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Recruiting Phase 3 NCT05243797

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

Phase 3 – large-scale trial before approval
Conditions: Multiple Myeloma

Sponsor: European Myeloma Network B.V.

trial.available_in: БГ
Overview
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 participate
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.
Locations 22
Argentina (1)
Hospital Italiano
Buenos Aires
Australia (1)
Sunshine Coast Health
Birtinya , Queensland
Belgium (1)
Jessa Ziekenhuis
Hasselt
Brazil (1)
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre
Canada (1)
Cross Cancer Institute
Edmonton
China (1)
Beijing Chaoyang Hospital
Beijing
Czech Republic (1)
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Denmark (1)
Aarhus Universitetshospital
Aarhus
France (1)
Centre Hospitalier Universitaire De Bordeaux
Bordeaux
Greece (1)
University General Hospital Of Alexandroupoli
Alexandroupoli
Ireland (1)
Cork University Hospital
Cork
Israel (1)
The Barzilai Medical Center
Beersheba
Italy (1)
Azienda Sanitaria Locale Al Di Alessandria
Alessandria
Netherlands (1)
Noordwest Ziekenhuisgroep Stichting
Alkmaar
Norway (1)
St. Olavs hospital HF
Trondheim
Poland (1)
Department of Hematology and Transplantology University Clinical Center
Gdansk
ACTIVE_NOT_RECRUITING
Serbia (1)
University Clinical Center of Serbia
Belgrade
South Korea (1)
Chonnam National University Hwasun Hospital
Gwangju
Switzerland (1)
University Hospital Basel
Basel
Turkey (1)
Ankara Liv Hospital
Ankara
United Kingdom (1)
Hammersmith Hospital - Imperial College NHS Healthcare Trust
London
United States (1)
Banner University Medical Center Tucson, University of Arizona
Phoenix , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.09.2022
Completion date
01.04.2032
Registry ID
NCT05243797
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.