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NCT01054144 · OUTCOME

Combined Therapy - Median Progression Free Survival

Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2021-10-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 36 months

What was measured

Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)

Analysis population: Number of participants who received response adaptive therapy

Groups in this outcome

Response Adapted Therapy

Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue

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

Analysis denominator · Participants

GroupSource count
Response Adapted Therapy9

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Response Adapted Therapy36Not reported29.7NANot reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached
        group Id
        OG000
        lower Limit
        29.7
        upper Limit
        NA
        value
        36
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue
    id
    OG000
    title
    Response Adapted Therapy
param Type
MEDIAN
population Description
Number of participants who received response adaptive therapy
reporting Status
POSTED
time Frame
up to 36 months
title
Combined Therapy - Median Progression Free Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice