TriangleNCT01054196 · OUTCOME
Duration of Overall Response (DoR)
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
- Until disease progression, death, or for a maximum of 3 years, whichever occurs first
What was measured
The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Analysis population: This outcome measure only assesses Phase 2 participants
Groups in this outcome
Phase 2 Expansion
Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN. In Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1
| Group | Source count |
|---|---|
| Phase 2 Expansion | 28 |
Reported measurements
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 7 | Not reported | Not reported | Not reported | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 6 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 10 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 4 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 1 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Expansion | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- sCR
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- description
- The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
- groups
- description
- Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN. In Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1
- id
- OG000
- title
- Phase 2 Expansion
- param Type
- NUMBER
- population Description
- This outcome measure only assesses Phase 2 participants
- reporting Status
- POSTED
- time Frame
- Until disease progression, death, or for a maximum of 3 years, whichever occurs first
- title
- Duration of Overall Response (DoR)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice