NCT03439280 · OUTCOME

Phase 1: Number of Participants With Serious TEAEs

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) · Source last updated 2023-02-24

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

What was measured

TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Groups in this outcome

Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg

Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg

Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg

Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg

Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg

Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.

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 Dose Escalation Cohort: Mezagitamab 45 mg	4
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg	3
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg	12
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg	22
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg	3
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg	1	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg	8	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg	1	Not reported	Not reported	Not reported	Not reported
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
8
group Id
OG004
value
1
group Id
OG005
value
2

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
12
group Id
OG003
value
22
group Id
OG004
value
3
group Id
OG005
value
6
units
Participants

description

groups

description
Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
id
OG000
title
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
description
Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
id
OG001
title
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
description
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
id
OG002
title
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
description
Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
id
OG003
title
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
description
Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
id
OG004
title
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
description
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
id
OG005
title
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set included all enrolled participants who received at least 1 dose of study drug.

reporting Status

POSTED

time Frame

From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

title

Phase 1: Number of Participants With Serious TEAEs

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice