Lenalidomide plus melphalan and prednisone, followed by lenalidomide maintenance (MPR-R) was not superior to melphalan, prednisone, and thalidomide, followed by thalidomide maintenance (MPT-T) in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation, a study published in the journal Blood has shown.1
Although the combination of MPT is considered standard therapy for newly diagnosed patients with multiple myeloma who are not eligible to undergo stem cell transplantation, long-term maintenance treatment with thalidomide is often associated with neurotoxicity. In contrast, MPR-R has shown promising efficacy without causing severe neuropathy.
For the multicenter, open-label, phase 3 trial, researchers enrolled 637 patients and randomly assigned them 1:1 to receive 9 cycles of MPT every 4 weeks followed by thalidomide maintenance until disease progression or unacceptable toxicity or 9 cycles of MPT every 4 weeks followed by lenalidomide maintenance.
Results showed that after a median follow-up of 36 months, progression-free survival was 20 months (95% CI, 18 – 23) with MPT-T compared with 23 months (95% CI,19 – 27) with MPR-R (HR, 0.87; 95% CI, 0.72 – 1.04; P = .12).
Researchers found that response rates between groups were similar, with very good partial responses or better occurring in 47% of the MPT-T group and 45% of the MPR-R group.
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In terms of safety, hematological toxicity was reported more frequently with MPR-R, particularly grade 3 and neutropenia, while grade 3 or worse neuropathy was significantly more common with MPT-T. Grade 3 or worse neuropathy resulted in a significantly shorter duration of maintenance therapy, regardless of age.
“MPR-R has no advantage over MPT-T concerning efficacy,” the authors concluded. “The toxicity profile differed with clinically significant neuropathy during thalidomide maintenance versus myelosuppression with MPR.”
- Zweegman S, van der Holt B, Mellqvist U-H, et al. Lenalidomide plus melphalan and prednisone, followed by lenalidomide maintenance versus thalidomide plus melphalan and prednisone, followed by thalidomide maintenance; results of the randomised phase 3 HOVON 87/NMSG18 trial [published online ahead of print January 22, 2016]. Blood. doi: 10.1182/blood-2015-11-679415.