Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials.
Renal impairment (RI) is a major comorbidity in patients with multiple myeloma (MM). Here we present the pooled safety and efficacy analysis of three clinical trials (MM-002, MM-003, and MM-010) of pomalidomide + low-dose dexamethasone (POM + LoDEX) in patients with moderate RI (creatinine clearance [CrCl] ≥ 30 to <60 mL/min) and without RI (≥ 60 mL/min). Trial protocols were approved by the institutional review board of each site involved. Patients with RI were older than patients without RI, although other baseline characteristics were similar. The dosing and safety profile of POM + LoDEX was similar across RI subgroups. Median overall response rate, progression-free survival, time to progression, and duration of response were not significantly different between RI subgroups. However, patients with vs. without RI had significantly shorter median overall survival (10.5 vs. 14.0 months, respectively; p = .004). This analysis demonstrates that POM + LoDEX is a safe and effective treatment for patients with moderate RI. The trials were registered at ClinicalTrials.gov as NCT00833833 (MM-002), NCT01311687 (MM-003), and NCT01712789 (MM-010) and at EudraCT as 2010-019820-30 (MM-003) and 2012-001888-78 (MM-010).
a Division of Multiple Myeloma, John Theurer Cancer Center , Hackensack University Medical Center , Hackensack , NJ , USA.
David S
DS
Siegel
b Department of Hematology, Oncology, Immunology, Rheumatology and Pulmonology , University Hospital of Tübingen , Tübingen , Germany.
Katja C
KC
Weisel
c Department of Clinical Therapeutics at the University , National and Kapodistrian University of Athens School of Medicine , Athens , Greece.
Meletios A
MA
Dimopoulos
d Department of Malignant Hematology , Moffitt Cancer Center and Research Institute , Tampa , FL , USA.
Rachid
R
Baz
e Myeloma Program , Dana-Farber Cancer Institute , Boston , MA , USA.
Paul
P
Richardson
f Department of Hematology , University Hospitals Leuven , Leuven , Belgium.
Michel
M
Delforge
g Division of Hematology , Vancouver General Hospital , Vancouver , British Columbia , Canada.
Kevin W
KW
Song
h Director of Clinical and Translational Medicine , Clinica Universidad de Navarra, CIMA, IDISNA , Pamplona , Spain.
Jesus F
JF
San Miguel
i Hematology Department , CHU Hotel Dieu-CHU de Nantes , France.
Philippe
P
Moreau
j Department of Medicine V , University of Heidelberg , Heidelberg , Germany.
Hartmut
H
Goldschmidt
k "Seràgnoli" Institute of Hematology , Bologna University School of Medicine , Bologna , Italy.
Michele
M
Cavo
l Tisch Cancer Institute , Mount Sinai Hospital , New York City , NY , USA.
Sundar
S
Jagannath
m Celgene Corporation , Summit , NJ , USA.
Xin
X
Yu
m Celgene Corporation , Summit , NJ , USA.
Kevin
K
Hong
m Celgene Corporation , Summit , NJ , USA.
Lars
L
Sternas
m Celgene Corporation , Summit , NJ , USA.
Mohamed
M
Zaki
n Department of Hematology , University of Turin , Turin , Italy.
Antonio
A
Palumbo
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy* / Q000473:pathology*; D009367:Neoplasm Staging; D012008:Recurrence; D051437:Renal Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology; D019233:Retreatment; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide
IMiD; pomalidomide; relapsed/refractory multiple myeloma; renal impairment