Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma
[EN]For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with hi...
| Autores: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2013 |
| País: | España |
| Institución: | Universidad de Salamanca (USAL) |
| Repositorio: | GREDOS. Repositorio Institucional de la Universidad de Salamanca |
| OAI Identifier: | oai:gredos.usal.es:10366/154298 |
| Acceso en línea: | http://hdl.handle.net/10366/154298 |
| Access Level: | acceso abierto |
| Palabra clave: | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Dexamethasone Disease Progression Female Follow-Up Studies Humans Induction Chemotherapy Lenalidomide Male Middle Aged Multiple Myeloma Risk Survival Rate Thalidomide talidomida protocolos de quimioterapia antineoplásica combinada dexametasona humanos anciano estudios de seguimiento mediana edad mieloma múltiple riesgo tasa de supervivencia quimioterapia de inducción adulto progresión de la enfermedad |
| id |
ES_4512f1fbf8c7eaa35fb519c17366ef0d |
|---|---|
| oai_identifier_str |
oai:gredos.usal.es:10366/154298 |
| network_acronym_str |
ES |
| network_name_str |
España |
| repository_id_str |
|
| spelling |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myelomaMateos Manteca, María VictoriaHernández, Miguel-TeodoroGiraldo, PilarDe la Rubia, JavierDe Arriba, FelipeLópez Corral, LucíaRosiñol, LauraPaiva, BrunoPalomera, LuisBargay, JoanOriol, AlbertPrósper, FelipeLópez, JavierOlavarría, EduardoQuintana, NuriaGarcía, José-LuisBladé, JoanLahuerta, Juan JoséSan Miguel Izquierdo, Jesús FernandoAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDisease ProgressionFemaleFollow-Up StudiesHumansInduction ChemotherapyLenalidomideMaleMiddle AgedMultiple MyelomaRiskSurvival RateThalidomideDisease ProgressionAgedAdultInduction ChemotherapyFollow-Up StudiesHumansAntineoplastic Combined Chemotherapy ProtocolsMiddle AgedMultiple MyelomaRiskThalidomideDexamethasoneSurvival Ratetalidomidaprotocolos de quimioterapia antineoplásica combinadadexametasonahumanosancianoestudios de seguimientomediana edadmieloma múltipleriesgotasa de supervivenciaquimioterapia de inducciónadultoprogresión de la enfermedad[EN]For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. (Funded by Celgene; ClinicalTrials.gov number, NCT00480363.).NEJM Group202420242013info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10366/154298reponame:GREDOS. Repositorio Institucional de la Universidad de Salamancainstname:Universidad de Salamanca (USAL)Inglésinfo:eu-repo/semantics/openAccessoai:gredos.usal.es:10366/1542982026-06-07T06:28:51Z |
| dc.title.none.fl_str_mv |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| title |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| spellingShingle |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma Mateos Manteca, María Victoria Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Dexamethasone Disease Progression Female Follow-Up Studies Humans Induction Chemotherapy Lenalidomide Male Middle Aged Multiple Myeloma Risk Survival Rate Thalidomide Disease Progression Aged Adult Induction Chemotherapy Follow-Up Studies Humans Antineoplastic Combined Chemotherapy Protocols Middle Aged Multiple Myeloma Risk Thalidomide Dexamethasone Survival Rate talidomida protocolos de quimioterapia antineoplásica combinada dexametasona humanos anciano estudios de seguimiento mediana edad mieloma múltiple riesgo tasa de supervivencia quimioterapia de inducción adulto progresión de la enfermedad |
| title_short |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| title_full |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| title_fullStr |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| title_full_unstemmed |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| title_sort |
Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma |
| dc.creator.none.fl_str_mv |
Mateos Manteca, María Victoria Hernández, Miguel-Teodoro Giraldo, Pilar De la Rubia, Javier De Arriba, Felipe López Corral, Lucía Rosiñol, Laura Paiva, Bruno Palomera, Luis Bargay, Joan Oriol, Albert Prósper, Felipe López, Javier Olavarría, Eduardo Quintana, Nuria García, José-Luis Bladé, Joan Lahuerta, Juan José San Miguel Izquierdo, Jesús Fernando |
| author |
Mateos Manteca, María Victoria |
| author_facet |
Mateos Manteca, María Victoria Hernández, Miguel-Teodoro Giraldo, Pilar De la Rubia, Javier De Arriba, Felipe López Corral, Lucía Rosiñol, Laura Paiva, Bruno Palomera, Luis Bargay, Joan Oriol, Albert Prósper, Felipe López, Javier Olavarría, Eduardo Quintana, Nuria García, José-Luis Bladé, Joan Lahuerta, Juan José San Miguel Izquierdo, Jesús Fernando |
| author_role |
author |
| author2 |
Hernández, Miguel-Teodoro Giraldo, Pilar De la Rubia, Javier De Arriba, Felipe López Corral, Lucía Rosiñol, Laura Paiva, Bruno Palomera, Luis Bargay, Joan Oriol, Albert Prósper, Felipe López, Javier Olavarría, Eduardo Quintana, Nuria García, José-Luis Bladé, Joan Lahuerta, Juan José San Miguel Izquierdo, Jesús Fernando |
| author2_role |
author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Dexamethasone Disease Progression Female Follow-Up Studies Humans Induction Chemotherapy Lenalidomide Male Middle Aged Multiple Myeloma Risk Survival Rate Thalidomide Disease Progression Aged Adult Induction Chemotherapy Follow-Up Studies Humans Antineoplastic Combined Chemotherapy Protocols Middle Aged Multiple Myeloma Risk Thalidomide Dexamethasone Survival Rate talidomida protocolos de quimioterapia antineoplásica combinada dexametasona humanos anciano estudios de seguimiento mediana edad mieloma múltiple riesgo tasa de supervivencia quimioterapia de inducción adulto progresión de la enfermedad |
| topic |
Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Dexamethasone Disease Progression Female Follow-Up Studies Humans Induction Chemotherapy Lenalidomide Male Middle Aged Multiple Myeloma Risk Survival Rate Thalidomide Disease Progression Aged Adult Induction Chemotherapy Follow-Up Studies Humans Antineoplastic Combined Chemotherapy Protocols Middle Aged Multiple Myeloma Risk Thalidomide Dexamethasone Survival Rate talidomida protocolos de quimioterapia antineoplásica combinada dexametasona humanos anciano estudios de seguimiento mediana edad mieloma múltiple riesgo tasa de supervivencia quimioterapia de inducción adulto progresión de la enfermedad |
| description |
[EN]For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. (Funded by Celgene; ClinicalTrials.gov number, NCT00480363.). |
| publishDate |
2013 |
| dc.date.none.fl_str_mv |
2013 2024 2024 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/10366/154298 |
| url |
http://hdl.handle.net/10366/154298 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.publisher.none.fl_str_mv |
NEJM Group |
| publisher.none.fl_str_mv |
NEJM Group |
| dc.source.none.fl_str_mv |
reponame:GREDOS. Repositorio Institucional de la Universidad de Salamanca instname:Universidad de Salamanca (USAL) |
| instname_str |
Universidad de Salamanca (USAL) |
| reponame_str |
GREDOS. Repositorio Institucional de la Universidad de Salamanca |
| collection |
GREDOS. Repositorio Institucional de la Universidad de Salamanca |
| repository.name.fl_str_mv |
|
| repository.mail.fl_str_mv |
|
| _version_ |
1869407137375977472 |
| score |
15.301603 |