TriangleNCT00718419 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time of response to time of measured progressive disease up to 38.37 months
What was measured
DOR is defined as elapsed time from the first evidence of CR, PR, MR or MinR until date of progression of disease (PD). EBMT RC used for MM. CR: no serum/urine M protein for 6 wk, \<5% PCBM, no LBL size/number increase, no STPC; PR: met some CR criteria plus maintain for 6 wk ≥50% SPEP and PCBM decrease, either decrease of ≥90% or \<200 mg LCE, ≥50% STPC size decrease; MR: met some PR criteria plus maintain for 6 wk decrease of: 25-49% SPEP, 50-89% 24 hour urinary LCE, 25-49% PCBM, 25-49% STPC size. PD: \>25% increase in SPEP, 24 hour urinary LCE, PCBM, STPC size increase, new bone lesion or STPC. IWWM RC used for WM. CR: no serum M protein, malignant cells in BM, or lymphadenopathy/organomegaly; PR: ≥50% IgM and A/O decrease; no new WM symptoms. MinR: ≥25% to \<50% IgM decrease, no A/O progression; no cytopenias or clinical of WM symptoms. PD: \>25% IgM increase, progression of clinical findings or symptoms. For participants who had no PD, DOR was censored at their last contact.
Analysis population: All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR) or minimal response (MR) or minor response (MinR). The numbers of participants censored are 1 (MM) and 13 (WM).
Groups in this outcome
Multiple Myeloma (MM)
Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
Waldenstrom's Macroglobulinemia (WM)
Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
| Group | Source count |
|---|---|
| Multiple Myeloma (MM) | 1 |
| Waldenstrom's Macroglobulinemia (WM) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Multiple Myeloma (MM) | NA | Not reported | NA | NA | Only 1 participant had response, therefore median and 95% Confidence Interval were not calculable. |
| Waldenstrom's Macroglobulinemia (WM) | NA | Not reported | 17.87 | NA | Only 3 participants had events, therefore median was not calculated. The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- Only 1 participant had response, therefore median and 95% Confidence Interval were not calculable.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Only 3 participants had events, therefore median was not calculated. The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG001
- lower Limit
- 17.87
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- DOR is defined as elapsed time from the first evidence of CR, PR, MR or MinR until date of progression of disease (PD). EBMT RC used for MM. CR: no serum/urine M protein for 6 wk, \<5% PCBM, no LBL size/number increase, no STPC; PR: met some CR criteria plus maintain for 6 wk ≥50% SPEP and PCBM decrease, either decrease of ≥90% or \<200 mg LCE, ≥50% STPC size decrease; MR: met some PR criteria plus maintain for 6 wk decrease of: 25-49% SPEP, 50-89% 24 hour urinary LCE, 25-49% PCBM, 25-49% STPC size. PD: \>25% increase in SPEP, 24 hour urinary LCE, PCBM, STPC size increase, new bone lesion or STPC. IWWM RC used for WM. CR: no serum M protein, malignant cells in BM, or lymphadenopathy/organomegaly; PR: ≥50% IgM and A/O decrease; no new WM symptoms. MinR: ≥25% to \<50% IgM decrease, no A/O progression; no cytopenias or clinical of WM symptoms. PD: \>25% IgM increase, progression of clinical findings or symptoms. For participants who had no PD, DOR was censored at their last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
- id
- OG000
- title
- Multiple Myeloma (MM)
- description
- Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
- id
- OG001
- title
- Waldenstrom's Macroglobulinemia (WM)
- param Type
- MEDIAN
- population Description
- All participants who received at least one dose of the study drug and had complete response (CR) or partial response (PR) or minimal response (MR) or minor response (MinR). The numbers of participants censored are 1 (MM) and 13 (WM).
- reporting Status
- POSTED
- time Frame
- Time of response to time of measured progressive disease up to 38.37 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice