Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type
Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy · Source last updated 2016-02-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From the date of randomization up to Week 104
What was measured
Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.
Analysis population: Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. "n" signifies number of participants evaluable for the particular HLA type, respectively.
Groups in this outcome
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
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
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
17
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
15
Reported measurements
HLA A01 (n=3, 7)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA A01 not present (n=14, 8)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA A02 present (n=10, 10)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA A02 not present (n=7, 5)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA A03 present (n=4, 3)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA A03 not present (n=13, 12)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA A24 present (n=7, 1)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
HLA A24 not present (n=10, 14)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
HLA A68 present (n=2, 3)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA A68 not present (n=15, 12)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
8
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA B07 present (n=6, 5)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA B07 not present (n=11, 10)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA B08 present (n=3, 6)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA B08 not present (n=14, 9)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA B15 present (n=4, 1)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA B15 not present (n=13, 14)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA B27 present (n=3, 2)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
HLA B27 not present (n=14, 13)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
HLA B35 present (n=2, 4)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA B35 not present (n=15, 11)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA B44 present (n=4, 2)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA B44 not present (n=13, 13)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA C01 present (n=1, 4)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA C01 not present (n=16, 11)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA C02 present (n=3, 1)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA C02 not present (n=14, 14)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA C03 present (n=9, 2)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA C03 not present (n=8, 13)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA C04 present (n=1, 3)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA C04 not present (n=16, 12)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA C07 present (n=12, 10)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA C07 not present (n=5, 5)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DQB02 present (n=2, 6)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DQB02 not present (n=15, 9)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
8
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA DQB03 present (n=11, 9)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
HLA DQB03 not present (n=6, 6)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA DQB05 present (n=6, 2)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA DQB05 not present (n=11, 13)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA DQB06 present (n=7, 5)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DQB06 not present (n=10, 10)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA DRB01 present (n=3, 1)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
HLA DRB01 not present (n=14, 14)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
HLA DRB03 present (n=2, 6)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DRB03 not present (n=15, 9)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
8
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA DRB04 present (n=11, 6)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DRB04 not present (n=6, 9)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA DRB11 present (n=2, 5)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
HLA DRB11 not present (n=15, 10)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
7
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
4
Not reported
Not reported
Not reported
Not reported
HLA DRB13 present (n=5, 2)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
1
Not reported
Not reported
Not reported
Not reported
HLA DRB13 not present (n=12, 13)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
6
Not reported
Not reported
Not reported
Not reported
HLA DRB15 present (n=5, 3)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
3
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
2
Not reported
Not reported
Not reported
Not reported
HLA DRB15 not present (n=12, 12)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
5
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
title
HLA A01 (n=3, 7)
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
title
HLA A01 not present (n=14, 8)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
title
HLA A02 present (n=10, 10)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
title
HLA A02 not present (n=7, 5)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
HLA A03 present (n=4, 3)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
title
HLA A03 not present (n=13, 12)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
HLA A24 present (n=7, 1)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
6
title
HLA A24 not present (n=10, 14)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
HLA A68 present (n=2, 3)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
5
title
HLA A68 not present (n=15, 12)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
title
HLA B07 present (n=6, 5)
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
5
title
HLA B07 not present (n=11, 10)
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
15
units
Participants
description
Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.
groups
description
Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
id
OG000
title
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
description
Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.
Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
id
OG001
title
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
param Type
NUMBER
population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. "n" signifies number of participants evaluable for the particular HLA type, respectively.
reporting Status
POSTED
time Frame
From the date of randomization up to Week 104
title
Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type
Triangle