TriangleNCT01079936 · OUTCOME
Maximum Tolerated Dose (MTD) of Lenalidomide
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/day
- Interval / dispersion
- Not reported
- Time frame
- Assessed at 21-28 Day Cycle
What was measured
There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.
Analysis population: Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.
Groups in this outcome
Lenalidomide + High-Dose Melphalan
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0. Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2 Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion Stem Cell Infusion: Stem cell infusion on Day 0.
| Group | Source count |
|---|---|
| Lenalidomide + High-Dose Melphalan | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide + High-Dose Melphalan | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.
- groups
- description
- Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0. Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2 Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion Stem Cell Infusion: Stem cell infusion on Day 0.
- id
- OG000
- title
- Lenalidomide + High-Dose Melphalan
- param Type
- NUMBER
- population Description
- Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.
- reporting Status
- POSTED
- time Frame
- Assessed at 21-28 Day Cycle
- title
- Maximum Tolerated Dose (MTD) of Lenalidomide
- type
- PRIMARY
- unit Of Measure
- mg/day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice