Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03481556 · OUTCOME

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM · Source last updated 2022-12-19

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
Cycle 1 Day 1 up to a maximum of 198.9 weeks

What was measured

TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered.

Analysis population: Only participants included in the Safety Analysis Set were included in this analysis.

Groups in this outcome

A (Melflufen+Bortezomib+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

A (Melflufen+Bortezomib+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

B (Melflufen+Daratumumab+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

B (Melflufen+Daratumumab+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

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

Analysis denominator · Participants

GroupSource count
A (Melflufen+Bortezomib+Dex) 30 mg15
A (Melflufen+Bortezomib+Dex) 40 mg8
B (Melflufen+Daratumumab+Dex) 30 mg6
B (Melflufen+Daratumumab+Dex) 40 mg27

Reported measurements

Any TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A (Melflufen+Bortezomib+Dex) 30 mg15Not reportedNot reportedNot reportedNot reported
A (Melflufen+Bortezomib+Dex) 40 mg8Not reportedNot reportedNot reportedNot reported
B (Melflufen+Daratumumab+Dex) 30 mg6Not reportedNot reportedNot reportedNot reported
B (Melflufen+Daratumumab+Dex) 40 mg27Not reportedNot reportedNot reportedNot reported
Any Grade 3 or Higher TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A (Melflufen+Bortezomib+Dex) 30 mg15Not reportedNot reportedNot reportedNot reported
A (Melflufen+Bortezomib+Dex) 40 mg8Not reportedNot reportedNot reportedNot reported
B (Melflufen+Daratumumab+Dex) 30 mg6Not reportedNot reportedNot reportedNot reported
B (Melflufen+Daratumumab+Dex) 40 mg26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        27
    title
    Any TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        26
    title
    Any Grade 3 or Higher TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      27
    units
    Participants
description
TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered.
groups
  1. description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    A (Melflufen+Bortezomib+Dex) 30 mg
  2. description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    OG001
    title
    A (Melflufen+Bortezomib+Dex) 40 mg
  3. description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    OG002
    title
    B (Melflufen+Daratumumab+Dex) 30 mg
  4. description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    OG003
    title
    B (Melflufen+Daratumumab+Dex) 40 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Only participants included in the Safety Analysis Set were included in this analysis.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 up to a maximum of 198.9 weeks
title
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice