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NCT00784823 · OUTCOME

The Maximum Tolerated Dose of Bortezomib (MTD)

Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma · Source last updated 2022-08-11

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

Measure
NUMBER
Unit
mg/m2 of bortezomib
Interval / dispersion
Not reported
Time frame
During dosing of Bortezomib on Day -4 to Day -1 of ASCT

What was measured

The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT

Groups in this outcome

Combined Dose Intense Melphalan With Bortezomib (MTD)

The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation. Combined dose intense Melphalan with maximum tolerated dose of bortezomib (MTD) Bortezomib: - Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen Melphalan: - Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour * Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration * The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period * Melphalan will be given as a single dose (not split over 2 or more days) * Dosing will be based body surface area calculated using actual body weight

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

Analysis denominator · Participants

GroupSource count
Combined Dose Intense Melphalan With Bortezomib (MTD)32

Reported measurements

Source class 1
Values in mg/m2 of bortezomib · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combined Dose Intense Melphalan With Bortezomib (MTD)1.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
The Maximum Tolerated Dose of Bortezomib (MTD) Will be Defined as the Dose Level Prior to That Resulting in Two Out of Six Patients Experiencing a DLT
groups
  1. description
    The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation. Combined dose intense Melphalan with maximum tolerated dose of bortezomib (MTD) Bortezomib: - Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen Melphalan: - Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour * Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration * The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period * Melphalan will be given as a single dose (not split over 2 or more days) * Dosing will be based body surface area calculated using actual body weight
    id
    OG000
    title
    Combined Dose Intense Melphalan With Bortezomib (MTD)
param Type
NUMBER
reporting Status
POSTED
time Frame
During dosing of Bortezomib on Day -4 to Day -1 of ASCT
title
The Maximum Tolerated Dose of Bortezomib (MTD)
type
PRIMARY
unit Of Measure
mg/m2 of bortezomib

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

Preserved source evidence · Not medical advice