NCT01349569 · OUTCOME
Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells
Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission · Source last updated 2019-01-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of cells
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Cycle 3 Day 14, end of study (up to 1 year)
What was measured
Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.
Analysis population: Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. Only 8/15 participants experienced complete response (CR), therefore only 8 participants analyzed in the CR rows and 7 participants analyzed in the progressive disease (PD) rows.
Groups in this outcome
Pre-vaccine (Baseline)
Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
GVAX Vaccine
Allogeneic Myeloma Vaccine: A total of 4 doses will be administered. The first three at monthly intervals and a booster at 6 months from the initial dose. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
Prevnar Vaccine
Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
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 |
|---|
| Pre-vaccine (Baseline) | 15 |
|---|
| GVAX Vaccine | 15 |
|---|
| Prevnar Vaccine | 15 |
|---|
Reported measurements
Complete Response (CR) patients at Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 8 |
|---|
| GVAX Vaccine | 8 |
|---|
| Prevnar Vaccine | 8 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 1.2 | 0.4 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 0.36 | 0.6 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 0 | NA | Not reported | Not reported | Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation |
|---|
CR patients at Cycle 3 Day 14
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 8 |
|---|
| GVAX Vaccine | 8 |
|---|
| Prevnar Vaccine | 8 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 7.3 | 2.6 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 13.3 | 3 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 4.54 | 2.1 | Not reported | Not reported | Not reported |
|---|
CR patients at end of Study
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 8 |
|---|
| GVAX Vaccine | 8 |
|---|
| Prevnar Vaccine | 8 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 6.3 | 1.4 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 13.7 | 5.1 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 3.6 | 1.4 | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD) patients at Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 7 |
|---|
| GVAX Vaccine | 7 |
|---|
| Prevnar Vaccine | 7 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 0.43 | 0.44 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 0.45 | 0.7 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 0 | NA | Not reported | Not reported | Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation |
|---|
PD patients at Cycle 3 Day 14
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 7 |
|---|
| GVAX Vaccine | 7 |
|---|
| Prevnar Vaccine | 7 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 1.7 | 2.9 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 5.7 | 1.4 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 0 | NA | Not reported | Not reported | Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation |
|---|
PD patients at end of study
Analysis denominator · Participants
| Group | Source count |
|---|
| Pre-vaccine (Baseline) | 7 |
|---|
| GVAX Vaccine | 7 |
|---|
| Prevnar Vaccine | 7 |
|---|
Values in percentage of cells · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pre-vaccine (Baseline) | 0.4 | 0 | Not reported | Not reported | Not reported |
|---|
| GVAX Vaccine | 0.21 | 0 | Not reported | Not reported | Not reported |
|---|
| Prevnar Vaccine | 1.7 | 0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.4
- value
- 1.2
- group Id
- OG001
- spread
- 0.6
- value
- 0.36
- comment
- Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation
- group Id
- OG002
- spread
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Complete Response (CR) patients at Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 2.6
- value
- 7.3
- group Id
- OG001
- spread
- 3
- value
- 13.3
- group Id
- OG002
- spread
- 2.1
- value
- 4.54
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- CR patients at Cycle 3 Day 14
- categories
- measurements
- group Id
- OG000
- spread
- 1.4
- value
- 6.3
- group Id
- OG001
- spread
- 5.1
- value
- 13.7
- group Id
- OG002
- spread
- 1.4
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- CR patients at end of Study
- categories
- measurements
- group Id
- OG000
- spread
- 0.44
- value
- 0.43
- group Id
- OG001
- spread
- 0.7
- value
- 0.45
- comment
- Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation
- group Id
- OG002
- spread
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Progressive Disease (PD) patients at Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 2.9
- value
- 1.7
- group Id
- OG001
- spread
- 1.4
- value
- 5.7
- comment
- Mean percentage of CD3+/CSFSE-low/IFN-gamma+ cells was zero, therefore no standard of deviation
- group Id
- OG002
- spread
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- PD patients at Cycle 3 Day 14
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 0.4
- group Id
- OG001
- spread
- 0
- value
- 0.21
- group Id
- OG002
- spread
- 0
- value
- 1.7
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- PD patients at end of study
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 15
- units
- Participants
- description
- Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.
- dispersion Type
- Standard Deviation
- groups
- description
- Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
- id
- OG000
- title
- Pre-vaccine (Baseline)
- description
- Allogeneic Myeloma Vaccine: A total of 4 doses will be administered. The first three at monthly intervals and a booster at 6 months from the initial dose. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
- id
- OG001
- title
- GVAX Vaccine
- description
- Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
- id
- OG002
- title
- Prevnar Vaccine
- param Type
- MEAN
- population Description
- Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. Only 8/15 participants experienced complete response (CR), therefore only 8 participants analyzed in the CR rows and 7 participants analyzed in the progressive disease (PD) rows.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 3 Day 14, end of study (up to 1 year)
- title
- Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells
- type
- SECONDARY
- unit Of Measure
- percentage of cells
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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