Authors: McCarthy et al., ASCO 2010 Abstract: 807 Reviewed by: Dr. Tom Kouroukis

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ASCO 2010

Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single

autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB 100104

Authors: McCarthy et al., ASCO 2010Abstract: 807Reviewed by: Dr. Tom KouroukisDate posted: Jul 2 2010


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Background

• As per Attal et al, ASCO 2010• This study was designed to see if TTP was improved

post transplant with lenalidomide maintenance• Patients received a standard transplant using high dose

melphalan (200 mg/m2)• Randomized to lenalidomide (10-15 mg/d as tolerated)

or placebo at day 100-110 post transplant

McCarthy et al., ASCO 2010, abstract 8017


CALGB 100104

• 568 patients were enrolled; this analysis is based on 418 randomized patients at the second interim analysis

• Median f/u 12 months• There was a 58% reduction is event risk in the

lenalidomide arm; (HR 0.42, 95%CI 0.27, 0.67)• Estimated median TTP 25.5 months for placebo, not

reached for lenalidomide arm



CALGB 100104

• Improvements in the TTP with lenalidomide were observed regardless of B2M level, prior thalidomide or lenalidomide exposure

• The number of deaths were not significantly different between the two treatment arms

• The adverse event profile appear similar between the two groups

• Conclusions: lenalidomide maintenance at doses of 10-15 mg/day post single autologous stem cell transplant significantly delays TTP without a significant increase in adverse effects



BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• Similar to the Attal abstract, this study confirms the benefits of lenalidomide maintenance post single autologous stem cell transplant

• The F/U time is early in this study at 12 months, longer time is needed

• No comparative data to thalidomide maintenance• It would be helpful to see how many patients in the

placebo group received lenalidomide as treatment at the time of progression: likely many of them, and this will make survival differences difficult to detect

Authors: McCarthy et al., ASCO 2010 Abstract: 807 Reviewed by: Dr. Tom Kouroukis

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