NCT01029054 · OUTCOME

The Maximum Tolerated Dose (MTD) of Carfilzomib

Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2017-01-30

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: 6 Months

What was measured

Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.

Analysis population: Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.

Groups in this outcome

Carfilzomib, Lenalidomide w/Dexamethasone

Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.

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
Carfilzomib, Lenalidomide w/Dexamethasone	35

Reported measurements

Source class 1

Values in mg/m^2 · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib, Lenalidomide w/Dexamethasone	36	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
36

denoms

counts
group Id
OG000
value
35
units
Participants

description

Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.

groups

description
Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
id
OG000
title
Carfilzomib, Lenalidomide w/Dexamethasone

param Type

NUMBER

population Description

Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.

reporting Status

POSTED

time Frame

6 Months

title

The Maximum Tolerated Dose (MTD) of Carfilzomib

type

PRIMARY

unit Of Measure

mg/m^2

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

Preserved source evidence · Not medical advice