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NCT00352001 · OUTCOME

PHASE I: Maximum Tolerated Dose of Lenalidomide

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes · Source last updated 2018-09-19

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

Measure
NUMBER
Unit
mg orally for 21 days
Interval / dispersion
Not reported
Time frame
After 1 courses (1 months)

What was measured

Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.

Analysis population: Participants in Phase I

Groups in this outcome

Lenalidomide and Azacitidine

azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and Azacitidine18

Reported measurements

Source class 1
Values in mg orally for 21 days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Azacitidine10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Participants will be enrolled on the Phase I study portion in blocks of 3 to varying doses of Revlimid® (lenalidomide) and Vidaza® (azacitidine) (Table 1). To determine the MTD, a standard "3+3" design will be used. DLT will be assessed during the first cycle of therapy within each treatment group. No Maximum dose was reach but the go-forward dose agreed upon by the investigators is reported here.
groups
  1. description
    azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. lenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
    id
    OG000
    title
    Lenalidomide and Azacitidine
param Type
NUMBER
population Description
Participants in Phase I
reporting Status
POSTED
time Frame
After 1 courses (1 months)
title
PHASE I: Maximum Tolerated Dose of Lenalidomide
type
PRIMARY
unit Of Measure
mg orally for 21 days

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

Preserved source evidence · Not medical advice