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NCT00843882 · OUTCOME

Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia · Source last updated 2026-09-02

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed after completion of 16 weeks of treatment

What was measured

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.

Analysis population: Evaluable patients who fail to experience a MER with lenalidomide monotherapy and receive salvage combination therapy (crossover from arm A to arm B)

Groups in this outcome

Arm B (Lenalidomide + Epoetin Alfa; Crossover)

Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.

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

Analysis denominator · Participants

GroupSource count
Arm B (Lenalidomide + Epoetin Alfa; Crossover)44

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (Lenalidomide + Epoetin Alfa; Crossover)0.25Not reported0.130.40Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.13
        upper Limit
        0.40
        value
        0.25
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
    id
    OG000
    title
    Arm B (Lenalidomide + Epoetin Alfa; Crossover)
param Type
NUMBER
population Description
Evaluable patients who fail to experience a MER with lenalidomide monotherapy and receive salvage combination therapy (crossover from arm A to arm B)
reporting Status
POSTED
time Frame
Assessed after completion of 16 weeks of treatment
title
Proportion of Patients With Major Erythroid Response (MER) to Salvage Combination Therapy
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice