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Pr Thierry Facon: Breakthrough in Multiple Myeloma

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Pr Thierry Facon: Breakthrough in Multiple Myeloma

at the 2013 ASH meeting

 

 

Clementine Wallace

A major event at the ASH : the study led by the French Myeloma Intergroup was presented during the plenary session.

With this study comes a milestone in the treatment of myeloma in elderly patients.

 

Thierry Facon

We established some years ago melphalan-prednisone-thalidomide as the standard for care of myeloma patients. We did that five to ten years ago, and based on an IFM study, this regimen was approuved in the EU.

 

After that, we took this very strong controlled arm and we investigate the efficacy and the safety of lenalidomide in combination with low dose dexametasone and basically, the conclusion of that study, which is a huge study in myeloma : 1623 patients, so that is the largest study ever done for registration in myeloma. We have approximatelly 1000 patients recieving lenalidomide and low dose DEX in that study.

 

And basically, we were able to show that lenalidomide and low dose DEX is a better regimen than MPT for Progression-Free Survival, for all other secondary end-points you can have in this kind of study, for Overall Survival as well.

 

And in terms of safety, in fact the safety profile of this regimen is basically good. So, it’s totally in line with what we know from the safety rofile of lenalidomide and DEX because this combination is used in relapsed myeloma.

So this is a very managable regimen.

 

And the good news is also that the incidence of Second Primary Malignancy, and especially hematological Secondary Primary Malignancies, was extremely low with lenalidomide and low dose DEX, and as you know, we got some SPM in the past in some lenalidomide studies. So the regimen is manageable. The regimen is safe and the regimen is associated with better efficacy results.

 

It has to be a new standard of care for the transplant ineligible patients, but, as you know, the registration decision is not…will be the decision of colleagues in regulatory agencies, but as an hematologist I would say it is a new standard of care for myeloma patients.

 

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