TriangleNCT02195479 · 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
- From first documentation of response up to 2.4 years
What was measured
DOR: participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase\>=0.5 g/dL); Urine M-component (absolute increase\>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%\>=10%); Bone marrow PC's %: absolute%\>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Analysis population: Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. Here 'N'(overall number of participants analyzed) signifies number of participants evaluable for this endpoint.
Groups in this outcome
Velcade, Melphalan and Prednisone (VMP)
Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Participants received Velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
| Group | Source count |
|---|---|
| Velcade, Melphalan and Prednisone (VMP) | 263 |
| Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 318 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade, Melphalan and Prednisone (VMP) | 21.3 | Not reported | 18.4 | NA | Here 'NA' signifies that upper limit of 95% CI was not estimable due to insufficient number of events. |
| Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | NA | Not reported | NA | NA | Here 'NA' signifies that median and 95% CI was not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here 'NA' signifies that upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 18.4
- upper Limit
- NA
- value
- 21.3
- comment
- Here 'NA' signifies that median and 95% CI was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 263
- group Id
- OG001
- value
- 318
- units
- Participants
- description
- DOR: participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase\>=0.5 g/dL); Urine M-component (absolute increase\>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%\>=10%); Bone marrow PC's %: absolute%\>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.
- id
- OG000
- title
- Velcade, Melphalan and Prednisone (VMP)
- description
- Participants received Velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
- id
- OG001
- title
- Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
- param Type
- MEDIAN
- population Description
- Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. Here 'N'(overall number of participants analyzed) signifies number of participants evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- From first documentation of response up to 2.4 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice