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NCT03582033 · OUTCOME

AUC0-7 of SEA-BCMA: Part D

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
GEOMETRIC_MEAN
Unit
Day*ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1

What was measured

Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.

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 D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each 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 D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone1

Reported measurements

Source class 1
Values in Day*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone1926.2NANot reportedNot reportedGeometric CV could not be calculated as only 1 participant was available for analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Geometric CV could not be calculated as only 1 participant was available for analysis.
        group Id
        OG000
        spread
        NA
        value
        1926.2
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each 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 D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
param Type
GEOMETRIC_MEAN
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
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
title
AUC0-7 of SEA-BCMA: Part D
type
SECONDARY
unit Of Measure
Day*ug/mL

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

Preserved source evidence · Not medical advice