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 NCT05243797
Run by European Myeloma Network B.V. · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join 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 be able to join 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 this trial is running
- Banner University Medical Center Tucson, University of Arizona, Phoenix, Arizona, United States
- UCLA Medical Center, Los Angeles, California, United States
- University of California-Davis Cancer Center, Sacramento, California, United States
- University of California, San Diego (UCSD) Medical Center, San Diego, California, United States
- University of Colorado Hospital, Aurora, Colorado, United States
- Colorado Blood Cancer Institute, Denver, Colorado, United States
- Yale New Haven Hospital, New Haven, Connecticut, United States
- Christiana Care, Newark, Delaware, United States
- Sibley Memorial Hospital, Washington D.C., District of Columbia, United States
- AdventHealth/Blood & Marrow Transplant Center, Florida Hospital Medical Group, Orlando, Florida, United States
- Moffitt at Memorial Healthcare System, Tampa, Florida, United States
- Emory University Hospital, Atlanta, Georgia, United States
+ 200 more sites.
Who to contact
Christine Witty · +31 10 268 70 65 · Christine.Witty@emn.org
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05243797.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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