NCT03941860 · OUTCOME

To Determine the Extent and Timing of Neuropathy Associated With the Addition of Ixazomib to Lenalidomide Maintenance on Patient Reported Health-related Quality of Life (QOL) Outcomes.

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

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Assessed at baseline, end of every 3 cycles for the first 24 cycles, every 6 cycles thereafter up to completion of 48 cycles, and at treatment discontinuation prior to completing 48 cycles. During long-term follow-up, 4 quarterly assessments for 1 year.

What was measured

Health-related QOL will be assessed with three instruments: 1) the FACT-General (G) functional well-being (FWB) and physical wellbeing (PWB) subscales. Each FACT-G subscale has 7 items. The 14 items are based on a 5-point Likert scale (0-4) resulting in a score ranging from 0 to 56 points with a higher score indicating better health-related QOL; 2) The FACT/GOG-Neurotoxicity Trial Outcomes Index (FACT/GOG-Ntx TOI) comprised of the FWB and PWB subscales plus the neurotoxicity subscale which has 11 items, summing to a score of 0-100; and 3) the FACT-Multiple Myeloma Trial Outcomes Index (FACT-MM TOI) comprised of the FWB and PWB subscales plus the multiple myeloma subscale which has 14 items, summing to a score of 0-112 for the instrument.

Groups in this outcome

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

Reported measurements

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

Complete source fields

denom Units Selected: Participants
description: Health-related QOL will be assessed with three instruments: 1) the FACT-General (G) functional well-being (FWB) and physical wellbeing (PWB) subscales. Each FACT-G subscale has 7 items. The 14 items are based on a 5-point Likert scale (0-4) resulting in a score ranging from 0 to 56 points with a higher score indicating better health-related QOL; 2) The FACT/GOG-Neurotoxicity Trial Outcomes Index (FACT/GOG-Ntx TOI) comprised of the FWB and PWB subscales plus the neurotoxicity subscale which has 11 items, summing to a score of 0-100; and 3) the FACT-Multiple Myeloma Trial Outcomes Index (FACT-MM TOI) comprised of the FWB and PWB subscales plus the multiple myeloma subscale which has 14 items, summing to a score of 0-112 for the instrument.
reporting Status: NOT_POSTED
time Frame: Assessed at baseline, end of every 3 cycles for the first 24 cycles, every 6 cycles thereafter up to completion of 48 cycles, and at treatment discontinuation prior to completing 48 cycles. During long-term follow-up, 4 quarterly assessments for 1 year.
title: To Determine the Extent and Timing of Neuropathy Associated With the Addition of Ixazomib to Lenalidomide Maintenance on Patient Reported Health-related Quality of Life (QOL) Outcomes.
type: OTHER_PRE_SPECIFIED

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Preserved source evidence · Not medical advice