TriangleNCT00849251 · OUTCOME
Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m2
- Interval / dispersion
- Not reported
- Time frame
- Up to 90 days after initiation of study treatment
What was measured
If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure.
Analysis population: Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that the MTD for dexamethasone is in a separate table due to the different dosing unit.
Groups in this outcome
Relapsed Disease
Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV or PO pegylated liposomal doxorubicin hydrochloride: Given IV bortezomib: Given IV dexamethasone: Given IV or PO
| Group | Source count |
|---|---|
| Relapsed Disease | 6 |
Reported measurements
MTD cyclophosphamide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relapsed Disease | 300 | Not reported | Not reported | Not reported | Not reported |
MTD bortezomib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relapsed Disease | 1.6 | Not reported | Not reported | Not reported | Not reported |
MTD liposomal doxorubicin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Relapsed Disease | 30 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 300
- title
- MTD cyclophosphamide
- categories
- measurements
- group Id
- OG000
- value
- 1.6
- title
- MTD bortezomib
- categories
- measurements
- group Id
- OG000
- value
- 30
- title
- MTD liposomal doxorubicin
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure.
- groups
- description
- Patients with relapsed multiple myeloma receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV or PO pegylated liposomal doxorubicin hydrochloride: Given IV bortezomib: Given IV dexamethasone: Given IV or PO
- id
- OG000
- title
- Relapsed Disease
- param Type
- NUMBER
- population Description
- Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that the MTD for dexamethasone is in a separate table due to the different dosing unit.
- reporting Status
- POSTED
- time Frame
- Up to 90 days after initiation of study treatment
- title
- Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]
- type
- PRIMARY
- unit Of Measure
- mg/m2
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice