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NCT02002598 · OUTCOME

Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone

Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma · Source last updated 2024-09-19

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
6 months

What was measured

MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.

Analysis population: A total of 19 out of 19 participants were analyzed when evaluating the maximum tolerated dose. Participants who received dose level 5 continued to be evaluated for dose limiting toxicities.

Groups in this outcome

CFZ With Bendamustine and Dexamethasone

All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.

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

Analysis denominator · Participants

GroupSource count
CFZ With Bendamustine and Dexamethasone19

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CFZ With Bendamustine and Dexamethasone56Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
groups
  1. description
    All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
    id
    OG000
    title
    CFZ With Bendamustine and Dexamethasone
param Type
NUMBER
population Description
A total of 19 out of 19 participants were analyzed when evaluating the maximum tolerated dose. Participants who received dose level 5 continued to be evaluated for dose limiting toxicities.
reporting Status
POSTED
time Frame
6 months
title
Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice