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NCT01079936 · OUTCOME

Number of Participants With Response (CR at Day 90)

Lenalidomide and High-Dose Melphalan · Source last updated 2016-06-06

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 90 after stem cell transplant

What was measured

Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with \<5% plasma cells. There should be \< 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.

Groups in this outcome

25 Mg Lenalidomide

Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

50 mg Lenalidomide

Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

75 mg Lenalidomide

Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

100 mg Lenalidomide

Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.

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

Analysis denominator · Participants

GroupSource count
25 Mg Lenalidomide3
50 mg Lenalidomide5
75 mg Lenalidomide24
100 mg Lenalidomide25

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
25 Mg Lenalidomide0Not reportedNot reportedNot reportedNot reported
50 mg Lenalidomide0Not reportedNot reportedNot reportedNot reported
75 mg Lenalidomide4Not reportedNot reportedNot reportedNot reported
100 mg Lenalidomide4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      24
    4. group Id
      OG003
      value
      25
    units
    Participants
description
Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with \<5% plasma cells. There should be \< 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.
groups
  1. description
    Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    OG000
    title
    25 Mg Lenalidomide
  2. description
    Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    OG001
    title
    50 mg Lenalidomide
  3. description
    Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    OG002
    title
    75 mg Lenalidomide
  4. description
    Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m\^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
    id
    OG003
    title
    100 mg Lenalidomide
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 90 after stem cell transplant
title
Number of Participants With Response (CR at Day 90)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice