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Site for EAA171 Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM) (21-114)
The purpose of this study is to compare using lenalidomide and ixazomib to using lenalidomide and placebo
Patient will either get lenalidomide and the study drug called ixazomib, or lenalidomide and a placebo. The doctor will continue to follow your condition for up to 10 years.
All
18 year(s) or older
NCT03941860
SITE00001088
Inclusion Criteria:
Patient must be > 18 years of agePatient must be able to undergo a diagnostic bone marrow aspirate following registration to Step 0.
Patient must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational.
Patient must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements
Patient must have been able to maintain at least 10 mg dose of lenalidomide without growth factor support.
Exclusion Criteria:
Patients who have a Grade 2 or higher diarrhea per CTCAE in the absence of antidiarrheals.Patient who have uncontrolled intercurrent illness.
Patients who have Grade 2 or higher peripheral neuropathy or grade 1 peripheral neuropathy with pain per CTCAE.
Women who are pregnant due to potential harm to the fetus from ixazomib and lenalidomide.
Patients who are on other concurrent chemotherapy, or any ancillary therapy considered investigational.
Cancer