NCT01217957 · OUTCOME

Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-03-14

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: Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)

What was measured

RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.

Analysis population: All Phase 1 participants.

Groups in this outcome

Phase 1: Ixazomib + Lenalidomide + Dexamethasone

In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until 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

Group	Source count
Phase 1: Ixazomib + Lenalidomide + Dexamethasone	15

Reported measurements

Source class 1

Values in mg/m^2 · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Ixazomib + Lenalidomide + Dexamethasone	2.23	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2.23

denoms

counts
group Id
OG000
value
15
units
Participants

description

RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.

groups

description
In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
id
OG000
title
Phase 1: Ixazomib + Lenalidomide + Dexamethasone

param Type

NUMBER

population Description

All Phase 1 participants.

reporting Status

POSTED

time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)

title

Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone

type

PRIMARY

unit Of Measure

mg/m^2

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

Preserved source evidence · Not medical advice