Clinical Trial: Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Study Status: Completed
Recruit Status: RECRUITING
Condition: Multiple Myeloma
Study Type: INTERVENTIONAL
Official Title: A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of Multiple Myeloma (MM)
Brief Summary:
Primary Objective• Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI).Secondary ObjectivesTo assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity.To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.To determine pharmacodynamic (PD) changes with…
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