Abstract

Background

Lenalidomide is an effective agent for the treatment of multiple myeloma (MM). The IFM Group conducted a randomized double-blind placebo controlled trial investigating the efficacy of lenalidomide maintenance treatment after autologous transplantation (IFM 2005-02 trial). The results showed that lenalidomide maintenance therapy significantly prolonged progression-free survival (PFS).

Methods

The aim of the present study was to identify prognostic factors affecting PFS in the 614 patients enrolled in this study. Analysis was performed using an extended Cox model, complete response (CR) was entered into the model as a time varying covariate.

Results

With a median follow-up of 60.6 months (54.5-68) PFS since randomization was shorter in the placebo arm (23.8 months, 95% CI 21-27.3) than in the lenalidomide arm (45.6 months, 95% CI: 40-55.1) (p<.001). Multivariate analysis showed that lenalidomide maintenance treatment arm, female sex, and obtention of CR were favourable prognostic factors for PFS. Conversely, beta2microglobuline, deletion of chromosome 13 and induction treatment reinforced by DCEP were associated with reduced PFS. For patients not in CR before initiation of maintenance therapy lenalidomide arm improved significantly PFS. This advantage is still observed in the 129 patients in CR at time of initiation of maintenance treatment.

Conclusion

These results confirm that obtention of CR at any time during treatment is a major factor for improving PFS in MM patients receiving first-line treatment including autologous transplantation. In this setting our data and those of other studies seems to support that lenalidomide maintenance treatment could be an intereresting option for delaying progression. At this time the gain in PFS did not translate into an OS improvement

Disclosures:

Marit:janssen-cilag: Honoraria, upport for travel to meeting, meeting expenses, upport for travel to meeting, meeting expenses Other; celgene: support for travel to meeting, meeting expenses Other. Off Label Use: lenalidomide maintenance treatment after autologous transplantation in myeloma patients. Facon:Amgen: Membership on an entity’s Board of Directors or advisory committees; Britsol-Myers Squibb: Membership on an entity’s Board of Directors or advisory committees; Onyx: Membership on an entity’s Board of Directors or advisory committees; Millennium: The Takeda Oncology Company: Membership on an entity’s Board of Directors or advisory committees; Celgene: Membership on an entity’s Board of Directors or advisory committees; Janssen: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees. Hulin:JANSSEN: Honoraria; CELGENE: Honoraria. Moreau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Roussel:JANSSEN: Honoraria; CELGENE: Honoraria. Avet-Loiseau:JANSSEN: Honoraria, Speakers Bureau; CELGENE: Honoraria, Speakers Bureau. Attal:CELGENE: Honoraria, Speakers Bureau; JANSSEN: Honoraria, Speakers Bureau.

Author notes

*

Asterisk with author names denotes non-ASH members.