NCT01142232 · OUTCOME

Phase I: Number of Patients With Dose Limiting Toxicity

Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma · Source last updated 2019-10-22

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: up to 1 month

What was measured

The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.

Analysis population: All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit (16 patients)

Groups in this outcome

Phase I, Dose Level 1

All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2

Phase I, Dose Level 2

All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2

Phase I, Dose Level 3

All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2

Phase I, Dose Level 4

All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2

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

Analysis denominator · Participants

Group	Source count
Phase I, Dose Level 1	3
Phase I, Dose Level 2	4
Phase I, Dose Level 3	3
Phase I, Dose Level 4	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Phase I, Dose Level 1	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 2	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 3	Not reported	Not reported	Not reported	Not reported
Phase I, Dose Level 4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
6
units
Participants

description

groups

description
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2
id
OG000
title
Phase I, Dose Level 1
description
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2
id
OG001
title
Phase I, Dose Level 2
description
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2
id
OG002
title
Phase I, Dose Level 3
description
All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2
id
OG003
title
Phase I, Dose Level 4

param Type

COUNT_OF_PARTICIPANTS

population Description

All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit (16 patients)

reporting Status

POSTED

time Frame

up to 1 month

title

Phase I: Number of Patients With Dose Limiting Toxicity

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice