Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone.
In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 7·0 months (12·7 vs. 5·7 months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Gareth
G
Morgan
Antonio
A
Palumbo
Sujith
S
Dhanasiri
Dawn
D
Lee
Katja
K
Weisel
Thierry
T
Facon
Michel
M
Delforge
Albert
A
Oriol
Mohamed
M
Zaki
Xin
X
Yu
Lars
L
Sternas
Christian
C
Jacques
Ron
R
Akehurst
Fritz
F
Offner
Meletios A
MA
Dimopoulos
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015982:Bias; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy*; D012008:Recurrence; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide
bias; crossover; multiple myeloma; pomalidomide; survival