NCT01832727 · OUTCOME
Best Overall Response in Phase 2 as Assessed by Investigator
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2020-07-13
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
- Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months
What was measured
Disease response and progression were determined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC), except for minimal response (MR) and near complete response (nCR) which was based on the European Group for Blood and Marrow Transplantation (EBMT) criteria. Evaluations reported were assessed by the investigator for participants in Phase 2.
Analysis population: Safety Population
Groups in this outcome
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 300 mg 2/7 Schedule | 18 |
|---|
Reported measurements
Source class 1
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Near Complete Response (nCR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimal Response (MR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable (NE)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Unknown
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 300 mg 2/7 Schedule | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- title
- Stringent Complete Response (sCR)
- title
- Complete Response (CR)
- title
- Near Complete Response (nCR)
- title
- Very Good Partial Response (VGPR)
- title
- Partial Response (PR)
- title
- Minimal Response (MR)
- title
- Stable Disease (SD)
- title
- Progressive Disease (PD)
- title
- Not Evaluable (NE)
- title
- Unknown
- description
- Disease response and progression were determined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC), except for minimal response (MR) and near complete response (nCR) which was based on the European Group for Blood and Marrow Transplantation (EBMT) criteria. Evaluations reported were assessed by the investigator for participants in Phase 2.
- groups
- description
- The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG000
- title
- Phase 2 300 mg 2/7 Schedule
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months
- title
- Best Overall Response in Phase 2 as Assessed by Investigator
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle