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NCT02100657 · OUTCOME

Response According to International Myeloma Working Group Criteria

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years

What was measured

Stringent complete response (sCR) normal Free Light Chains (FLC) ratio. No clonal cells Complete response (CR) no serum/urine M-protein, no evidence of soft tissue plasmacytoma. \<5% clonal plasma cells Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL

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

sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported

VGPR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)2Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)2Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported

SD≥4 months

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)2Not reportedNot reportedNot reportedNot reported

SD<4 months

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)7Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)1Not reportedNot reportedNot reportedNot reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)0Not reportedNot reportedNot reportedNot reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      title
      sCR
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      title
      CR
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      title
      VGPR
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      title
      PR
    5. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      title
      MR
    6. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      title
      SD≥4 months
    7. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        7
      title
      SD<4 months
    8. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      title
      PD
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      18
    units
    Participants
description
Stringent complete response (sCR) normal Free Light Chains (FLC) ratio. No clonal cells Complete response (CR) no serum/urine M-protein, no evidence of soft tissue plasmacytoma. \<5% clonal plasma cells Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
title
Response According to International Myeloma Working Group Criteria
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice