Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00916058 · OUTCOME

Maximum Tolerated Dose (Phase 1)

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma · Source last updated 2019-06-04

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
35 days post-transplant

What was measured

The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\^3 and platelet count of 20,000/mm\^3 untransfused by Day 35 post-transplant.

Analysis population: Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).

Groups in this outcome

Dose Level 1

Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 30 mg/m\^2 given on day 2 of melphalan Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)

Dose Level 2

Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan

Dose Level 3

Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan

Dose Level 4

Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan

Dose Level 5

Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan

Dose Level 6

Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan

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

Analysis denominator · Participants

GroupSource count
Dose Level 13
Dose Level 26
Dose Level 33
Dose Level 43
Dose Level 53
Dose Level 67

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 10Not reportedNot reportedNot reportedNot reported
Dose Level 21Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Dose Level 40Not reportedNot reportedNot reportedNot reported
Dose Level 50Not reportedNot reportedNot reportedNot reported
Dose Level 60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      7
    units
    Participants
description
The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\^3 and platelet count of 20,000/mm\^3 untransfused by Day 35 post-transplant.
groups
  1. description
    Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 30 mg/m\^2 given on day 2 of melphalan Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
    id
    OG000
    title
    Dose Level 1
  2. description
    Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
    id
    OG001
    title
    Dose Level 2
  3. description
    Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
    id
    OG002
    title
    Dose Level 3
  4. description
    Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
    id
    OG003
    title
    Dose Level 4
  5. description
    Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
    id
    OG004
    title
    Dose Level 5
  6. description
    Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min) Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min) Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
    id
    OG005
    title
    Dose Level 6
param Type
COUNT_OF_PARTICIPANTS
population Description
Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).
reporting Status
POSTED
time Frame
35 days post-transplant
title
Maximum Tolerated Dose (Phase 1)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice