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NCT01050790 · OUTCOME

Time to Progression Post Transplant

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma · Source last updated 2018-06-26

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
28 months

What was measured

Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: \>25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); \> 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca \> 11.5 mg/dL or \> 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.

Analysis population: Progression is collected anytime after transplant.

Groups in this outcome

5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant

azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21

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

Analysis denominator · Participants

GroupSource count
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant17

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant14.9Not reported4.228.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        28.1
        value
        14.9
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: \>25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); \> 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca \> 11.5 mg/dL or \> 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.
dispersion Type
Full Range
groups
  1. description
    azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21
    id
    OG000
    title
    5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant
param Type
MEDIAN
population Description
Progression is collected anytime after transplant.
reporting Status
POSTED
time Frame
28 months
title
Time to Progression Post Transplant
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice