Teclistamab with Lenalidomide for Newly Diagnosed Multiple Myeloma
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
Phase 3Interventional Study
Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,594 (estimated)
Sponsor
European Myeloma Network B.V. · Research network
Who this trial is looking for
This trial is looking for people with newly diagnosed multiple myeloma who have received initial treatment and are interested in new maintenance therapies. Participants will receive either teclistamab combined with lenalidomide, teclistamab alone, or just lenalidomide after their stem cell transplant.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple myeloma.
I have received one line of therapy and had at least a partial response.
I am not intolerant to lenalidomide.
I have not received any maintenance therapy.
I have a performance status score of 0, 1, or 2.
My lab values are within the required range.
You may not be able to join if
I have received any treatment aimed at BCMA before.
I have had previous treatment with immune cell redirecting agents.
I stopped treatment due to side effects from lenalidomide.
I have progressed in my multiple myeloma therapy before screening.
I have taken corticosteroids equivalent to 140 mg of prednisone in the last 14 days.
I have received a live vaccine in the past 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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