NCT05014412 · OUTCOME

Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment · Source last updated 2026-02-10

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: Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months)

What was measured

DOR: time from the first documentation of objective response, until confirmed PD, or death due to any cause, whichever occurred first. PD: Increase of \>=25% from lowest confirmed response value in any 1 or more of following: serum M-component (absolute increase must be \>=0.5 g/dL); serum M-protein increase \>=1 g/dL, if lowest M component was \>=5 g/dL; urine M-protein (absolute increase must be \>=200 mg/24 h). In participants without measurable serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (absolute increase must be \>10 mg/dL). In participants without measurable serum, urine M-protein levels and involved serum FLC levels, BM plasma-cell % irrespective of baseline status (must be \>=10%). Appearance of a new lesion, \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of a previous lesion \>1 cm in short axis. \>=50% increase in circulating plasma cells (minimum of 200 cells per mcL) if only measure of disease.

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

anticipated Posting Date: 2026-10
denom Units Selected: Participants
description: DOR: time from the first documentation of objective response, until confirmed PD, or death due to any cause, whichever occurred first. PD: Increase of \>=25% from lowest confirmed response value in any 1 or more of following: serum M-component (absolute increase must be \>=0.5 g/dL); serum M-protein increase \>=1 g/dL, if lowest M component was \>=5 g/dL; urine M-protein (absolute increase must be \>=200 mg/24 h). In participants without measurable serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (absolute increase must be \>10 mg/dL). In participants without measurable serum, urine M-protein levels and involved serum FLC levels, BM plasma-cell % irrespective of baseline status (must be \>=10%). Appearance of a new lesion, \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of a previous lesion \>1 cm in short axis. \>=50% increase in circulating plasma cells (minimum of 200 cells per mcL) if only measure of disease.
reporting Status: NOT_POSTED
time Frame: Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months)
title: Duration of Response (DOR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2
type: SECONDARY

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Preserved source evidence · Not medical advice