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NCT02100657 · OUTCOME

Overall Response Rate

Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2020-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years

What was measured

Overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) according to the International Myeloma Working Group (IMWG) criteria

Groups in this outcome

Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)

Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)

Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)

Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

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

Analysis denominator · Participants

GroupSource count
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)7
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)3
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)18

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)57.1Not reported18.490.1Not reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)66.7Not reported9.499.2Not reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)22.2Not reported6.447.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.4
        upper Limit
        90.1
        value
        57.1
      2. group Id
        OG001
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      3. group Id
        OG002
        lower Limit
        6.4
        upper Limit
        47.6
        value
        22.2
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      18
    units
    Participants
description
Overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) according to the International Myeloma Working Group (IMWG) criteria
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG000
    title
    Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)
  2. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG001
    title
    Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  3. description
    Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG002
    title
    Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
param Type
MEAN
reporting Status
POSTED
time Frame
Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
title
Overall Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice