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ASCO 2010Lenalidomide maintenance after

transplantation for myeloma (IFM 2005-02 Study)

Authors: Attal et al, ASCO 2010Abstract: 8018Reviewed by: Dr. Tom KouroukisDate posted: Jul 2 2010

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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

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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

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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

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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

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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

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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