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NCT03941860 · OUTCOME

Progression-free Survival (PFS)

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

Progression-free survival defined as the time from randomization until the earlier of progression or death due to any cause, or censored at date of last disease evaluation. Progression is defined as one of the following criteria is met. * Increase of ≥ 25% from lowest value reported in serum M-component (the absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (the absolute increase must be ≥ 200 mg/ 24 hours). * Only in patients without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL. * If the only measurable disease is bone marrow, bone marrow plasma cell percentage: the absolute % must be ≥ 10%. * Development of new bone lesions or soft tissue plasmacytomas or ≥ 50% increase from nadir in the size (SPD) of existing bone lesions or soft tissue plasmacytoma or ≥ 50% increase in the longest diameter of a previous lesion \> 1cm in short axis.

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
Progression-free survival defined as the time from randomization until the earlier of progression or death due to any cause, or censored at date of last disease evaluation. Progression is defined as one of the following criteria is met. * Increase of ≥ 25% from lowest value reported in serum M-component (the absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (the absolute increase must be ≥ 200 mg/ 24 hours). * Only in patients without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL. * If the only measurable disease is bone marrow, bone marrow plasma cell percentage: the absolute % must be ≥ 10%. * Development of new bone lesions or soft tissue plasmacytomas or ≥ 50% increase from nadir in the size (SPD) of existing bone lesions or soft tissue plasmacytoma or ≥ 50% increase in the longest diameter of a previous lesion \> 1cm in short axis.
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
Progression-free Survival (PFS)
type
SECONDARY

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

Preserved source evidence · Not medical advice