NCT03439280 · OUTCOME

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

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: Cycle 1 (cycle length=28 days)

What was measured

DLTs were defined as any of the following events: Grade 4 laboratory abnormalities, except those events that were clearly due to extraneous causes; nonhematologic TEAEs of grade greater than or equal to (\>=3) except grade 3 nausea/vomiting, fatigue lasting less than 72 hours, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that resolves to grade less than or equal to (\<=)1 or baseline within 7 days, injection reaction (IR) that responds to symptomatic treatment; Hematologic TEAEs of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade \>=4, except grade \>=3 hemolysis, grade 3 low platelet or higher count with clinically meaningful bleeding; and an incomplete recovery from treatment-related toxicity causing a greater than (\>) 2-week delay in the next scheduled injection before the initiation of Cycle 2 will be considered a DLT.

Analysis population: DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.

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	10
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg	17
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg	3
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex	4

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	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex	1	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
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
10
group Id
OG003
value
17
group Id
OG004
value
3
group Id
OG005
value
4
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

DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.

reporting Status

POSTED

time Frame

Cycle 1 (cycle length=28 days)

title

Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice