TriangleNCT02128230 · OUTCOME
The Remission Rate for Participants With High-risk Myeloma
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- from baseline to either death or study completion for each subject (up to approximately 48 months)
What was measured
Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy.
Analysis population: Nineteen (19) subjects discontinued study prior to completion. Only one (1) subject completed all study related activities.
Groups in this outcome
Total Therapy 5B
Induction 1 - MEL-10+CFZ-TD-PACE, Optional Bridging with TD, First Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Inter-Therapy - MEL-20+CFZ-TD-PACE (75%), Optional Bridging with TD, Second Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Consolidation - CFZ-TD-PACE, Maintenance - CFZ-R(T)-D
| Group | Source count |
|---|---|
| Total Therapy 5B | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Therapy 5B | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy.
- groups
- description
- Induction 1 - MEL-10+CFZ-TD-PACE, Optional Bridging with TD, First Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Inter-Therapy - MEL-20+CFZ-TD-PACE (75%), Optional Bridging with TD, Second Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Consolidation - CFZ-TD-PACE, Maintenance - CFZ-R(T)-D
- id
- OG000
- title
- Total Therapy 5B
- param Type
- NUMBER
- population Description
- Nineteen (19) subjects discontinued study prior to completion. Only one (1) subject completed all study related activities.
- reporting Status
- POSTED
- time Frame
- from baseline to either death or study completion for each subject (up to approximately 48 months)
- title
- The Remission Rate for Participants With High-risk Myeloma
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice