NCT05590377 · OUTCOME

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

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: Up to 15.9 months

What was measured

Duration of MRD negativity for participants achieving MRD negativity is defined as the time from the date of first documentation of MRD negativity to the first documentation of MRD positivity or confirmed progressive disease, whichever occurs first. It will be calculated for participants achieving MRD negativity only. No participants had sCR or CR in Phase 1 thus the overall number of participants analyzed is zero.

Analysis population: Only participants who had a confirmed stringent CR (sCR) or complete response (CR) were to be analyzed for this outcome measure. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. 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 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab

Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 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 or up to 60 weeks.

Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab

Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 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 or up to 48 weeks.

Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab

Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 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 or up to 36 weeks.

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 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab	0
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab	0
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab	0
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
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants

description

groups

description
Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 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 or up to 60 weeks.
id
OG000
title
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
description
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 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 or up to 48 weeks.
id
OG001
title
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
description
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 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 or up to 36 weeks.
id
OG002
title
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
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
OG003
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
OG004
title
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

population Description

Only participants who had a confirmed stringent CR (sCR) or complete response (CR) were to be analyzed for this outcome measure. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. 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

Up to 15.9 months

title

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

type

SECONDARY

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

Preserved source evidence · Not medical advice