NCT01146834 · OUTCOME

Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant

Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma · Source last updated 2019-12-27

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 20 days post-transplant

What was measured

Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.

Analysis population: Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis.

Groups in this outcome

Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

Arm B: VELCADE & G-CSF

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

Arm C: CYCLOPHOSPHAMIDE & G-CSF

High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)

Arm D: PLERIXAFOR & G-CSF

G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)

Arm E: PLERIXAFOR, VELCADE, & G-CSF

Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)

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
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF	7
Arm B: VELCADE & G-CSF	4
Arm C: CYCLOPHOSPHAMIDE & G-CSF	11
Arm D: PLERIXAFOR & G-CSF	0
Arm E: PLERIXAFOR, VELCADE, & G-CSF	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF	4	Not reported	Not reported	Not reported	Not reported
Arm B: VELCADE & G-CSF	1	Not reported	Not reported	Not reported	Not reported
Arm C: CYCLOPHOSPHAMIDE & G-CSF	9	Not reported	Not reported	Not reported	Not reported
Arm D: PLERIXAFOR & G-CSF	0	Not reported	Not reported	Not reported	Not reported
Arm E: PLERIXAFOR, VELCADE, & G-CSF	0	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.

ci Lower Limit
-0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.18
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.25
param Type
Risk Difference (RD)
param Value
-0.25
statistical Method
Fisher Exact

Complete source fields

analyses

ci Lower Limit
-0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.18
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.25
param Type
Risk Difference (RD)
param Value
-0.25
statistical Method
Fisher Exact

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
group Id
OG002
value
9
group Id
OG003
value
0
group Id
OG004
value
0

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
4
group Id
OG002
value
11
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants

description

groups

description
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
id
OG000
title
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
description
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
id
OG001
title
Arm B: VELCADE & G-CSF
description
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
id
OG002
title
Arm C: CYCLOPHOSPHAMIDE & G-CSF
description
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
id
OG003
title
Arm D: PLERIXAFOR & G-CSF
description
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
id
OG004
title
Arm E: PLERIXAFOR, VELCADE, & G-CSF

param Type

COUNT_OF_PARTICIPANTS

population Description

Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis.

reporting Status

POSTED

time Frame

20 days post-transplant

title

Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice