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NCT01495598 · OUTCOME

Antitumor Effect of a Second Course of Pomalidomide

Pomalidomide for Kaposi Sarcoma in People With or Without HIV · Source last updated 2022-11-01

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
After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide

What was measured

Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.

Analysis population: 4/28 participants were eligible for a second course of pomalidomide at time of progression within 12 months of treatment cessation.

Groups in this outcome

All Participants - Pomalidomide 5mg Daily

All participants that received a second course of pomalidomide: 5 mg by mouth (p.o.) for 21 of 28 days.

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

Analysis denominator · Participants

GroupSource count
All Participants - Pomalidomide 5mg Daily4

Reported measurements

Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily0Not reportedNot reportedNot reportedNot reported
Clinical Complete Response (CCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily2Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily2Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Clinical Complete Response (CCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable Disease (SD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
groups
  1. description
    All participants that received a second course of pomalidomide: 5 mg by mouth (p.o.) for 21 of 28 days.
    id
    OG000
    title
    All Participants - Pomalidomide 5mg Daily
param Type
COUNT_OF_PARTICIPANTS
population Description
4/28 participants were eligible for a second course of pomalidomide at time of progression within 12 months of treatment cessation.
reporting Status
POSTED
time Frame
After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide
title
Antitumor Effect of a Second Course of Pomalidomide
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice