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NCT03582033 · OUTCOME

Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: 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 first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)

What was measured

DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.

Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

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 100mg0
Part A: SEA-BCMA 200mg0
Part A: SEA-BCMA 400mg0
Part A: SEA-BCMA 800mg0
Part A: SEA-BCMA 1600mg3

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 1600mg10.0Not reported5.515.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        5.5
        upper Limit
        15.2
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      3
    units
    Participants
description
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) \&/clinical progression/ investigator. sCR: CR, normal FLC ratio \& absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum\&urine, disappearance of any STP, \&\<5% plasma cells in bone marrow. VGPR: Serum \& UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP \& R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD \& were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
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. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)
title
Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice