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Clinical Trial 19001
Cancer Type: Malignant Hematology
Interventions:CC-5013 (Lenalidomide); CWP232291; Dexamethasone; Lenalidomide (Revlimid)
Study Type: Treatment
Phase of Study: Phase I
A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed or Refractory Myeloma (MM)
The purpose of this study is to examine CWP232291, an investigational drug that may treat relapsed or refractory multiple myeloma (MM).
STUDY OBJECTIVES AND PURPOSE Primary Objective: The primary objective of this study is to determine the recommended Phase 2 dose (RP2D) of CWP232291 for subjects with relapsed or refractory myeloma, when administered either alone (Phase 1a) or in combination with lenalidomide and dexamethasone (Phase 1b). Secondary Objectives: In both Phase 1a and Phase 1b for subjects with MM, the secondary objectives are: To determine the safety and tolerability of each regimen evaluated. To characterize the pharmacokinetic (PK) profile of CWP232291 and CWP232204 administered alone, and in combination with lenalidomide and dexamethasone. To evaluate effects of CWP232291 on relevant biomarkers alone, and in combination with lenalidomide and dexamethasone. To assess the preliminary anticancer efficacy of CWP232291 alone, and in combination with lenalidomide and dexamethasone.