TriangleNCT02399085 · OUTCOME
Number of Participants With Best Objective Response Rate (ORR)
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
- Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
What was measured
ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
Analysis population: Full analysis set (FAS): The FAS included all participant who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
Groups in this outcome
Treatment (MOR00208, Lenalidomide)
MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
| Group | Source count |
|---|---|
| Treatment (MOR00208, Lenalidomide) | 80 |
Reported measurements
Approximately 4.5 years after first participant enrolled
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | 46 | Not reported | Not reported | Not reported | Not reported |
Approximately 6.5 years after first participant enrolled
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | 46 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 46
- title
- Approximately 4.5 years after first participant enrolled
- categories
- measurements
- group Id
- OG000
- value
- 46
- title
- Approximately 6.5 years after first participant enrolled
- denoms
- counts
- group Id
- OG000
- value
- 80
- units
- Participants
- description
- ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
- groups
- description
- MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.
- id
- OG000
- title
- Treatment (MOR00208, Lenalidomide)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set (FAS): The FAS included all participant who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
- reporting Status
- POSTED
- time Frame
- Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
- title
- Number of Participants With Best Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice