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We hypothesized that flavopiridol treatment could adequately de\u2010bulk disease prior to lenalidomide therapy, decreasing the incidence of tumor flare with higher doses of lenalidomide. In this Phase I study, the maximum tolerated dose was not reached with treatment consisting of flavopiridol 30 mg\u00a0m<jats:sup>\u22122<\/jats:sup> intravenous bolus (IVB)\u2009+\u200930 mg\u00a0m<jats:sup>\u22122<\/jats:sup> continuous intravenous infusion (CIVI) cycle (C) 1 day (D) 1 and 30 mg\u00a0m<jats:sup>\u22122<\/jats:sup> IVB\u2009+\u200950 mg\u00a0m<jats:sup>\u22122<\/jats:sup> CIVI C1 D8,15 and C2\u20108 D3,10,17 with lenalidomide 15 mg orally daily C2\u20108 D1\u201021. There was no unexpected toxicity seen, including no increased tumor lysis, tumor flare (even at higher doses of lenalidomide) or opportunistic infection. Significant clinical activity was demonstrated, with a 51% response rate in this group of heavily pretreated patients. Biomarker testing confirmed association of mitochondrial priming of the BH3 only peptide Puma with response.Am. J. 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