TriangleNCT03180736 · OUTCOME
Depth of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- MRD is assessed at the time of suspected CR/sCR and 6, 12, 18, 24, and every 12 months (yearly assessments ±3 months) post CR/sCR in subjects who maintain CR. or sCR, until PD.
What was measured
Depth of response is the analysis of the Minimal Residual Disease (MRD) negativity rate at the sensitivity threshold of 10\^-5 for patients who have achieved CR or better and for patients with suspected CR/sCR.
Analysis population: Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.
Groups in this outcome
Daratumumab+Pomalidomide+Dexamethasone
Daratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Daratumumab: Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Pomalidomide + Dexamethasone
Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 151 |
| Pomalidomide + Dexamethasone | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Daratumumab+Pomalidomide+Dexamethasone | 14.57 | Not reported | 9.36 | 21.22 | Not reported |
| Pomalidomide + Dexamethasone | 1.96 | Not reported | 0.41 | 5.62 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.36
- upper Limit
- 21.22
- value
- 14.57
- group Id
- OG001
- lower Limit
- 0.41
- upper Limit
- 5.62
- value
- 1.96
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- Depth of response is the analysis of the Minimal Residual Disease (MRD) negativity rate at the sensitivity threshold of 10\^-5 for patients who have achieved CR or better and for patients with suspected CR/sCR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Daratumumab at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Daratumumab: Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Daratumumab+Pomalidomide+Dexamethasone
- description
- Pomalidomide 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle Dexamethasone 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG001
- title
- Pomalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.
- reporting Status
- POSTED
- time Frame
- MRD is assessed at the time of suspected CR/sCR and 6, 12, 18, 24, and every 12 months (yearly assessments ±3 months) post CR/sCR in subjects who maintain CR. or sCR, until PD.
- title
- Depth of Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice