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NCT03582033 · OUTCOME

Progression Free Survival (PFS): Part A

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma · Source last updated 2024-12-24

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)

What was measured

PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.

Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.

Groups in this outcome

Part A: SEA-BCMA 100mg

Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part A: SEA-BCMA 200mg

Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part A: SEA-BCMA 400mg

Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part A: SEA-BCMA 800mg

Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part A: SEA-BCMA 1600mg

Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

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

Analysis denominator · Participants

GroupSource count
Part A: SEA-BCMA 100mg2
Part A: SEA-BCMA 200mg2
Part A: SEA-BCMA 400mg2
Part A: SEA-BCMA 800mg7
Part A: SEA-BCMA 1600mg22

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg1.7Not reported0.72.8Not reported
Part A: SEA-BCMA 200mg5.9Not reported0.711.0Not reported
Part A: SEA-BCMA 400mg0.7Not reported0.70.7Not reported
Part A: SEA-BCMA 800mg4.4Not reported0.615.5Not reported
Part A: SEA-BCMA 1600mg2.1Not reported0.542.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        2.8
        value
        1.7
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        11.0
        value
        5.9
      3. group Id
        OG002
        lower Limit
        0.7
        upper Limit
        0.7
        value
        0.7
      4. group Id
        OG003
        lower Limit
        0.6
        upper Limit
        15.5
        value
        4.4
      5. group Id
        OG004
        lower Limit
        0.5
        upper Limit
        42.9
        value
        2.1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      22
    units
    Participants
description
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
dispersion Type
Full Range
groups
  1. description
    Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG000
    title
    Part A: SEA-BCMA 100mg
  2. description
    Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG001
    title
    Part A: SEA-BCMA 200mg
  3. description
    Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG002
    title
    Part A: SEA-BCMA 400mg
  4. description
    Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG003
    title
    Part A: SEA-BCMA 800mg
  5. description
    Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG004
    title
    Part A: SEA-BCMA 1600mg
param Type
MEDIAN
population Description
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
reporting Status
POSTED
time Frame
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)
title
Progression Free Survival (PFS): Part A
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice