Date of Award

2015

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

Objective: The objective of this selective EBM review is to determine whether or not pomalidomide plus low dose Dexamethasone is an effective and safe treatment for patients with relapsed or refractory multiple myeloma (RRMM).

Study Design: Review of three open-label clinical trials with one published in 2012 and two published in 2013.

Data Sources: Two randomized, open-label, phase 2 clinical trials and one open-label phase 3 clinical trial evaluating efficacy of pomalidomide plus low dose dexamethasone and its safety were found using the PubMed database.

Outcomes Measured: Efficacy of pomalidomide plus low-dose dexamethasone was measured by overall response rates (ORR) to the treatment according to the International Myeloma Working Group Criteria/European Group for Blood and Marrow Transplantation criteria.9,10 Safety profile of the treatment regiment was assessed through measuring ANC looking for neutropenia.

Results: The studies by Richardson, et al. and Miguel et al. found pomalidomide plus low-dose dexamethasone led to an increased number of patients responding to treatment compared to controls as well as decreased cases of neutropenia.3,4 The study by Leleu et. al. found the 28 day cycle of pomalidomide plus weekly 40 mg of dexamethasone with pomalidomide on days 1-21 had a more favorable safety profile for patients compared to pomalidomide on days 1-28.2

Conclusions: Based on analysis of these 3 randomized controlled trials, pomalidomide plus low dose dexamethasone is a safe and effective treatment option for RRMM. The open-label design of these studies warrants further follow-up with patients who are continuing with these studies to further verify the results established in these reviews.

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