NCT01645930 · FLOW

Participant flow

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

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

groups

description
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
id
FG000
title
Ixazomib+Lenalidomide+Dexamethasone

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
22
type
Participants Ongoing on Study Treatment
reasons
group Id
FG000
num Subjects
12
type
Progressive Disease
reasons
group Id
FG000
num Subjects
4
type
Adverse Event
reasons
group Id
FG000
num Subjects
2
type
Unsatisfactory Therapeutic Response
reasons
group Id
FG000
num Subjects
2
type
Withdrawal by Participant
reasons
group Id
FG000
num Subjects
1
type
Reason not Defined
milestones
achievements
group Id
FG000
num Subjects
43
type
STARTED
achievements
group Id
FG000
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
43
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Asian participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled and received a combination of ixazomib, lenalidomide and dexamethasone.

recruitment Details

Participants took part in the study at 8 investigative sites in Singapore, Hong Kong and South Korea from 17 December 2012 to 11 April 2017. Data cut-off for the analysis was 14 July 2014.

Complete source fields