TriangleNCT02780609 · OUTCOME
Complete Response (CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants with CR
- Interval / dispersion
- Not reported
- Time frame
- 3 months post HCT
What was measured
Complete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
Groups in this outcome
Phase 1 Level 1: Selinexor Plus HDM HCT
40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
Phase 1 Level 2: Selinexor Plus HDM HCT
60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Phase 1 Level 3: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Phase 2: Selinexor Plus HDM HCT
80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
| Group | Source count |
|---|---|
| Phase 1 Level 1: Selinexor Plus HDM HCT | 3 |
| Phase 1 Level 2: Selinexor Plus HDM HCT | 3 |
| Phase 1 Level 3: Selinexor Plus HDM HCT | 6 |
| Phase 2: Selinexor Plus HDM HCT | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Level 1: Selinexor Plus HDM HCT | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Level 2: Selinexor Plus HDM HCT | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Level 3: Selinexor Plus HDM HCT | 16.6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Selinexor Plus HDM HCT | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 33.3
- group Id
- OG002
- value
- 16.6
- group Id
- OG003
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- Complete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
- groups
- description
- 40 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
- id
- OG000
- title
- Phase 1 Level 1: Selinexor Plus HDM HCT
- description
- 60 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
- id
- OG001
- title
- Phase 1 Level 2: Selinexor Plus HDM HCT
- description
- 80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
- id
- OG002
- title
- Phase 1 Level 3: Selinexor Plus HDM HCT
- description
- 80 mg Selinexor given orally 2 to 3 hours prior to high dose-melphalan IV infusion Melphalan: Melphalan 100 mg/m\^2 IV over 30-45 minutes. Dexamethasone: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1). Autologous Hematopoietic Cell Transplantation (HCT): Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy. Fosaprepitant: Fosaprepitant at 150 mg IV on days -3 and -2.
- id
- OG003
- title
- Phase 2: Selinexor Plus HDM HCT
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3 months post HCT
- title
- Complete Response (CR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants with CR
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice