NCT03246529 · OUTCOME

Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

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: NUMBER
Unit: Percentage of responders
Interval / dispersion: Not reported
Time frame: From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5

What was measured

Percentage of subjects mobilizing ≥2 × 10\^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.

Analysis population: FAS for Part 1 (Part 1 of the study assessed the mobilization using local lab only), ITT for Part 2

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

Group	Source count
BL-8040 + G-CSF Part 1	12
BL-8040 + G-CSF Part 2	80
Placebo + G-CSF Part 2	42

Reported measurements

Central Lab

Analysis denominator · Participants

Group	Source count
BL-8040 + G-CSF Part 1	0
BL-8040 + G-CSF Part 2	80
Placebo + G-CSF Part 2	42

Values in Percentage of responders · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
BL-8040 + G-CSF Part 2	87.5	Not reported	Not reported	Not reported	Not reported
Placebo + G-CSF Part 2	47.6	Not reported	Not reported	Not reported	Not reported

Local Lab

Analysis denominator · Participants

Group	Source count
BL-8040 + G-CSF Part 1	12
BL-8040 + G-CSF Part 2	80
Placebo + G-CSF Part 2	42

Values in Percentage of responders · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
BL-8040 + G-CSF Part 1	100	Not reported	Not reported	Not reported	Not reported
BL-8040 + G-CSF Part 2	96.3	Not reported	Not reported	Not reported	Not reported
Placebo + G-CSF Part 2	64.3	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
<0.0001
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG001
value
87.5
group Id
OG002
value
47.6
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
80
group Id
OG002
value
42
units
Participants
title
Central Lab
categories
measurements
group Id
OG000
value
100
group Id
OG001
value
96.3
group Id
OG002
value
64.3
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
80
group Id
OG002
value
42
units
Participants
title
Local Lab

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
80
group Id
OG002
value
42
units
Participants

description

Percentage of subjects mobilizing ≥2 × 10\^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.

groups

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
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
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

NUMBER

population Description

FAS for Part 1 (Part 1 of the study assessed the mobilization using local lab only), ITT for Part 2

reporting Status

POSTED

time Frame

From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5

title

Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

type

SECONDARY

unit Of Measure

Percentage of responders

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

Preserved source evidence · Not medical advice