A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
• Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
• Participants must have measurable disease as defined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have clinical laboratory values within a prespecified range.
Locations
Other Locations
Australia
Austin Hospital
RECRUITING
Heidelberg
Nepean Cancer Centre
RECRUITING
Kingswood
Sunshine Coast Health
RECRUITING
Sunshine Coast
Austria
Ordensklinikum Linz
RECRUITING
Linz
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Germany
University Hospital of Würzburg
RECRUITING
Würzburg
Italy
AOU Ospedali Riuniti di Ancona
RECRUITING
Ancona
A.O.U. Careggi
RECRUITING
Florence
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
RECRUITING
Meldola
Azienda USL IRCCS Di Reggio Emilia
RECRUITING
Reggio
Ospedale Infermi di Rimini
RECRUITING
Rimini
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Norway
Stavanger University Hospital
RECRUITING
Stavanger
Vestfold Hospital Trust
RECRUITING
Tønsberg
St. Olavs hospital HF
RECRUITING
Trondheim
Portugal
CHUC
RECRUITING
Coimbra
Hospital da Luz Lisboa
RECRUITING
Lisbon
Spain
Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit
RECRUITING
Barcelona
Hospital Quirón Salud Madrid
RECRUITING
Madrid
Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service
RECRUITING
Santander
Hospital Universitario la Fe, Valencia
RECRUITING
Valencia
Switzerland
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie