NCT05590377 · OUTCOME

Phase 2a: Disease Control Rate (DCR)

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Phase 2a: Up to 15.9 months

What was measured

DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.

Analysis population: After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

Groups in this outcome

Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab

Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

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

Analysis denominator · Participants

Group	Source count
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab	0
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab	0

Reported measurements

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

Complete source fields

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants

description

DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.

groups

description
Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
id
OG000
title
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
description
Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
id
OG001
title
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

population Description

After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \& no data was collected for this outcome measure due to study termination.

reporting Status

POSTED

time Frame

Phase 2a: Up to 15.9 months

title

Phase 2a: Disease Control Rate (DCR)

type

SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice