NCT01335685 · FLOW

Participant flow

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

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

groups

description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).
id
FG000
title
Arm A: Ixazomib 3.0 mg
description
Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).
id
FG001
title
Arm A: Ixazomib 3.7 mg
description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).
id
FG002
title
Arm B: Ixazomib 3.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
id
FG003
title
Arm B: Ixazomib 4.0 mg
description
Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).
id
FG004
title
Arm B: Ixazomib 5.5 mg
description
Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).
id
FG005
title
Arm C: Ixazomib 3.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).
id
FG006
title
Arm C: Ixazomib 4.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).
id
FG007
title
Arm D: Ixazomib 4.0 mg

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
10
group Id
FG004
num Subjects
0
group Id
FG005
num Subjects
4
group Id
FG006
num Subjects
2
group Id
FG007
num Subjects
3
type
Study Terminated by Sponsor
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
1
group Id
FG004
num Subjects
0
group Id
FG005
num Subjects
0
group Id
FG006
num Subjects
0
group Id
FG007
num Subjects
0
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
0
group Id
FG005
num Subjects
1
group Id
FG006
num Subjects
0
group Id
FG007
num Subjects
0
type
Reason not Specified
milestones
achievements
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
4
group Id
FG002
num Subjects
3
group Id
FG003
num Subjects
26
group Id
FG004
num Subjects
5
group Id
FG005
num Subjects
6
group Id
FG006
num Subjects
4
group Id
FG007
num Subjects
6
type
STARTED
achievements
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
15
group Id
FG004
num Subjects
5
group Id
FG005
num Subjects
1
group Id
FG006
num Subjects
2
group Id
FG007
num Subjects
3
type
COMPLETED
achievements
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
2
group Id
FG003
num Subjects
11
group Id
FG004
num Subjects
0
group Id
FG005
num Subjects
5
group Id
FG006
num Subjects
2
group Id
FG007
num Subjects
3
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Participants with a diagnosis of multiple myeloma (previously untreated) were enrolled to receive ixazomib orally at various doses in Phase 1. Only Arm B: Ixazomib 4.0 mg continued in Phase 2.

recruitment Details

Participants took part in the study at 14 investigative sites in United States Canada, United Kingdom, Spain, and Czech Republic from 27 June 2011 to 29 December 2016.

Complete source fields