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NCT03481556 · OUTCOME

Phase 2: Overall Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)

What was measured

ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better.

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

Groups in this outcome

Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone

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.

Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone

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.

Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone

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).

Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone

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
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone15
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone8
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone6
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone27

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone80Not reported51.995.7Not reported
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone75Not reported34.996.8Not reported
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone83.3Not reported35.999.6Not reported
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone70.4Not reported49.886.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.9
        upper Limit
        95.7
        value
        80
      2. group Id
        OG001
        lower Limit
        34.9
        upper Limit
        96.8
        value
        75
      3. group Id
        OG002
        lower Limit
        35.9
        upper Limit
        99.6
        value
        83.3
      4. group Id
        OG003
        lower Limit
        49.8
        upper Limit
        86.2
        value
        70.4
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
ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better.
dispersion Type
95% Confidence Interval
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
    Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
  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
    Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
  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
    Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
  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
    Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
param Type
NUMBER
population Description
All participants included in the Safety Analysis Set were included in this analysis.
reporting Status
POSTED
time Frame
Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
title
Phase 2: Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice