NCT03837509 · OUTCOME

Phase 2: Number of Participants With Any TEAE

INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-11-04

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: up to 420 days

What was measured

A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.

Analysis population: Full Analysis Population

Groups in this outcome

Phase 2: INCB001158 100 mg BID + Daratumumab

In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.

Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab

In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.

Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab

In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.

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 2: INCB001158 100 mg BID + Daratumumab	2
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab	1
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab	2

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2: INCB001158 100 mg BID + Daratumumab	1	Not reported	Not reported	Not reported	Not reported
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab	1	Not reported	Not reported	Not reported	Not reported
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
2
units
Participants

description

A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.

groups

description
In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
id
OG000
title
Phase 2: INCB001158 100 mg BID + Daratumumab
description
In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
id
OG001
title
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
description
In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
id
OG002
title
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab

param Type

COUNT_OF_PARTICIPANTS

population Description

Full Analysis Population

reporting Status

POSTED

time Frame

up to 420 days

title

Phase 2: Number of Participants With Any TEAE

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice