NCT04302324 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 9
- units
- Participants
- groups
- description
- Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
- id
- BG000
- title
- Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 4
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 5
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 6
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 4
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- IgG Lambda
- measurements
- group Id
- BG000
- value
- 4
- title
- IgG Kappa
- measurements
- group Id
- BG000
- value
- 1
- title
- IgA Lambda
- measurements
- group Id
- BG000
- value
- 0
- title
- IgA Kappa
- measurements
- group Id
- BG000
- value
- 0
- title
- IgD Kappa
- measurements
- group Id
- BG000
- value
- 1
- title
- Kappa Free light Chain
- measurements
- group Id
- BG000
- value
- 0
- title
- Lambda Free light Chain
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Immunoglobulin Isotype
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 9
- units
- Participants
- groups
- description
- Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
- id
- BG000
- title
- Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 4
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 5
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 6
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 4
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- IgG Lambda
- measurements
- group Id
- BG000
- value
- 4
- title
- IgG Kappa
- measurements
- group Id
- BG000
- value
- 1
- title
- IgA Lambda
- measurements
- group Id
- BG000
- value
- 0
- title
- IgA Kappa
- measurements
- group Id
- BG000
- value
- 0
- title
- IgD Kappa
- measurements
- group Id
- BG000
- value
- 1
- title
- Kappa Free light Chain
- measurements
- group Id
- BG000
- value
- 0
- title
- Lambda Free light Chain
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Immunoglobulin Isotype
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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