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NCT02148913 · OUTCOME

Response Rate

Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant in Multiple Myeloma · Source last updated 2024-07-26

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
Disease assessment at day +100, +180, and +365 (+/- 7 days).

What was measured

Find the response rate of the combination of melphalan, bendamustine, and carfilzomib as a conditioning regimen in patients with multiple myeloma undergoing autologous transplantation.

Groups in this outcome

Cohort 1: Carfilzomib 15 mg/m2

Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6

Cohort 2: Carfilzomib 20 mg/m2

Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6

Cohort 2b: Carfilzomib 20 mg/m2

Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5

Cohort 3: Carfilzomib 27mgm2

Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Carfilzomib 15 mg/m23
Cohort 2: Carfilzomib 20 mg/m22
Cohort 2b: Carfilzomib 20 mg/m23
Cohort 3: Carfilzomib 27mgm29

Reported measurements

Source class 1

complete response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Carfilzomib 15 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 2: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 2b: Carfilzomib 20 mg/m20Not reportedNot reportedNot reportedNot reported
Cohort 3: Carfilzomib 27mgm22Not reportedNot reportedNot reportedNot reported

very good partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Carfilzomib 15 mg/m22Not reportedNot reportedNot reportedNot reported
Cohort 2: Carfilzomib 20 mg/m20Not reportedNot reportedNot reportedNot reported
Cohort 2b: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 3: Carfilzomib 27mgm22Not reportedNot reportedNot reportedNot reported

partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Carfilzomib 15 mg/m20Not reportedNot reportedNot reportedNot reported
Cohort 2: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 2b: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 3: Carfilzomib 27mgm22Not reportedNot reportedNot reportedNot reported

progressive disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Carfilzomib 15 mg/m20Not reportedNot reportedNot reportedNot reported
Cohort 2: Carfilzomib 20 mg/m20Not reportedNot reportedNot reportedNot reported
Cohort 2b: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 3: Carfilzomib 27mgm23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      title
      complete response
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      title
      very good partial response
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      title
      partial response
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      title
      progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      9
    units
    Participants
description
Find the response rate of the combination of melphalan, bendamustine, and carfilzomib as a conditioning regimen in patients with multiple myeloma undergoing autologous transplantation.
groups
  1. description
    Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
    id
    OG000
    title
    Cohort 1: Carfilzomib 15 mg/m2
  2. description
    Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
    id
    OG001
    title
    Cohort 2: Carfilzomib 20 mg/m2
  3. description
    Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
    id
    OG002
    title
    Cohort 2b: Carfilzomib 20 mg/m2
  4. description
    Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
    id
    OG003
    title
    Cohort 3: Carfilzomib 27mgm2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Disease assessment at day +100, +180, and +365 (+/- 7 days).
title
Response Rate
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice