NCT05014412 · OUTCOME

Duration of Complete Response Rate (DOCR) 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

DOCR was defined as the time from the first documentation of sCR or CR that was subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i).

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: DOCR was defined as the time from the first documentation of sCR or CR that was subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurred first. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio \<=4:1 or \>=1:2 for κ and λ participants, respectively, after counting \>=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i).
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 Complete Response Rate (DOCR) Per IMWG Response Criteria as Determined by Investigator: Parts 1 and 2
type: SECONDARY

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