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NCT03941860 · OUTCOME

Best Response on Treatment

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.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Assessed every 3 months if patient is <2 years from randomization, every 6 months if patient is 2-5 years from randomization, annually if patient is 5 years or more from randomization.

What was measured

Response is evaluated based on standard International Myeloma Working Group (IMWG) criteria and tabulated by category. Response (stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\]) is defined as below. sCR: All CR criteria and the following have to be met. Normal serum FLC ratio at two consecutive times and absence of clonal cells in bone marrow by immunohistochemistry or 2- to 4- color flow cytometry. Presence/absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by immunohistochemistry requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting presence of an abnormal clone is κ/λ ratio of 4:1 or 1:2. CR: Complete disappearance of an Mprotein and no evidence of myeloma in the bone marrow. VGPR: Serum M-protein detectable by immunofixation but not quantifiable on electrophoresis and urine M-protein \< 100 mg/24 hours

Analysis population: Only one patient was enrolled on this study. Due to confidentiality reasons, individual data was not reported.

Groups in this outcome

Arm A (Lenalidomide, Ixazomib Citrate)

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

Arm B (Lenalidomide, Placebo)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Lenalidomide, Ixazomib Citrate)0
Arm B (Lenalidomide, Placebo)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Response is evaluated based on standard International Myeloma Working Group (IMWG) criteria and tabulated by category. Response (stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\]) is defined as below. sCR: All CR criteria and the following have to be met. Normal serum FLC ratio at two consecutive times and absence of clonal cells in bone marrow by immunohistochemistry or 2- to 4- color flow cytometry. Presence/absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by immunohistochemistry requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting presence of an abnormal clone is κ/λ ratio of 4:1 or 1:2. CR: Complete disappearance of an Mprotein and no evidence of myeloma in the bone marrow. VGPR: Serum M-protein detectable by immunofixation but not quantifiable on electrophoresis and urine M-protein \< 100 mg/24 hours
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
    OG000
    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
    OG001
    title
    Arm B (Lenalidomide, Placebo)
population Description
Only one patient was enrolled on this study. Due to confidentiality reasons, individual data was not reported.
reporting Status
POSTED
time Frame
Assessed every 3 months if patient is <2 years from randomization, every 6 months if patient is 2-5 years from randomization, annually if patient is 5 years or more from randomization.
title
Best Response on Treatment
type
SECONDARY

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Preserved source evidence · Not medical advice