TriangleNCT02440464 · OUTCOME
Percentage of Participants With Infections Post-randomization by Infection Type
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 2 years post-randomization
What was measured
All Grade 2 and 3 infections are reported according to the BMT CTN MOP (Manual of Procedures) where a higher grade corresponds to more severe symptoms. The number of participants with post-randomization infections in each treatment arm is described by severity and type of infection.
Analysis population: All randomized participants are included in the analysis.
Groups in this outcome
Ixazomib Maintenance
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
Placebo
Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance. Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
| Group | Source count |
|---|---|
| Ixazomib Maintenance | 21 |
| Placebo | 22 |
Reported measurements
Participants with Infections
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 8 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 11 | Not reported | Not reported | Not reported | Not reported |
Maximum Severity: Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 10 | Not reported | Not reported | Not reported | Not reported |
Maximum Severity: Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 2 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with Bacterial Infection
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 3 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
Participants with Viral Infection
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 11 | Not reported | Not reported | Not reported | Not reported |
Participants with Fungal Infection
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
Participants with Other Infection
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib Maintenance | 1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 11
- title
- Participants with Infections
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 10
- title
- Maximum Severity: Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Maximum Severity: Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Participants with Bacterial Infection
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 11
- title
- Participants with Viral Infection
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Participants with Fungal Infection
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Participants with Other Infection
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- All Grade 2 and 3 infections are reported according to the BMT CTN MOP (Manual of Procedures) where a higher grade corresponds to more severe symptoms. The number of participants with post-randomization infections in each treatment arm is described by severity and type of infection.
- groups
- description
- Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Ixazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
- id
- OG000
- title
- Ixazomib Maintenance
- description
- Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance. Allogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11. Fludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3. Melphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3. Bortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3. Placebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants are included in the analysis.
- reporting Status
- POSTED
- time Frame
- 2 years post-randomization
- title
- Percentage of Participants With Infections Post-randomization by Infection Type
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice