TriangleNCT02441686 · OUTCOME
Median Time to Progression (TTP)
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
- Disease was assessed up to 41.2 months.
What was measured
Median TTP based on KM method is defined as the time from first dose of treatment to the first progression event or censored at date last disease assessment. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
Groups in this outcome
Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
| Group | Source count |
|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide, Subcutaneous Bortezomib, Dexamethasone | NA | Not reported | 29.7 | NA | Limited number of participants progressed during the observation period. |
Complete source fields
- classes
- categories
- measurements
- comment
- Limited number of participants progressed during the observation period.
- group Id
- OG000
- lower Limit
- 29.7
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- Median TTP based on KM method is defined as the time from first dose of treatment to the first progression event or censored at date last disease assessment. PD, based on IMWG criteria, requires 1+ of the following: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \>25% increase in 24h urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lenalidomide (R): 25 mg on days 1-14 orally Subcutaneous Bortezomib (sqV): 1.3 mg/m\^2 on days 1, 4, 8 and 11 Dexamethasone (d): 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 Stem cell mobilization occurs at the end of Cycle 4. Participants may elect to stop treatment at the end of Induction Cycle 4 and proceed to autologous stem cell transplant (ASCT) with melphalan 200 mg/m\^2 conditioning, or receive a full 8 cycles of RsqVd induction therapy. RsqVd cycle duration is 21-days. Maintenance follows with the specific regimen determined by risk category. High-risk participants defined as those with International Staging System (ISS) stage II or stage III disease and/or high-risk cytogenetics including t(4;14), t(4; 16), del(17p) receive sqV of 1.3 mg/m\^2 on days 1 and 15 in addition to R 10mg (15mg after cycle 3 if tolerated) on days 1-21 of 28-day cycle. Standard-risk participants receive R monotherapy.
- id
- OG000
- title
- Lenalidomide, Subcutaneous Bortezomib, Dexamethasone
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Disease was assessed up to 41.2 months.
- title
- Median Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice