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Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
Sponsor: European Myeloma Network B.V.
Summary
This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab. The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).
Official title: EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-12-12
Completion Date
2034-02
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Talquetamab
Talquetamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Daratumumab
Dartumumab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.
Locations (29)
IT-Ascoli Piceno-Ospedale Mazzoni [01-016]
Ascoli Piceno, Italy
IT-Bari-A.O.U. Consorziale Policlinico - Medicina Interna [01-018]
Bari, Italy
IT-Bergamo-A.O. Papa Giovanni XXIII [01-003]
Bergamo, Italy
IT-Bologna-A.O.U. di Bologna - Policlinico S. Orsola Malpighi [01-004]
Bologna, Italy
IT-Bolzano-Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige [01-021]
Bolzano, Italy
IT-Como-Ospedale Classificato Valduce [01-104]
Como, Italy
IT-Milano-Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico [01-039]
Milan, Italy
IT-Milano-Ospedale S. Carlo Borromeo [01-105]
Milan, Italy
IT-Novara-A.O.U. Maggiore della Carità [01-010]
Novara, Italy
IT-Pescara-Azienda USL di Pescara P.O. dello Spirito Santo [01-053]
Pescara, Italy
IT-Roma-ASL Roma 1 [01-101]
Roma, Italy
IT-Roma-Policlinico Umberto I - Università 'Sapienza' [01-013]
Roma, Italy
IT-Torino-A.O.U. Città della Salute e della Scienza di Torino-SSD Clinical trials [01-001]
Torino, Italy
IT-Varese-Ospedale di Circolo [01-111]
Varese, Italy
NL-Amsterdam-Vrije Universiteit Medical Center (VUMC) [02-007]
Amsterdam, Netherlands
NL-Arnhem-Rijnstate Hospital [02-009]
Arnhem, Netherlands
NL-Enschede-Medisch Spectrum Twente [02-024]
Enschede, Netherlands
NL-Groningen-University Medical Center Groningen [02-030]
Groningen, Netherlands
NL-Nieuwegein-S. Antonius Hospital [02-038]
Nieuwegein, Netherlands
NL-Schiedam-Franciscus Vlietland Hospital [02-049]
Schiedam, Netherlands
NL-Sittard-Geleen-Zuyderland Medical Center [02-058]
Sittard, Netherlands
NL-Den Haag-Haga Ziekenhuis [02-016]
The Hague, Netherlands
NL-Zwolle-Isala Klinieken [02-057]
Zwolle, Netherlands
NO-Oslo-Oslo University Hospital [23-007]
Oslo, Norway
NO-Tønsberg-Vestfold Hospital Trust [23-012]
Tønsberg, Norway
ES-Barcelona-H.U. Vall d'Hebrón [06-002]
Barcelona, Spain
ES-Las Palmas-H.U. de Gran Canaria Dr Negrín [06-030]
Las Palmas, Spain
ES-Murcia-H.U. Virgen de la Arrixaca [06-016]
Murcia, Spain
ES-Salamanca-H.U. de Salamanca [06-021]
Salamanca, Spain