NCT02561962 · FLOW

Participant flow

A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-02-01

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

groups

description
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG000
title
Dose Exploration: AMG 224 Dose A
description
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG001
title
Dose Exploration: AMG 224 Dose B
description
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG002
title
Dose Exploration: AMG 224 Dose C
description
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG003
title
Dose Exploration: AMG 224 Dose D
description
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG004
title
Dose Exploration: AMG 224 Dose E
description
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG005
title
Dose Exploration: AMG 224 Dose F
description
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG006
title
Dose Exploration: AMG 224 Dose G
description
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG007
title
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
description
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
id
FG008
title
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
1
group Id
FG005
num Subjects
1
group Id
FG006
num Subjects
2
group Id
FG007
num Subjects
1
group Id
FG008
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
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
1
group Id
FG005
num Subjects
1
group Id
FG006
num Subjects
0
group Id
FG007
num Subjects
3
group Id
FG008
num Subjects
0
type
Decision by sponsor
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
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
group Id
FG008
num Subjects
0
type
Lost to Follow-up
milestones
achievements
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
3
group Id
FG003
num Subjects
3
group Id
FG004
num Subjects
6
group Id
FG005
num Subjects
6
group Id
FG006
num Subjects
5
group Id
FG007
num Subjects
11
group Id
FG008
num Subjects
2
type
STARTED
achievements
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
3
group Id
FG003
num Subjects
3
group Id
FG004
num Subjects
6
group Id
FG005
num Subjects
6
group Id
FG006
num Subjects
5
group Id
FG007
num Subjects
9
group Id
FG008
num Subjects
2
type
Received Treatment
achievements
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
3
group Id
FG003
num Subjects
3
group Id
FG004
num Subjects
4
group Id
FG005
num Subjects
3
group Id
FG006
num Subjects
3
group Id
FG007
num Subjects
7
group Id
FG008
num Subjects
2
type
COMPLETED
achievements
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
2
group Id
FG005
num Subjects
3
group Id
FG006
num Subjects
2
group Id
FG007
num Subjects
4
group Id
FG008
num Subjects
0
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Doses of AMG 224 in dose exploration part range from lowest in Dose A (30mg) up to highest in Dose G (250mg). Specific doses are blinded due to the protection of propriety information.

recruitment Details

A total of 42 participants were enrolled in the study at 4 research centers in Australia and the United States from 20 November 2015 to 21 April 2022. Primary completion date: 30 Nov 2018.

Complete source fields