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NCT01212952 · OUTCOME

Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2020-04-17

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
2.5 years

What was measured

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).

Analysis population: The first 9 patients accrued(All Phase 1 patients) were evaluated for the MTD.

Groups in this outcome

Phase 1 Dose Level 1

Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone

Phase 1 Dose Level 2

Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone

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 1 Dose Level 13
Phase 1 Dose Level 26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Level 21Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Maximum Tolerated Dose (MTD) (mg/m^2)
    param Value
    1.3
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Maximum Tolerated Dose (MTD) (mg/m^2)
    param Value
    1.3
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    units
    Participants
description
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
groups
  1. description
    Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
    id
    OG000
    title
    Phase 1 Dose Level 1
  2. description
    Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
    id
    OG001
    title
    Phase 1 Dose Level 2
param Type
COUNT_OF_PARTICIPANTS
population Description
The first 9 patients accrued(All Phase 1 patients) were evaluated for the MTD.
reporting Status
POSTED
time Frame
2.5 years
title
Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice