NCT03439280 · OUTCOME

Percentage of Participants With Minimal Response (MR)

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Up to approximately 3.7 years

What was measured

MR is defined as \>=25% but \<=49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages are rounded off to whole number at the nearest decimal.

Analysis population: Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.

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	19
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 percentage of 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	33	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	11	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	17	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
33
group Id
OG002
value
0
group Id
OG003
value
11
group Id
OG004
value
0
group Id
OG005
value
17

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
12
group Id
OG003
value
19
group Id
OG004
value
3
group Id
OG005
value
6
units
Participants

description

MR is defined as \>=25% but \<=49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages are rounded off to whole number at the nearest decimal.

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

NUMBER

population Description

Response-evaluable analysis set is a subset of the safety analysis set including participants with measurable disease at baseline and at least 1 posttreatment evaluation.

reporting Status

POSTED

time Frame

Up to approximately 3.7 years

title

Percentage of Participants With Minimal Response (MR)

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice