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NCT03439280 · OUTCOME

Phase 2a: Progression Free Survival (PFS)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to approximately 3.7 years

What was measured

PFS is time from the date of the first dose until the earliest date of disease progression (PD). PD is increase of \>=25% from lowest response value in any of following: Serum M-protein (increase must be \>=0.5 g/dL; serum M component increases \>=1 g/dL are sufficient to define relapse if starting M component is \>=5 g/dL),and/or urine M-protein (increase must be \>=200 mg/24 hour), and/or only in participants without measurable serum and urine M-protein levels, difference between involved/uninvolved FLC levels (increase must be \>10 mg/dL), and only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage (percentage must be \>=10%) or definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or soft tissue plasmacytomas, and development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.

Analysis population: Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Groups in this outcome

Phase 2a: Mezagitamab

Mezagitamab, 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. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2a: Mezagitamab0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
PFS is time from the date of the first dose until the earliest date of disease progression (PD). PD is increase of \>=25% from lowest response value in any of following: Serum M-protein (increase must be \>=0.5 g/dL; serum M component increases \>=1 g/dL are sufficient to define relapse if starting M component is \>=5 g/dL),and/or urine M-protein (increase must be \>=200 mg/24 hour), and/or only in participants without measurable serum and urine M-protein levels, difference between involved/uninvolved FLC levels (increase must be \>10 mg/dL), and only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage (percentage must be \>=10%) or definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or soft tissue plasmacytomas, and development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
groups
  1. description
    Mezagitamab, 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. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.
    id
    OG000
    title
    Phase 2a: Mezagitamab
population Description
Data was not collected as Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan.
reporting Status
POSTED
time Frame
Up to approximately 3.7 years
title
Phase 2a: Progression Free Survival (PFS)
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice