Τίτλος:
Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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). © 2016 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Συγγραφείς:
Siegel, D.S.
Weisel, K.C.
Dimopoulos, M.A.
Baz, R.
Richardson, P.
Delforge, M.
Song, K.W.
San Miguel, J.F.
Moreau, P.
Goldschmidt, H.
Cavo, M.
Jagannath, S.
Yu, X.
Hong, K.
Sternas, L.
Zaki, M.
Palumbo, A.
Περιοδικό:
Clinical Lymphoma Myeloma and Leukemia
Εκδότης:
Taylor and Francis Ltd.
Λέξεις-κλειδιά:
creatinine; dexamethasone; pomalidomide; antineoplastic agent; dexamethasone; pomalidomide; thalidomide, adult; aged; anemia; Article; cancer chemotherapy; cancer patient; cancer recurrence; cancer survival; clinical effectiveness; clinical trial (topic); creatinine clearance; deep vein thrombosis; drug dose reduction; drug withdrawal; febrile neutropenia; human; infection; low drug dose; lung embolism; major clinical study; moderate renal impairment; multiple myeloma; neutropenia; overall survival; patient safety; peripheral neuropathy; pneumonia; priority journal; progression free survival; thrombocytopenia; treatment duration; treatment response; analogs and derivatives; cancer staging; complication; drug resistance; female; kidney failure; male; middle aged; multiple myeloma; pathology; pathophysiology; recurrent disease; retreatment; treatment outcome; very elderly, Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Drug Resistance, Neoplasm; Female; Humans; Male; Middle Aged; Multiple Myeloma; Neoplasm Staging; Recurrence; Renal Insufficiency; Retreatment; Thalidomide; Treatment Outcome
DOI:
10.1080/10428194.2016.1177181
