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NCT00790842 · OUTCOME

Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction · Source last updated 2018-10-24

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
First cycle of therapy (28 days)

What was measured

Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause

Analysis population: Patients treated during the dose finding phase of the study

Groups in this outcome

Group A Lenalidomide 10 mg/Day

CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.

Group A Lenalidomide 15 mg/Day

CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group A Lenalidomide 25 mg/Day

CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group B Lenalidomide 15 mg/2 Days

CrCl\<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group B Lenalidomide 25 mg/2 Days

CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group B Lenalidomide 15 mg/Day

CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group B Lenalidomide 25 mg/Day

CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group C Lenalidomide 15 mg 3x/Week

CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group C Lenalidomide 10 mg/Day

CrCl \< 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group C Lenalidomide 15 mg/Day

CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

Group C Lenalidomide 25 mg/Day

CrCl \< 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.

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

Analysis denominator · Participants

GroupSource count
Group A Lenalidomide 10 mg/Day6
Group A Lenalidomide 15 mg/Day3
Group A Lenalidomide 25 mg/Day6
Group B Lenalidomide 15 mg/2 Days3
Group B Lenalidomide 25 mg/2 Days3
Group B Lenalidomide 15 mg/Day3
Group B Lenalidomide 25 mg/Day8
Group C Lenalidomide 15 mg 3x/Week3
Group C Lenalidomide 10 mg/Day3
Group C Lenalidomide 15 mg/Day3
Group C Lenalidomide 25 mg/Day5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A Lenalidomide 10 mg/Day0Not reportedNot reportedNot reportedNot reported
Group A Lenalidomide 15 mg/Day0Not reportedNot reportedNot reportedNot reported
Group A Lenalidomide 25 mg/Day0Not reportedNot reportedNot reportedNot reported
Group B Lenalidomide 15 mg/2 Days0Not reportedNot reportedNot reportedNot reported
Group B Lenalidomide 25 mg/2 Days0Not reportedNot reportedNot reportedNot reported
Group B Lenalidomide 15 mg/Day0Not reportedNot reportedNot reportedNot reported
Group B Lenalidomide 25 mg/Day0Not reportedNot reportedNot reportedNot reported
Group C Lenalidomide 15 mg 3x/Week0Not reportedNot reportedNot reportedNot reported
Group C Lenalidomide 10 mg/Day0Not reportedNot reportedNot reportedNot reported
Group C Lenalidomide 15 mg/Day0Not reportedNot reportedNot reportedNot reported
Group C Lenalidomide 25 mg/Day0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day
    group Description
    Recommended Phase 2 dose for Group A
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Comment
    Recommended Phase 2 dose for Group A
    non Inferiority Type
    OTHER
    param Type
    Dose in milligrams per day
    param Value
    25
  2. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis
    group Description
    Recommended phase 2 dose for patients in Group B
    group Ids
    1. OG003
    2. OG004
    3. OG005
    4. OG006
    non Inferiority Comment
    Recommended phase 2 dose for patients in Group B
    non Inferiority Type
    OTHER
    param Type
    Dose in milligrams/day
    param Value
    25
  3. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis
    group Description
    Recommended phase 2 dose for Group C
    group Ids
    1. OG007
    2. OG008
    3. OG009
    4. OG010
    non Inferiority Comment
    Recommended phase 2 dose for Group C
    non Inferiority Type
    OTHER
    param Type
    Lenalidomide dose in mg/day
    param Value
    25
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day
    group Description
    Recommended Phase 2 dose for Group A
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Comment
    Recommended Phase 2 dose for Group A
    non Inferiority Type
    OTHER
    param Type
    Dose in milligrams per day
    param Value
    25
  2. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis
    group Description
    Recommended phase 2 dose for patients in Group B
    group Ids
    1. OG003
    2. OG004
    3. OG005
    4. OG006
    non Inferiority Comment
    Recommended phase 2 dose for patients in Group B
    non Inferiority Type
    OTHER
    param Type
    Dose in milligrams/day
    param Value
    25
  3. ci Num Sides
    TWO_SIDED
    estimate Comment
    Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis
    group Description
    Recommended phase 2 dose for Group C
    group Ids
    1. OG007
    2. OG008
    3. OG009
    4. OG010
    non Inferiority Comment
    Recommended phase 2 dose for Group C
    non Inferiority Type
    OTHER
    param Type
    Lenalidomide dose in mg/day
    param Value
    25
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      5
    units
    Participants
description
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
groups
  1. description
    CrCl 30-60 mL/min, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days along with anticoagulants.
    id
    OG000
    title
    Group A Lenalidomide 10 mg/Day
  2. description
    CrCl 30-60 mL/min, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG001
    title
    Group A Lenalidomide 15 mg/Day
  3. description
    CrCL 30-60 mL/min, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG002
    title
    Group A Lenalidomide 25 mg/Day
  4. description
    CrCl\<30 mL/min, not on dialysis, Lenalidomide at 15 mg/every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG003
    title
    Group B Lenalidomide 15 mg/2 Days
  5. description
    CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg every 2 days for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG004
    title
    Group B Lenalidomide 25 mg/2 Days
  6. description
    CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG005
    title
    Group B Lenalidomide 15 mg/Day
  7. description
    CrCl \< 30 mL/min, not on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG006
    title
    Group B Lenalidomide 25 mg/Day
  8. description
    CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg 3 times per week for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG007
    title
    Group C Lenalidomide 15 mg 3x/Week
  9. description
    CrCl \< 30 mL/min, on dialysis, Lenalidomide at 10 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG008
    title
    Group C Lenalidomide 10 mg/Day
  10. description
    CrCl \< 30 mL/min, on dialysis, Lenalidomide at 15 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG009
    title
    Group C Lenalidomide 15 mg/Day
  11. description
    CrCl \< 30 ml/min, on dialysis, Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days, along with anticoagulants.
    id
    OG010
    title
    Group C Lenalidomide 25 mg/Day
param Type
COUNT_OF_PARTICIPANTS
population Description
Patients treated during the dose finding phase of the study
reporting Status
POSTED
time Frame
First cycle of therapy (28 days)
title
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice