Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03582033 · OUTCOME

Percentage of Participants With Best Overall Response (BOR) 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)

What was measured

BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. 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: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.

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

Minimal Residual Disease (MRD)-negative complete response (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg0Not reportedNot reportedNot reportedNot reported
Stringent complete response (sCR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg0Not reportedNot reportedNot reportedNot reported
Complete response (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg0Not reportedNot reportedNot reportedNot reported
Very good partial response (VGPR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg5Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg9Not reportedNot reportedNot reportedNot reported
Minimal response (MR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg5Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg50Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg100Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg86Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg45Not reportedNot reportedNot reportedNot reported
Progressive disease (DP)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: SEA-BCMA 100mg50Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 200mg0Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 400mg100Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 800mg14Not reportedNot reportedNot reportedNot reported
Part A: SEA-BCMA 1600mg36Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
        0
    title
    Minimal Residual Disease (MRD)-negative complete response (CR)
  2. categories
    1. measurements
      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
        0
    title
    Stringent complete response (sCR)
  3. categories
    1. measurements
      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
        0
    title
    Complete response (CR)
  4. categories
    1. measurements
      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
        5
    title
    Very good partial response (VGPR)
  5. categories
    1. measurements
      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
        9
    title
    Partial response (PR)
  6. categories
    1. measurements
      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
        5
    title
    Minimal response (MR)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        86
      5. group Id
        OG004
        value
        45
    title
    Stable disease (SD)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        100
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        36
    title
    Progressive disease (DP)
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
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD \& PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay \& carried out on relevant specimen to understand activity of SEA-BCMA. 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: SMP \& UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP \& R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP \& UMP are unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP \& R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) \&/clinical progression/investigator.
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
NUMBER
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 first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
title
Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice