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NCT01646762 · OUTCOME

Progression Free Survival at 3 Months

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2017-10-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years

What was measured

The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as: Any one or more of the following: Increase of 25% from lowest value in: * Serum M-component (absolute increase must be ≥ 0.5 g/dl * Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl * Urine M-component (absolute increase must be ≥ 200 mg/24 h) * If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl) * Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (≥11.5 mg/dl) * Decrease in hemoglobin of ≥2 g/dl * Serum creatinine level ≥2 mg/dl

Groups in this outcome

Treatment (Chemotherapy)

Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy)13

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)25.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25.4
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as: Any one or more of the following: Increase of 25% from lowest value in: * Serum M-component (absolute increase must be ≥ 0.5 g/dl * Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl * Urine M-component (absolute increase must be ≥ 200 mg/24 h) * If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl) * Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (≥11.5 mg/dl) * Decrease in hemoglobin of ≥2 g/dl * Serum creatinine level ≥2 mg/dl
groups
  1. description
    Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
    id
    OG000
    title
    Treatment (Chemotherapy)
param Type
NUMBER
reporting Status
POSTED
time Frame
Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years
title
Progression Free Survival at 3 Months
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice