Continuous lenalidomide treatment after bortezomib-melphalan-prednisolone therapy for newly diagnosed multiple myeloma.

Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols / administration & dosage Bortezomib / administration & dosage Disease-Free Survival Female Humans Lenalidomide / administration & dosage Male Melphalan / administration & dosage Middle Aged Multiple Myeloma / diagnosis Prednisolone / administration & dosage Survival Rate

Bortezomib Dexamethasone Lenalidomide Multiple myeloma Transplant ineligible

Journal

Annals of hematology

ISSN: 1432-0584

Titre abrégé: Ann Hematol

Pays: Germany

ID NLM: 9107334

Informations de publication

Date de publication:
May 2020

Historique:

received: 10 09 2019

accepted: 01 03 2020

pubmed: 6 4 2020

medline: 19 5 2020

entrez: 6 4 2020

Statut: ppublish

Résumé

These are the results of phase II study of bortezomib-melphalan-prednisolone (VMP) induction therapy followed by lenalidomide-dexamethasone (Rd) consolidation and lenalidomide maintenance in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), overall response rates (ORRs), and safety. Eighty-three eligible patients were enrolled between October 2012 and August 2014. The median PFS was 28.0 months (95% CI 19.6-36.7) and the median OS was 55.3 months (95% CI 51.6-NA). Among the patients who received lenalidomide maintenance therapy, median PFS was significantly improved in patients who had achieved a very good partial response (VGPR) or better (41.8 vs 20.7 months, p = 0.0070). As the best response, the rates of partial response or better were 85.5% comprising stringent complete response (sCR, 21.7%), complete response (CR, 10.8%), VGPR (18.1%), and partial response (PR, 34.9%). The most frequently observed grade 3 or higher adverse events during the VMP therapy were anemia (28.9%), neutropenia (15.6%), thrombocytopenia (6.0%), and peripheral neuropathy (2.4%). The most frequently observed grade 3 or higher adverse events during the Rd therapy were anemia (3.5%), neutropenia (1.8%), and skin rush (5.3%). The most frequently observed grade 3 or higher adverse events during lenalidomide maintenance therapy were anemia (7.4%) and neutropenia (24.1%). Thus, VMP induction therapy followed by Rd consolidation and lenalidomide maintenance is considered a well-tolerated and effective regimen in transplant-ineligible NDMM. This trial is registered with UMIN-CTR with the identification number UMIN000009042.

Identifiants

DOI: 10.1007/s00277-020-03988-6 PMID: 32248251

pubmed: 32248251

doi: 10.1007/s00277-020-03988-6

pii: 10.1007/s00277-020-03988-6

doi:

Substances chimiques

Bortezomib 69G8BD63PP

Prednisolone 9PHQ9Y1OLM

Lenalidomide F0P408N6V4

Melphalan Q41OR9510P

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

1063-1072

Références

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