A prospective phase II of daratumumab in ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
A prospective phase II of daratumumab in previously treated systemic light chain amyloidosis (AL) patients.
Auteur(s) :
Roussel, Murielle [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Merlini, Giampaolo [Auteur]
Istituto di Ricovero e Cura a Carattere Scientifico [IRCCS]
Chevret, Sylvie [Auteur]
Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité [CRESS (U1153 / UMR_A_1125 / UMR_S_1153)]
Arnulf, Bertrand [Auteur]
Service d'Immunopathologie [Hôpital Saint-Louis, Paris]
Stoppa, Anne Marie [Auteur]
Institut Paoli-Calmettes [IPC]
Perrot, Aurore [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Palladini, Giovanni [Auteur]
Istituto di Ricovero e Cura a Carattere Scientifico [IRCCS]
Karlin, Lionel [Auteur]
Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL]
Royer, Bruno [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Huart, Antoine [Auteur]
Département de Néphrologie et Transplantation d'organes [CHU Toulouse]
Macro, Margaret [Auteur]
CHU Caen
Morel, Pierre [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Frenzel, Laurent [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Touzeau, Cyrille [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Boyle, Eileen [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Dorvaux, Véronique [Auteur]
Centre hospitalier régional Metz-Thionville [CHR Metz-Thionville]
Le Bras, Fabien [Auteur]
Hôpital Henri Mondor
Lavergne, David [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Bridoux, Frank [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Jaccard, Arnaud [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Merlini, Giampaolo [Auteur]
Istituto di Ricovero e Cura a Carattere Scientifico [IRCCS]
Chevret, Sylvie [Auteur]
Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité [CRESS (U1153 / UMR_A_1125 / UMR_S_1153)]
Arnulf, Bertrand [Auteur]
Service d'Immunopathologie [Hôpital Saint-Louis, Paris]
Stoppa, Anne Marie [Auteur]
Institut Paoli-Calmettes [IPC]
Perrot, Aurore [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Palladini, Giovanni [Auteur]
Istituto di Ricovero e Cura a Carattere Scientifico [IRCCS]
Karlin, Lionel [Auteur]
Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL]
Royer, Bruno [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Huart, Antoine [Auteur]
Département de Néphrologie et Transplantation d'organes [CHU Toulouse]
Macro, Margaret [Auteur]
CHU Caen
Morel, Pierre [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Frenzel, Laurent [Auteur]
Hôpital Necker - Enfants Malades [AP-HP]
Touzeau, Cyrille [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Boyle, Eileen [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Dorvaux, Véronique [Auteur]
Centre hospitalier régional Metz-Thionville [CHR Metz-Thionville]
Le Bras, Fabien [Auteur]
Hôpital Henri Mondor
Lavergne, David [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Bridoux, Frank [Auteur]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital [CHU de Poitiers [La Milétrie]]
Jaccard, Arnaud [Auteur]
Service d'Hématologie clinique et thérapie cellulaire [CHU Limoges]
Titre de la revue :
Blood
Nom court de la revue :
Blood
Date de publication :
2020-02-29
ISSN :
1528-0020
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Daratumumab is a human monoclonal antibody targeting CD38, an antigen uniformly expressed by plasma cells in multiple myeloma and light-chain amyloidosis (AL). We report the results of a prospective multicenter phase 2 ...
Lire la suite >Daratumumab is a human monoclonal antibody targeting CD38, an antigen uniformly expressed by plasma cells in multiple myeloma and light-chain amyloidosis (AL). We report the results of a prospective multicenter phase 2 study of daratumumab monotherapy in AL (NCT02816476). Forty previously treated AL patients with a difference between involved and uninvolved free light chains (dFLC) >50 mg/L were included in 15 centers between September of 2016 and April of 2018. Patients received 6 28-day cycles of IV daratumumab, every week for cycles 1 and 2 and every 2 weeks for cycles 3 through 6. Median age was 69 years (range, 45-83). Twenty-six patients had ≥2 organs involved, with heart in 24 and kidney in 26. Median time from diagnosis to enrollment was 23 months (interquartile range, 4-122), with a median of 3 prior therapies (range, 1-5). At data cutoff (September of 2019), all patients discontinued therapy; 33 received the planned 6 cycles. Overall, 22 patients had hematological response, and 19 patients (47.5%) achieved very good partial response (dFLC <40 mg/L) or better. Median time to hematological response was 1 week. Patients with no response after 4 doses were unlikely to respond further. Renal and cardiac responses occurred in 8 and 7 patients, respectively. Daratumumab was well tolerated, with no unexpected adverse events. With a median follow-up of 26 months, the 2-year overall survival rate was 74% (95% confidence interval, 62-81). Daratumumab monotherapy is associated with deep and rapid hematological responses in previously treated AL patients, with a good safety profile. Further studies of daratumumab in combination regimens are warranted.Lire moins >
Lire la suite >Daratumumab is a human monoclonal antibody targeting CD38, an antigen uniformly expressed by plasma cells in multiple myeloma and light-chain amyloidosis (AL). We report the results of a prospective multicenter phase 2 study of daratumumab monotherapy in AL (NCT02816476). Forty previously treated AL patients with a difference between involved and uninvolved free light chains (dFLC) >50 mg/L were included in 15 centers between September of 2016 and April of 2018. Patients received 6 28-day cycles of IV daratumumab, every week for cycles 1 and 2 and every 2 weeks for cycles 3 through 6. Median age was 69 years (range, 45-83). Twenty-six patients had ≥2 organs involved, with heart in 24 and kidney in 26. Median time from diagnosis to enrollment was 23 months (interquartile range, 4-122), with a median of 3 prior therapies (range, 1-5). At data cutoff (September of 2019), all patients discontinued therapy; 33 received the planned 6 cycles. Overall, 22 patients had hematological response, and 19 patients (47.5%) achieved very good partial response (dFLC <40 mg/L) or better. Median time to hematological response was 1 week. Patients with no response after 4 doses were unlikely to respond further. Renal and cardiac responses occurred in 8 and 7 patients, respectively. Daratumumab was well tolerated, with no unexpected adverse events. With a median follow-up of 26 months, the 2-year overall survival rate was 74% (95% confidence interval, 62-81). Daratumumab monotherapy is associated with deep and rapid hematological responses in previously treated AL patients, with a good safety profile. Further studies of daratumumab in combination regimens are warranted.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Date de dépôt :
2023-11-15T09:16:18Z
2023-12-07T13:43:31Z
2023-12-07T13:43:31Z