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NCT03837509 · OUTCOME

Overall Survival

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
NUMBER
Unit
days
Interval / dispersion
Not reported
Time frame
up to 923 days (approximately 2.5 years)

What was measured

Overall survival was defined as the time from the first dose of study drug to death from any cause until study completion.

Analysis population: Full Analysis Population. As a result of an early-termination decision following a recruitment challenge (no safety-related concerns), a formal analysis was not performed due to an insufficient number of participants enrolled in Phase 2. Overall survival was calculated for individual participants, but data were not formally analyzed.

Groups in this outcome

Phase 1: INCB001158 75 mg BID + Daratumumab

In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (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 1: 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: 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

GroupSource count
Phase 1: INCB001158 75 mg BID + Daratumumab6
Phase 1: INCB001158 100 mg BID + Daratumumab4
Phase 2: INCB001158 100 mg BID + Daratumumab1
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab2
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab1

Reported measurements

Minimum value, uncensored
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: INCB001158 75 mg BID + Daratumumab113Not reportedNot reportedNot reportedNot reported
Phase 1: INCB001158 100 mg BID + Daratumumab127Not reportedNot reportedNot reportedNot reported
Phase 2: INCB001158 100 mg BID + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Maximum value, uncensored
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: INCB001158 75 mg BID + Daratumumab766Not reportedNot reportedNot reportedNot reported
Phase 1: INCB001158 100 mg BID + Daratumumab604Not reportedNot reportedNot reportedNot reported
Phase 2: INCB001158 100 mg BID + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + DaratumumabNANot reportedNot reportedNot reportedMinimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        113
      2. group Id
        OG001
        value
        127
      3. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG002
        value
        NA
      4. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG003
        value
        NA
      5. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG004
        value
        NA
    title
    Minimum value, uncensored
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        766
      2. group Id
        OG001
        value
        604
      3. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG002
        value
        NA
      4. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG003
        value
        NA
      5. comment
        Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
        group Id
        OG004
        value
        NA
    title
    Maximum value, uncensored
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      1
    units
    Participants
description
Overall survival was defined as the time from the first dose of study drug to death from any cause until study completion.
groups
  1. description
    In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (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 1: INCB001158 75 mg BID + Daratumumab
  2. 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
    OG001
    title
    Phase 1: INCB001158 100 mg BID + Daratumumab
  3. 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
    OG002
    title
    Phase 2: INCB001158 100 mg BID + Daratumumab
  4. 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
    OG003
    title
    Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab
  5. 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
    OG004
    title
    Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab
param Type
NUMBER
population Description
Full Analysis Population. As a result of an early-termination decision following a recruitment challenge (no safety-related concerns), a formal analysis was not performed due to an insufficient number of participants enrolled in Phase 2. Overall survival was calculated for individual participants, but data were not formally analyzed.
reporting Status
POSTED
time Frame
up to 923 days (approximately 2.5 years)
title
Overall Survival
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice