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NCT01155583 · OUTCOME

Phase I: Highest Tolerated Low Dose (HTLD)

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
mg/m^2
Interval / dispersion
Not reported
Time frame
During the first 28-day cycle

What was measured

Azacitidine given at low but increasing doses up to 50mg/m2 twice a week. Maximum tolerated dose reported.

Analysis population: Participants in phase 1 portion of study

Groups in this outcome

Arm A - Azacitidine/Lenalidomide/Dexamethasone

Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies

Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone

Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies

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 A - Azacitidine/Lenalidomide/Dexamethasone23
Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone11

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Azacitidine/Lenalidomide/Dexamethasone50Not reportedNot reportedNot reportedNot reported
Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone50Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Azacitidine given at low but increasing doses up to 50mg/m2 twice a week. Maximum tolerated dose reported.
groups
  1. description
    Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
    id
    OG000
    title
    Arm A - Azacitidine/Lenalidomide/Dexamethasone
  2. description
    Patients receive azacitidine subcutaneously once or twice weekly and oral dexamethasone once weekly starting on day 1. Patients also receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses. Patients then continue to receive lenalidomide as maintenance therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC lenalidomide: Given orally dexamethasone: Given orally DNA methylation analysis: Correlative studies gene expression analysis: Correlative studies bone marrow aspiration: Correlative studies immunohistochemistry staining method: Correlative studies reverse transcriptase-polymerase chain reaction: Correlative studies flow cytometry: Correlative studies
    id
    OG001
    title
    Arm B - CKD Azacitidine/Lenalidomide/Dexamethasone
param Type
NUMBER
population Description
Participants in phase 1 portion of study
reporting Status
POSTED
time Frame
During the first 28-day cycle
title
Phase I: Highest Tolerated Low Dose (HTLD)
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice