TriangleNCT00918333 · OUTCOME
Progression-free Survival (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment
What was measured
Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
Analysis population: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
Groups in this outcome
Phase II (Lymphoma Patients Receiving 20 mg LBL589)
Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Myeloma Patients Receiving 20 mg LBH589)
Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 41 |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | 14 |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 20 |
| Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 3.7 | Not reported | 2.1 | 8.3 | Not reported |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | 2.3 | Not reported | 1.0 | NA | The upper bound of the 95% confidence interval has not yet been reached. |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 4.2 | Not reported | 3.0 | 9.6 | Not reported |
| Phase II (Myeloma Patients Receiving 30/40 mg LBH589) | 4.3 | Not reported | 3.9 | 5.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 8.3
- value
- 3.7
- comment
- The upper bound of the 95% confidence interval has not yet been reached.
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 2.3
- group Id
- OG002
- lower Limit
- 3.0
- upper Limit
- 9.6
- value
- 4.2
- group Id
- OG003
- lower Limit
- 3.9
- upper Limit
- 5.8
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase II (Lymphoma Patients Receiving 20 mg LBL589)
- description
- Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase II (Myeloma Patients Receiving 20 mg LBH589)
- description
- Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
- description
- Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
- param Type
- MEDIAN
- population Description
- Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
- reporting Status
- POSTED
- time Frame
- Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment
- title
- Progression-free Survival (Phase II)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice