TriangleNCT01919086 · OUTCOME
Response
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
- Up to eight cycles of treatment, up to 9 months
What was measured
will be tabulated after the completion of cycle four and cycle eight (for those who would have completed 8 cycles), and the overall response rate for the entire population after up to eight cycles will be estimated and compared to the responses reported in the phase II study by Richardson et al. using the 3-drug-combination.
Groups in this outcome
Patients With Multiple Myeloma
This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM. Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22 Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW). Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
| Group | Source count |
|---|---|
| Patients With Multiple Myeloma | 30 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients With Multiple Myeloma | 3 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients With Multiple Myeloma | 25 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients With Multiple Myeloma | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 25
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- will be tabulated after the completion of cycle four and cycle eight (for those who would have completed 8 cycles), and the overall response rate for the entire population after up to eight cycles will be estimated and compared to the responses reported in the phase II study by Richardson et al. using the 3-drug-combination.
- groups
- description
- This is a phase II, single center clinical trial designed to evaluate the response rate and toxicity of a response-adapted, sequential therapy, using bortezomib and dexamethasone, followed by the addition of lenalidomide in non-responders, in patients with untreated MM. Bortezomib: Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m\^2, days 1, 8, 15 and 22 Dexamethasone: Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW). Lenalidomide: Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
- id
- OG000
- title
- Patients With Multiple Myeloma
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to eight cycles of treatment, up to 9 months
- title
- Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice