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NCT03117361 · OUTCOME

Overall Response

Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide · Source last updated 2020-12-02

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 the date of first drug administration to the date of at least one disease assessment, up to 100 weeks

What was measured

Partial response (PR): ≥50% reduction in serum M-protein and reduction of 24-hour urine M-protein by 90% or to \<200 mg/24h Minimal response (MR): ≥25% but ≤49% reduction of serum M-protein and reduction of 24h urine M-protein 50-89%. Progressive disease (PD): 25% increase from the lowest response value in any of the following: serum M-protein, urine M-protein, BM plasma cell percentage, or difference in the kappa and lambda FLC. PD also diagnosed when an increase size or new bone lesions Stable disease (SD): not meet the criteria for PR, MR or PD Primary analysis should have been done once a total of 64 patients have received plitidepsin+BTZ+DXM with one futility analysis planned after the inclusion of 20 evaluable patients that had completed two full treatment cycles. Only 10 patients were treatedand 8 evaluable for the primary endpoint (ORR according to IMWG criteria). As a result of slow patient accrual, the study was closed before reaching the target enrollment

Analysis population: 1 died without any valid tumor assessment done 1 discontinued treatment-related AEs

Groups in this outcome

Experimental

Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.

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

Analysis denominator · Participants

GroupSource count
Experimental8

Reported measurements

Source class 1

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental1Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental1Not reportedNot reportedNot reportedNot reported

SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental5Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      PR
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      MR
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      SD
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      PD
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Partial response (PR): ≥50% reduction in serum M-protein and reduction of 24-hour urine M-protein by 90% or to \<200 mg/24h Minimal response (MR): ≥25% but ≤49% reduction of serum M-protein and reduction of 24h urine M-protein 50-89%. Progressive disease (PD): 25% increase from the lowest response value in any of the following: serum M-protein, urine M-protein, BM plasma cell percentage, or difference in the kappa and lambda FLC. PD also diagnosed when an increase size or new bone lesions Stable disease (SD): not meet the criteria for PR, MR or PD Primary analysis should have been done once a total of 64 patients have received plitidepsin+BTZ+DXM with one futility analysis planned after the inclusion of 20 evaluable patients that had completed two full treatment cycles. Only 10 patients were treatedand 8 evaluable for the primary endpoint (ORR according to IMWG criteria). As a result of slow patient accrual, the study was closed before reaching the target enrollment
groups
  1. description
    Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
    id
    OG000
    title
    Experimental
param Type
COUNT_OF_PARTICIPANTS
population Description
1 died without any valid tumor assessment done 1 discontinued treatment-related AEs
reporting Status
POSTED
time Frame
From the date of first drug administration to the date of at least one disease assessment, up to 100 weeks
title
Overall Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice