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NCT05590377 · OUTCOME

Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Phase 1: Cycle 1 (cycle length=28 days)

What was measured

DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.

Analysis population: The Dose Limiting Toxicity (DLT)-evaluable Population included all participants from the Phase 1 dose escalation portion who experienced a DLT in Cycle 1 in the treatment phase of the study or had completed the Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of daratumumab SC.

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.

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

Analysis denominator · Participants

GroupSource count
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab3
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab6
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab0Not reportedNot reportedNot reportedNot reported
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab0Not reportedNot reportedNot reportedNot reported
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.
groups
  1. 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
  2. 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
  3. 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
param Type
COUNT_OF_PARTICIPANTS
population Description
The Dose Limiting Toxicity (DLT)-evaluable Population included all participants from the Phase 1 dose escalation portion who experienced a DLT in Cycle 1 in the treatment phase of the study or had completed the Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of daratumumab SC.
reporting Status
POSTED
time Frame
Phase 1: Cycle 1 (cycle length=28 days)
title
Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice