Asco 2010 lenalidomide maintenance after transplantation for myeloma ifm 2005 02 study
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ASCO 2010 Lenalidomide 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. Thank you for downloading this update. Please feel free to use it for educational purposes.

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

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Asco 2010 lenalidomide maintenance after transplantation for myeloma ifm 2005 02 study

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


Asco 2010 lenalidomide maintenance after transplantation for myeloma ifm 2005 02 study

Thank you for downloading this update. Please feel free to use it for educational purposes.

Please acknowledge OncologyEducation.ca and Dr. Kouroukis when using these slides.


Background

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


Ifm 2005 02 study

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


Ifm 2005 02 study1

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


Ifm 2005 02 study2

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


Bottom line for canadian medical oncologists

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


Bottom line for canadian medical oncologists1

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


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