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NCT01177683 · OUTCOME

Phase I & Phase II : Toxicity of Treatment Regimen

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma · Source last updated 2023-10-06

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 C1D1 until death or up to a maximum of 54 months

What was measured

Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined.

Analysis population: Two subjects in phase II never received treatment. Therefore, they were not included in any assessment of objectives.

Groups in this outcome

Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.

Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.

Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.

Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.

Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.

Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.24

Reported measurements

Number of patients had at least one adverse event of any grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3Not reportedNot reportedNot reportedNot reported
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3Not reportedNot reportedNot reportedNot reported
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.24Not reportedNot reportedNot reportedNot reported
Number of patients had at least one grade 3 or greater adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.2Not reportedNot reportedNot reportedNot reported
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3Not reportedNot reportedNot reportedNot reported
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.19Not reportedNot reportedNot reportedNot reported
Number of patients had at least one grade 3 or greater treatment related adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.2Not reportedNot reportedNot reportedNot reported
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.3Not reportedNot reportedNot reportedNot reported
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.14Not reportedNot reportedNot reportedNot reported
Number of patients having serious adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.1Not reportedNot reportedNot reportedNot reported
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.1Not reportedNot reportedNot reportedNot reported
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        24
    title
    Number of patients had at least one adverse event of any grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        19
    title
    Number of patients had at least one grade 3 or greater adverse event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        14
    title
    Number of patients had at least one grade 3 or greater treatment related adverse event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        8
    title
    Number of patients having serious adverse event
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined.
groups
  1. description
    Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    OG000
    title
    Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  2. description
    Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    OG001
    title
    Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
  3. description
    Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
    id
    OG002
    title
    Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
param Type
COUNT_OF_PARTICIPANTS
population Description
Two subjects in phase II never received treatment. Therefore, they were not included in any assessment of objectives.
reporting Status
POSTED
time Frame
From C1D1 until death or up to a maximum of 54 months
title
Phase I & Phase II : Toxicity of Treatment Regimen
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice