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NCT02148913 · OUTCOME

Absence of Dose Limiting Toxicity

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
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.

What was measured

An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any \>/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.

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/m23
Cohort 2b: Carfilzomib 20 mg/m23
Cohort 3: Carfilzomib 27mgm29

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Carfilzomib 15 mg/m23Not reportedNot reportedNot reportedNot reported
Cohort 2: Carfilzomib 20 mg/m21Not reportedNot reportedNot reportedNot reported
Cohort 2b: Carfilzomib 20 mg/m23Not reportedNot reportedNot reportedNot reported
Cohort 3: Carfilzomib 27mgm29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      9
    units
    Participants
description
An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any \>/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.
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
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
title
Absence of Dose Limiting Toxicity
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice