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NCT01355705 · OUTCOME

Progression-free Survival (PFS)

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2018-09-18

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
9 months

What was measured

Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of: * Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline, * Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline * New or increased bone lesions or plasmacytomas * Serum calcium \> 11.5 mg/dL (attributed to increased plasma cells)

Groups in this outcome

Amrubicin + Lenalidomide + Dexamethasone

Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2

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

Analysis denominator · Participants

GroupSource count
Amrubicin + Lenalidomide + Dexamethasone13

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Amrubicin + Lenalidomide + Dexamethasone96Not reported21232Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21
        upper Limit
        232
        value
        96
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of: * Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline, * Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline * New or increased bone lesions or plasmacytomas * Serum calcium \> 11.5 mg/dL (attributed to increased plasma cells)
dispersion Type
Full Range
groups
  1. description
    Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2
    id
    OG000
    title
    Amrubicin + Lenalidomide + Dexamethasone
param Type
MEDIAN
reporting Status
POSTED
time Frame
9 months
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice