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RECRUITING
NCT07107529
PHASE2

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Sponsor: European Myeloma Network B.V.

View on ClinicalTrials.gov

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

Interventions

DRUG

Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

DRUG

Talquetamab

Talquetamab will be administered via a subcutaneous injection (SC), fixed duration and will be retreated until disease progression or intolerable toxicity.

DRUG

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