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NCT03582033 · OUTCOME

Overall Survival (OS): 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 date of start of study treatment until date of death or censoring date (maximum up to 45 months)

What was measured

OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 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 100mg9.2Not reported3.09.2Not reported
Part A: SEA-BCMA 200mg37.5Not reported11.137.5Not reported
Part A: SEA-BCMA 400mg8.1Not reported0.915.3Not reported
Part A: SEA-BCMA 800mg19.2Not reported1.345.3Not reported
Part A: SEA-BCMA 1600mg19.7Not reported0.944.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        9.2
        value
        9.2
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        37.5
        value
        37.5
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        15.3
        value
        8.1
      4. group Id
        OG003
        lower Limit
        1.3
        upper Limit
        45.3
        value
        19.2
      5. group Id
        OG004
        lower Limit
        0.9
        upper Limit
        44.3
        value
        19.7
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
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 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 date of start of study treatment until date of death or censoring date (maximum up to 45 months)
title
Overall Survival (OS): Part A
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice