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NCT03246529 · OUTCOME

Time to Neutrophil Engraftment, After Auto-HCT

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) · Source last updated 2026-01-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
End of engraftment period, which was defined as 29 days post transplantation

What was measured

Time to neutrophil engraftment after auto-HCT, where engraftment was defined as absolute neutrophil count (ANC) ≥0.5 × 10\^9/L for 3 days or ≥1.0 × 10\^9/L for 1 day following the conditioning regimen associated nadir.

Analysis population: Post Transplantation analysis set (all subjects treated, with at least 1 apheresis session, and who underwent transplantation)

Groups in this outcome

BL-8040 + G-CSF Part 1

Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

BL-8040 + G-CSF Part 2

Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

Placebo + G-CSF Part 2

Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
BL-8040 + G-CSF Part 112
BL-8040 + G-CSF Part 277
Placebo + G-CSF Part 237

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BL-8040 + G-CSF Part 112Not reported1112Not reported
BL-8040 + G-CSF Part 212Not reported1112Not reported
Placebo + G-CSF Part 212Not reported1112Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        12
        value
        12
      2. group Id
        OG001
        lower Limit
        11
        upper Limit
        12
        value
        12
      3. group Id
        OG002
        lower Limit
        11
        upper Limit
        12
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      37
    units
    Participants
description
Time to neutrophil engraftment after auto-HCT, where engraftment was defined as absolute neutrophil count (ANC) ≥0.5 × 10\^9/L for 3 days or ≥1.0 × 10\^9/L for 1 day following the conditioning regimen associated nadir.
dispersion Type
95% Confidence Interval
groups
  1. description
    Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Days 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    OG000
    title
    BL-8040 + G-CSF Part 1
  2. description
    Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    OG001
    title
    BL-8040 + G-CSF Part 2
  3. description
    Part 2: randomized, double-blinded, placebo-controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    OG002
    title
    Placebo + G-CSF Part 2
param Type
MEDIAN
population Description
Post Transplantation analysis set (all subjects treated, with at least 1 apheresis session, and who underwent transplantation)
reporting Status
POSTED
time Frame
End of engraftment period, which was defined as 29 days post transplantation
title
Time to Neutrophil Engraftment, After Auto-HCT
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice