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NCT03151811 · OUTCOME

Overall Response Rate (ORR)

A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide · Source last updated 2024-01-30

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
From randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 Feb 2021 (ie, assessed up to approx. 43 months). Median time to best response: Arm A=2.1 months and Arm B=2.0 months

What was measured

ORR defined as the proportion of patients for whom the best overall confirmed response is stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by IRC.

Analysis population: Full Analysis Set

Groups in this outcome

Arm A: Melflufen+Dexamethasone

Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets

Arm B: Pomalidomide+Dexamethasone

Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets

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

Analysis denominator · Participants

GroupSource count
Arm A: Melflufen+Dexamethasone246
Arm B: Pomalidomide+Dexamethasone249

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Melflufen+Dexamethasone80Not reportedNot reportedNot reportedNot reported
Arm B: Pomalidomide+Dexamethasone67Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        67
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. group Id
      OG001
      value
      249
    units
    Participants
description
ORR defined as the proportion of patients for whom the best overall confirmed response is stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by IRC.
groups
  1. description
    Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Melflufen: Intravenous infusion Dexamethasone: Oral tablets
    id
    OG000
    title
    Arm A: Melflufen+Dexamethasone
  2. description
    Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue. Pomalidomide: Oral capsules Dexamethasone: Oral tablets
    id
    OG001
    title
    Arm B: Pomalidomide+Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
From randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 Feb 2021 (ie, assessed up to approx. 43 months). Median time to best response: Arm A=2.1 months and Arm B=2.0 months
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice