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NCT03582033 · OUTCOME

Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C

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 37 months)

What was measured

BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using 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 C: SEA-BCMA 1600mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part C: SEA-BCMA 800mg and Dexamethasone

Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part C: SEA-BCMA 1600 mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone12
Part C: SEA-BCMA 800mg and Dexamethasone6
Part C: SEA-BCMA 1600 mg and Dexamethasone5

Reported measurements

MRD-negative CR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
sCR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone8Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
CR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
VGPR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
PR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone8Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone20Not reportedNot reportedNot reportedNot reported
MR
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
SD
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone67Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone33Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone60Not reportedNot reportedNot reportedNot reported
DP
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone20Not 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
    title
    MRD-negative CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    sCR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    CR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        0
    title
    VGPR
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        20
    title
    PR
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        0
    title
    MR
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        60
    title
    SD
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        20
    title
    DP
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    units
    Participants
description
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD \& PD per 2016 IMWG. MRD: evaluated using 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 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600mg and Dexamethasone
  2. description
    Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 800mg and Dexamethasone
  3. description
    Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 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 C: SEA-BCMA 1600 mg and Dexamethasone
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 37 months)
title
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice