NCT01919086 · 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
- 30
- units
- Participants
- 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
- BG000
- title
- Patients With Multiple Myeloma
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 54
- upper Limit
- 84
- value
- 76
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- title
- Female
- measurements
- group Id
- BG000
- value
- 14
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 24
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- 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
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 26
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 2
- 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
- 30
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 30
- units
- Participants
- 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
- BG000
- title
- Patients With Multiple Myeloma
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 54
- upper Limit
- 84
- value
- 76
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- title
- Female
- measurements
- group Id
- BG000
- value
- 14
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 24
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- 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
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 26
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 2
- 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
- 30
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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