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Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
- Source :
- Biblos-e Archivo. Repositorio Institucional de la UAM, instname, Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid
- Publication Year :
- 2015
- Publisher :
- Ferrata Storti Foundation, 2015.
-
Abstract
- Pomalidomide is a distinct oral IMiD immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment. Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status. Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response). These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment. ClinicalTrials.gov: NCT01311687; EudraCT: 2010-019820-30. ispartof: Haematologica vol:100 issue:10 pages:1334-9 ispartof: location:Italy status: published
- Subjects :
- Oncology
Male
medicine.medical_specialty
MM-003
Medicina
Pharmacology
Dexamethasone
Recurrence
Multiple myeloma
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Survival analysis
Lenalidomide
Aged
Aged, 80 and over
Bortezomib
business.industry
MM, Pomalidomide, pomalidomide + low-dose dexamethasone, high-dose dexamethasone
Hematology
Articles
Pomalidomide
medicine.disease
Survival Analysis
Thalidomide
Treatment
Treatment Outcome
Tolerability
Retreatment
Female
business
Multiple Myeloma
medicine.drug
Follow-Up Studies
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Biblos-e Archivo. Repositorio Institucional de la UAM, instname, Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid
- Accession number :
- edsair.doi.dedup.....ecbf4ad1633806b6c038469c7cd17a8c