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NCT01155583 · OUTCOME

Percent of Participants With Clinical Benefit and Response According to International Response Criteria

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2020-11-16

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
at 12 months

What was measured

Percent of participants with response according to international response criteria (\>= PR) and percent of participants with clinical benefit response (\>= minor response according to adapted EBMT criteria). Determined with serum and 24 hour urine protein electrophoresis, and as appropriate, supplemented by immunofixation, serum free light chain assay, and bone marrow examination. Response before high dose melphalan and autologous stem cell transplant will also be confirmed by two separate blood and 24 hour urine tests between the last dose of combination therapy and the first dose of the mobilizing agent.

Analysis population: Response-evaluable participants

Groups in this outcome

Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)

Participants receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Participants also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Participants then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Participants Who Received HTLD/HTLD-CKD

Participants who received HTLD and HTLD-CKD dose: Azacitidine 50mg/m2 2x week + Lenalidomide 25mg (or 10mg for CKD) d1-21 every 28d + Dexamethasone 40mg once a week

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

Analysis denominator · Participants

GroupSource count
Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)41
Participants Who Received HTLD/HTLD-CKD22

Reported measurements

International response criteria (>= PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)22Not reportedNot reportedNot reportedNot reported
Participants Who Received HTLD/HTLD-CKD23Not reportedNot reportedNot reportedNot reported
clinical benefit response (>= minor response)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)32Not reportedNot reportedNot reportedNot reported
Participants Who Received HTLD/HTLD-CKD32Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        23
    title
    International response criteria (>= PR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        32
    title
    clinical benefit response (>= minor response)
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      22
    units
    Participants
description
Percent of participants with response according to international response criteria (\>= PR) and percent of participants with clinical benefit response (\>= minor response according to adapted EBMT criteria). Determined with serum and 24 hour urine protein electrophoresis, and as appropriate, supplemented by immunofixation, serum free light chain assay, and bone marrow examination. Response before high dose melphalan and autologous stem cell transplant will also be confirmed by two separate blood and 24 hour urine tests between the last dose of combination therapy and the first dose of the mobilizing agent.
groups
  1. description
    Participants receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Participants also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Participants then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Overall Study - (Azacitidine/Lenalidomide/Dexamethasone)
  2. description
    Participants who received HTLD and HTLD-CKD dose: Azacitidine 50mg/m2 2x week + Lenalidomide 25mg (or 10mg for CKD) d1-21 every 28d + Dexamethasone 40mg once a week
    id
    OG001
    title
    Participants Who Received HTLD/HTLD-CKD
param Type
NUMBER
population Description
Response-evaluable participants
reporting Status
POSTED
time Frame
at 12 months
title
Percent of Participants With Clinical Benefit and Response According to International Response Criteria
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice