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The combination of dexamethasone and placebo refers specifically to the control arm of the MM-010 (NCT00424047) Phase 3 clinical trial sponsored by Celgene. In this randomized, double-blind study, patients with relapsed or refractory multiple myeloma received either lenalidomide plus dexamethasone or a placebo plus dexamethasone. Dexamethasone is a potent synthetic glucocorticoid and corticosteroid that acts as an anti-inflammatory and immunosuppressive agent. In this trial context, it was administered as high-dose pulse therapy (40 mg) to serve as the standard-of-care comparator against which the efficacy of adding lenalidomide was measured. Dexamethasone exerts its effects by binding to the glucocorticoid receptor, leading to the inhibition of pro-inflammatory cytokine production and the induction of apoptosis in malignant plasma cells.
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