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Protocol Summary


Protocol No.
PSCI-21-114
Prinicipal Investigator
Rakszawski, Kevin
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EAA171
Title
Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)
Objective
Primary Objective
To determine whether escalating maintenance therapy with the addition of ixazomib to lenalidomide improves overall survival among patients who are MRD positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (≤ 12 months from diagnosis).

Secondary Clinical Objectives
To establish whether progression-free survival is superior with the addition of ixazomib to lenalidomide maintenance.
To evaluate best response on treatment and compare response rates between arms.
To evaluate the safety profile of ixazomib added to lenalidomide and compare toxicity rates between arms.
Applicable Disease Sites
Multiple Myeloma
Status
Open
Participating Institutions
Hershey Medical Center