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

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

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.

Conflict of interest statement

Mikhael—research funding from Abbvie, Celgene, and Sanofi

Figures

Fig. 1
Fig. 1
Disposition of cases
Fig. 2
Fig. 2
Progression-free survival
Fig. 3
Fig. 3
Overall survival

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