Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials

David S. Siegel, Katja C. Weisel, Meletios A. Dimopoulos, Rachid Baz, Paul Richardson, Michel Delforge, Kevin W. Song, Jesus F. San Miguel, Philippe Moreau, Hartmut Goldschmidt, Michele Cavo, Sundar Jagannath, Xin Yu, Kevin Hong, Lars Sternas, Mohamed Zaki, Antonio Palumbo

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

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).

Original languageEnglish
Pages (from-to)2833-2838
Number of pages6
JournalLeukemia and Lymphoma
Volume57
Issue number12
DOIs
StatePublished - 1 Dec 2016

Keywords

  • IMiD
  • pomalidomide
  • relapsed/refractory multiple myeloma
  • renal impairment

Fingerprint

Dive into the research topics of 'Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials'. Together they form a unique fingerprint.

Cite this