PB2020: MAJESTEC-3: RANDOMIZED, PHASE 3 STUDY OF TECLISTAMAB PLUS DARATUMUMAB VERSUS DPD OR DVD IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Notice bibliographique
Résumé
Background: Treatment of relapsed/refractory multiple myeloma (RRMM) in patients (pts) previously treated with a proteasome inhibitor (PI) and lenalidomide is challenging. Although daratumumab plus pomalidomide and dexamethasone (DPd), and bortezomib and dexamethasone (DVd) are approved for RRMM, further disease control is still needed. Thus, newer therapeutic options with diverse modes of action are warranted. Teclistamab (tec; JNJ-64007957), a B-cell maturation antigen (BCMA) x CD3 bispecific antibody (Ab), induces T cell activation and subsequent lysis of BCMA-expressing myeloma cells. Results from the phase 1 MajesTEC-1 study (NCT03145181) demonstrated that teclistamab was generally well-tolerated with encouraging efficacy in pts with RRMM who were heavily pretreated. In the phase 1b TRIMM-2 study (NCT04108195), teclistamab plus daratumumab (tec-dara) provided promising efficacy and was also well tolerated. Aims: To describe MajesTEC-3 (NCT05083169), a phase 3, multicenter, open-label, randomized study comparing the efficacy of tec-dara and investigator’s choice of therapy (DPd or DVd) in pts with RRMM. Methods: Eligible patients (pts) are ≥18 years of age with documented MM based on the International Myeloma Working Group (IMWG) criteria and have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0–2, previous exposure to 1–3 lines of treatment (tx) which may include a PI and lenalidomide (of note, pts with 1 prior tx line must be lenalidomide-refractory), and progressive disease status on or following their last tx (or within 60 days of completing lenalidomide). Informed consent form will be signed before the first study-related activity is conducted. Pts who are refractory to an anti-CD38 monoclonal antibody or had prior BCMA-directed tx are excluded. Pts (560 planned) will be randomly assigned (1:1) to receive 28-day cycles of tec-dara or investigator’s choice of DPd or DVd (stratified by investigator’s choice of DPd or DVd, ISS stage, and number of lines of prior tx). Pts will receive dara, DPd, and DVd tx per the approved schedules and will be treated until disease progression, death, withdrawal of consent, intolerable toxicity, or end of study, whichever occurs first. Assessment of responses will be based on 2016 IMWG criteria. The primary endpoint will be progression-free survival (PFS), and secondary endpoints will include overall response rate, complete response or better, MRD negativity, PFS on next-line tx (PFS2), overall survival, and incidence and severity of adverse events (AEs). All reported AEs will be graded as per the Common Terminology Criteria for AEs (CTCAE) v5.0. Immune effector cell-associated neurotoxicity syndrome and cytokine release syndrome will be graded per the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. MajesTEC-3 opened in October 2021 and is currently enrolling pts. Results: Not applicable Summary/Conclusion: Not applicable
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».