NCT05556616 · OUTCOME

Duration of Response (DOR)

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma · Source last updated 2026-01-29

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: Up to 16.7 months

What was measured

DOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

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: DOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
reporting Status: NOT_POSTED
time Frame: Up to 16.7 months
title: Duration of Response (DOR)
type: SECONDARY

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Preserved source evidence · Not medical advice