TriangleNCT00474929 · OUTCOME
Proportion of Confirmed Tumor Responses
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 cycles of treatment
What was measured
A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12. Complete Response (CR): * Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio. * Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly. Partial Response (PR): * MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma. * Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline.
Groups in this outcome
Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day
This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II. Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
| Group | Source count |
|---|---|
| Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day | 82 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day | 8.5 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day | 15.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8.5
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 15.9
- title
- Partial Response (PR)
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12. Complete Response (CR): * Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio. * Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly. Partial Response (PR): * MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma. * Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline.
- groups
- description
- This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II. Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
- id
- OG000
- title
- Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 12 cycles of treatment
- title
- Proportion of Confirmed Tumor Responses
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice