Principal Investigator: Faith Davies, M.D.
ClinicalTrials.gov Identifier: NCT02578121
The primary objective is to determine the efficacy of ixazomib when combined with pomalidomide and dexamethasone, in terms of overall response rate in patients with relapsed myeloma. Previous studies have shown that the combination of ixazomib, lenalidomide and dexamethasone had a VGPR (very good partial response rate) of over 60 percent in newly diagnosed myeloma patients, suggesting that the combination of an oral proteasome inhibitor with an IMiD is an effective treatment modality. This single arm Phase II study is designed to build on that data in order to develop an effective oral regimen which is well-tolerated for patients with relapsed disease. The long-term aim is to develop a backbone regimen to which future novel targeted treatments can be added as part of a personalized medicine approach.
A Randomized Phase II Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Myeloma
Principal Investigator: Gareth Morgan, M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT02316106
The purpose of this study is to evaluate three daratumumab dose schedules in participants with smoldering myeloma.
It is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in patients with intermediate or high-risk smoldering myeloma.
Primary outcome measures include:
• Percentage of participants who achieve a complete response.
• Percentage of participants who have an
adverse event per patient-year.*
Secondary outcome measures include:
• Percentage of participants who are minimal residual disease negative.
• Percentage of participants who achieve a complete response or partial response.
• Median time of progression free survival.
• Percentage of participants with symptomatic myeloma.
• Overall survival rate.
*The concept of patient-years is used in many clinical studies and statistical assessments of risk. It enables researchers to look at a population more generally, rather than trying to separate out and process data from each individual member of a group. To obtain the number, researchers add together all of the years that patients in a study were followed, and then divide those years by the event of interest.