A Phase I/II Study of Pomalidomide and Dexamethasone with Growth Factor Support in Patients with Relapsed/Refractory Multiple Myeloma
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with dexamethasone and neupogen (filgrastim) to patients with relapsed or refractory MM. The goal of Part 2 of this study is to learn if the drug combination can help to control MM. The safety of this drug combination will be studied in both parts.
Treatment Location: N/A
Primary Objective Phase I: To determine the maximum tolerated dose (MTD) of pomalidomide and dexamethasone when given with growth factor support in patients with relapsed and refractory multiple myeloma. Phase II: To evaluate the safety of pomalidomide and dexamethasone at the MTD. Secondary Objectives To obtain preliminary estimates of the anti-myeloma activity of higher doses of pomalidomide given with low dose dexamethasone and growth factor support in patients with relapsed and refractory multiple myeloma. Activity will be defined by the overall response rate (ORR) (partial response (PR) or better) and clinical benefit response (CBR) rate (minor response (MR) or better), as well as by the response durability (duration of response (DOR), progression-free survival (PFS), and time to progression (TTP). To further evaluate the safety of pomalidomide and dexamethasone at the maximum tolerated dose (MTD). Exploratory Objectives To examine the influence of Cereblon expression and activation of the Wnt/beta-catenin pathway on the activity of high dose pomalidomide with low dose dexamethasone.
IRB Review and Approval Date: 03/05/2014
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
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