TriangleNCT00918333 · OUTCOME
Duration of Response (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
- The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment
What was measured
Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.
Analysis population: Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
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.
| Group | Source count |
|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 16 |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | 1 |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II (Lymphoma Patients Receiving 20 mg LBL589) | 9.1 | Not reported | 6.5 | 33.5 | Not reported |
| Phase II (Myeloma Patients Receiving 20 mg LBH589) | NA | Not reported | NA | NA | The median and upper bound of the 95% confidence interval have not yet been reached. |
| Phase II (Lymphoma Patients Receiving 30/40 mg LBH589) | 12.9 | Not reported | 4.2 | 30.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 33.5
- value
- 9.1
- comment
- The median and upper bound of the 95% confidence interval have not yet been reached.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 4.2
- upper Limit
- 30.4
- value
- 12.9
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, \< 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) or minor response(MR, defined as ≥25% but \< 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. 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)
- param Type
- MEDIAN
- population Description
- Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- The time from the date at which the patient's objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment
- title
- Duration of Response (Phase II)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice