Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study

Joseph R Mikhael, Judith Manola, Amylou Dueck, Suzanne Hayman, Kurt Oettel, Abraham S. Kanate, Sagar Lonial, S Vincent Rajkumar

Research output: Contribution to journalArticle

Abstract

Renal insufficiency is common in patients with relapsed multiple myeloma and can often limit choice of therapy. Lenalidomide, a critical agent in the treatment of relapsed multiple myeloma, is renally cleared., This phase I/II trial evaluated the efficacy and safety of lenalidomide with dexamethasone in patients with relapsed multiple myeloma and renal insufficiency. Three groups were treated, with creatinine clearance 30–60 cc/hr (group A), CrCl < 30 not on dialysis (group B), and patients on dialysis (group C) at escalating doses of lenalidomide. A total of 63 patients were treated and no DLTs were observed in phase I. All three groups were able to escalate to full dose lenalidomide 25 mg daily 21/28 days, although due to reduced accrual the phase II component was not entirely completed for groups B and C. Adverse events were as expected, including anemia, diarrhea and fatigue. Ten patients experienced grade 3–4 pneumonia. Overall response rate was 54% across all groups. PFS was 7.5 months and OS was 19.7 months. Lenalidomide can be given at full dose 25 mg daily 21/28 in patients with a CrCl > 30, and can be given daily to those with CrCl < 30, even when on dialysis, at doses of at least 15 mg daily.

Original languageEnglish (US)
Article number86
JournalBlood Cancer Journal
Volume8
Issue number9
DOIs
StatePublished - Sep 1 2018

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Multiple Myeloma
Dexamethasone
Kidney
Renal Insufficiency
Dialysis
Creatinine
Safety
Therapeutics
lenalidomide

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function : PrE1003, a PrECOG study. / Mikhael, Joseph R; Manola, Judith; Dueck, Amylou; Hayman, Suzanne; Oettel, Kurt; Kanate, Abraham S.; Lonial, Sagar; Rajkumar, S Vincent.

In: Blood Cancer Journal, Vol. 8, No. 9, 86, 01.09.2018.

Research output: Contribution to journalArticle

Mikhael, Joseph R ; Manola, Judith ; Dueck, Amylou ; Hayman, Suzanne ; Oettel, Kurt ; Kanate, Abraham S. ; Lonial, Sagar ; Rajkumar, S Vincent. / Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function : PrE1003, a PrECOG study. In: Blood Cancer Journal. 2018 ; Vol. 8, No. 9.
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