A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible
Date de révision : 29/04/2026
29 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 28/04/2026
Critères :
Critères d'inclusion :
- 18 years of age or older
- Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
- Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: 1) Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2) Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- ECOG performance status of grade 0 or 1
- Clinical laboratory values within prespecified range as listed in 5.1.1, page 55 of the protocol.
Critères d'exclusion :
- Prior treatment with CAR-T therapy directed at any target.
- Any prior BCMA target therapy.
- Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
- Received a strong cytochrome P450 (CYP)3A4 inducer within 5 halflives prior to randomization
- Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
- Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Institut Universitaire Du Cancer Toulouse-Oncopole
31059 Toulouse Cedex 9 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".