Participant flow

Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial · Source last updated 2025-05-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients receive lenalidomide PO QD on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspirate: Undergo bone marrow aspirate Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT scan Ixazomib Citrate: Given PO Lenalidomide: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

   id

   FG000

   title

   Arm A (Lenalidomide, Ixazomib Citrate)

2. description

   Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspirate: Undergo bone marrow aspirate Bone Marrow Biopsy: Undergo bone marrow biopsy Computed Tomography: Undergo CT scan Lenalidomide: Given PO Placebo Administration: Given PO Positron Emission Tomography: Undergo PET scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

   id

   FG001

   title

   Arm B (Lenalidomide, Placebo)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was activated on June 1, 2021 and closed to accrual on March 3, 2023 due to slow accrual.

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Preserved source evidence · Not medical advice