Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment.
Aged
Antibodies, Monoclonal
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Dexamethasone
/ therapeutic use
Female
Humans
Lenalidomide
/ therapeutic use
Male
Multiple Myeloma
/ drug therapy
Neoplasm Recurrence, Local
/ drug therapy
Progression-Free Survival
Thalidomide
/ analogs & derivatives
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
09
01
2020
accepted:
20
03
2020
revised:
06
03
2020
pubmed:
8
5
2020
medline:
5
1
2021
entrez:
8
5
2020
Statut:
ppublish
Résumé
Patients with multiple myeloma who have relapsed after or become refractory to lenalidomide in early treatment lines represent a clinically important population in need of effective therapies. The safety and efficacy of pomalidomide, low-dose dexamethasone, and daratumumab was evaluated in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM) after one to two prior treatment lines in the phase 2 MM-014 study. Patients received pomalidomide 4 mg daily from days 1-21 and dexamethasone 40 mg weekly (28-day cycles). Daratumumab 16 mg/kg was administered per label. Primary endpoint was overall response rate (ORR); secondary endpoints included progression-free survival (PFS) and safety. Per protocol, all patients (N = 112) had received lenalidomide in their most recent prior regimen (75.0% lenalidomide refractory). ORR was 77.7% (76.2% in lenalidomide-refractory patients); median follow-up was 17.2 months. Median PFS was not reached (1-year PFS rate 75.1%). The most common hematologic grade 3/4 treatment-emergent adverse event was neutropenia (62.5%). Grade 3/4 infections were reported in 31.3% of patients, including 13.4% with grade 3/4 pneumonia. These results demonstrate the safety and efficacy of pomalidomide-based therapy as early as second line in patients with RRMM, even immediately after lenalidomide failure, indicating that switching from the immunomodulatory agent class is not necessary.
Identifiants
pubmed: 32376855
doi: 10.1038/s41375-020-0813-1
pii: 10.1038/s41375-020-0813-1
pmc: PMC7685974
doi:
Substances chimiques
Antibodies, Monoclonal
0
daratumumab
4Z63YK6E0E
Thalidomide
4Z8R6ORS6L
Dexamethasone
7S5I7G3JQL
pomalidomide
D2UX06XLB5
Lenalidomide
F0P408N6V4
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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