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NCT02100657 · OUTCOME

Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib

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
NUMBER
Unit
mg of dexamethasone
Interval / dispersion
Not reported
Time frame
After 28-day cycle

What was measured

To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.

Analysis population: Participants who received at least 1 dose study treatment

Groups in this outcome

All Participants

All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM

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

Analysis denominator · Participants

GroupSource count
All Participants18

Reported measurements

Source class 1
Values in mg of dexamethasone · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants40.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        40.0
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.
groups
  1. description
    All participants who received at least 1 dose of plitidepsin as a 3-hour i.v. infusion on Days 1 and 15 in combination with BTZ administered s.c. on Days 1, 4, 8 and 11, and DXM orally on Days 1, 8, 15 and 22 q4wk in patients with relapsed and/or refractory MM
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
Participants who received at least 1 dose study treatment
reporting Status
POSTED
time Frame
After 28-day cycle
title
Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib
type
PRIMARY
unit Of Measure
mg of dexamethasone

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

Preserved source evidence · Not medical advice