finish

2032-04-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Seidman Cancer Center-University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Ohio Health Research Institute — Columbus, Ohio, United States (enrolling)
• Banner University Medical Center Tucson, University of Arizona — Phoenix, Arizona, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Ohio State Medical Center, James Cancer Center — Columbus, Ohio, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Christiana Care — Newark, Delaware, United States (enrolling)
• University of California, San Diego (UCSD) Medical Center — San Diego, California, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Moffitt at Memorial Healthcare System — Tampa, Florida, United States (enrolling)
• University of California-Davis Cancer Center — Sacramento, California, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• University of Illinois Medical Center at Chicago — Chicago, Illinois, United States (enrolling)
• Greenebaum Cancer Center UM of MD — Baltimore, Maryland, United States (enrolling)
• John Hopkins — Baltimore, Maryland, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group — Orlando, Florida, United States (enrolling)
• Mount Sinai Medical Center - 2 — New York, New York, United States (enrolling)
• Montefiore Medical Cente — The Bronx, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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