NCT05014412 · OUTCOME

Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria: 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

MRD negativity rate was defined as the percentage of participants with negative MRD (assessed by central laboratory) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first. Sequencing MRD negative included: 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as \<2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10\^5 nucleated cells.

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: MRD negativity rate was defined as the percentage of participants with negative MRD (assessed by central laboratory) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first. Sequencing MRD negative included: 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as \<2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10\^5 nucleated cells.
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: Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria: Parts 1 and 2
type: SECONDARY

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