TriangleNCT00580372 · OUTCOME
Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy
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
- 5 years
What was measured
Relapse is defined by the unequivocal objective evidence of recurrent disease such as: myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis \>10% or \>5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for \>2 months.
Groups in this outcome
Study Treatment
Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression. VAD: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 Hemopoietic stem cell procurement: Collection target = 10 x 10\^6 cells/kg EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide
| Group | Source count |
|---|---|
| Study Treatment | 231 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Study Treatment | 28 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- denoms
- counts
- group Id
- OG000
- value
- 231
- units
- Participants
- description
- Relapse is defined by the unequivocal objective evidence of recurrent disease such as: myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis \>10% or \>5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for \>2 months.
- groups
- description
- Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression. VAD: 3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20 High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3: Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1 Hemopoietic stem cell procurement: Collection target = 10 x 10\^6 cells/kg EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide
- id
- OG000
- title
- Study Treatment
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice