Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Bortezomib
/ administration & dosage
Combined Modality Therapy
Consolidation Chemotherapy
/ mortality
Cyclophosphamide
/ administration & dosage
Dexamethasone
/ administration & dosage
Female
Follow-Up Studies
Hematopoietic Stem Cell Transplantation
/ mortality
Humans
Lenalidomide
/ administration & dosage
Maintenance Chemotherapy
/ mortality
Male
Melphalan
/ administration & dosage
Multiple Myeloma
/ pathology
Prognosis
Prospective Studies
Remission Induction
Survival Rate
Thalidomide
/ administration & dosage
Transplantation, Autologous
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
03
09
2019
accepted:
22
01
2020
revised:
27
12
2019
pubmed:
9
2
2020
medline:
28
10
2020
entrez:
9
2
2020
Statut:
ppublish
Résumé
The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.
Identifiants
pubmed: 32034285
doi: 10.1038/s41375-020-0724-1
pii: 10.1038/s41375-020-0724-1
doi:
Substances chimiques
Thalidomide
4Z8R6ORS6L
Bortezomib
69G8BD63PP
Dexamethasone
7S5I7G3JQL
Cyclophosphamide
8N3DW7272P
Lenalidomide
F0P408N6V4
Melphalan
Q41OR9510P
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1853-1865Références
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