NCT03246529 · OUTCOME

Graft Durability at 6 Months Post Transplantation

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: 6 Months Post Transplantation

What was measured

Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 6 months post transplantation

Analysis population: Post Transplantation Analysis Set (all randomized subjects treated, with at least 1 apheresis session, and who underwent transplantation). Graft durability was not assessed during Part 1 of the study.

Groups in this outcome

BL-8040 + G-CSF Part 2

Part 2: Randomized, double-blind, placebo-controlled period

Placebo + G-CSF Part 2

Part 2: Randomized, double-blind, placebo-controlled period

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 2	77
Placebo + G-CSF Part 2	37

Reported measurements

Source class 1

Values in Percentage of responders · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
BL-8040 + G-CSF Part 2	80.5	Not reported	Not reported	Not reported	Not reported
Placebo + G-CSF Part 2	83.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
80.5
group Id
OG001
value
83.8

denoms

counts
group Id
OG000
value
77
group Id
OG001
value
37
units
Participants

description

Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 6 months post transplantation

groups

description
Part 2: Randomized, double-blind, placebo-controlled period
id
OG000
title
BL-8040 + G-CSF Part 2
description
Part 2: Randomized, double-blind, placebo-controlled period
id
OG001
title
Placebo + G-CSF Part 2

param Type

NUMBER

population Description

Post Transplantation Analysis Set (all randomized subjects treated, with at least 1 apheresis session, and who underwent transplantation). Graft durability was not assessed during Part 1 of the study.

reporting Status

POSTED

time Frame

6 Months Post Transplantation

title

Graft Durability at 6 Months Post Transplantation

type

SECONDARY

unit Of Measure

Percentage of responders

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

Preserved source evidence · Not medical advice