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

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 2010 Abstract: 807 Reviewed by: Dr. Tom Kouroukis Date posted: Jul 2 2010.

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

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  1. 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 2010 Abstract: 807 Reviewed by: Dr. Tom Kouroukis Date posted: Jul 2 2010

  2. 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.

  3. 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

  4. 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 McCarthy et al., ASCO 2010, abstract 8017

  5. 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 McCarthy et al., ASCO 2010, abstract 8017

  6. 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

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