ASCO 2010 Lenalidomide maintenance after transplantation for myeloma (IFM 2005-02 Study)

1. ASCO 2010Lenalidomide maintenance after transplantation for myeloma (IFM 2005-02 Study) Authors: Attal et al, ASCO 2010 Abstract: 8018 Reviewed by: Dr. Tom Kouroukis Date posted: Jul 2 2010

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3. Background Lenalidomide is an active anti-myeloma agent in new diagnosed or relapsed patients; it is more potent than thalidomide Previous studies have shown benefits to thalidomide maintenance post autologous stem cell transplantation in patients with myeloma In Canada, practice has been to suggest thalidomide maintenance following autologous stem cell transplantation in newly diagnosed patients; barrier is typically accessibility via the CANTAP program Lenalidomide is being tested as a maintenance therapy post transplantation Attal et al., ASCO 2010, abstract 8018

4. IFM 2005-02 Study Patients post single autologous transplant for multiple myeloma, age less than 65 years Most patients were treated with induction consisting of VAD or bortezomib/dexamethasone Received consolidation with lenalidomide 25 mg/day x 21 days, monthly for 2 months followed by randomization to either: Lenalidomide 10-15 mg/day until relapse, or Placebo PFS was the main outcome Attal et al., ASCO 2010, abstract 8018

5. IFM 2005-02 Study This abstract represents the first pre-planned interim analysis The DSMB recommended unblinding the study due to superiority of the lenalidomide arm With a median f/u of 24 months, 614 patients were randomized Baseline patient characteristics were similar Attal et al., ASCO 2010, abstract 8018

6. IFM 2005-02 Study Consolidation improved response rate post transplant by 20% 3 year PFS was 68% vs. 35% in favour of lenalidomide maintenance (HR 0.46, P<0.000001) 2 year OS was similar between both arms Conclusions: lenalidomide maintenance post autologous stem cell transplant in myeloma improves PFS Attal et al., ASCO 2010, abstract 8018

7. BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS Currently lenalidomide is approved and funded for use in relapsed myeloma, after at least one prior therapy, in combination with dexamethasone Thalidomide has no official Health Canada approval yet, but has been used through Special Access as maintenance post autologous stem cell transplant in myeloma Thalidomide does have toxicities including neuropathy which may limit its long term use Attal et al., ASCO 2010, abstract 8018

8. BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS Lenalidomide is associated with less neuropathy but can be associated with myelosuppression over time We don’t have comparative data between the two agents in the maintenance setting Lenalidomide, when approved, will be an attractive option for maintenance post transplantation The final report from this study may tell us how many patients in the placebo group crossed over to receive lenalidomide maintenance; and whether there is any data regarding patients who received treatment with lenalidomide for relapse compared to those who received it for maintenance Attal et al., ASCO 2010, abstract 8018