Skip to content
← Full study record

NCT03941860 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      0
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm B (Lenalidomide, Placebo)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. title
    Age, Continuous
  2. classes
    1. categories
      1. title
        Female
      2. title
        Male
    title
    Sex: Female, Male
  3. classes
    1. categories
      1. title
        Hispanic or Latino
      2. title
        Not Hispanic or Latino
      3. title
        Unknown or Not Reported
    title
    Ethnicity (NIH/OMB)
  4. classes
    1. categories
      1. title
        American Indian or Alaska Native
      2. title
        Asian
      3. title
        Native Hawaiian or Other Pacific Islander
      4. title
        Black or African American
      5. title
        White
      6. title
        More than one race
      7. title
        Unknown or Not Reported
    title
    Race (NIH/OMB)
population Description
Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data is not reported.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      0
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm B (Lenalidomide, Placebo)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. title
    Age, Continuous
  2. classes
    1. categories
      1. title
        Female
      2. title
        Male
    title
    Sex: Female, Male
  3. classes
    1. categories
      1. title
        Hispanic or Latino
      2. title
        Not Hispanic or Latino
      3. title
        Unknown or Not Reported
    title
    Ethnicity (NIH/OMB)
  4. classes
    1. categories
      1. title
        American Indian or Alaska Native
      2. title
        Asian
      3. title
        Native Hawaiian or Other Pacific Islander
      4. title
        Black or African American
      5. title
        White
      6. title
        More than one race
      7. title
        Unknown or Not Reported
    title
    Race (NIH/OMB)
population Description
Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data is not reported.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice