TriangleNCT00722566 · OUTCOME
Number of Patients With Overall Response (Complete Response + Partial Response)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Over 4 cycles (prior to the addition of dexamethasone)
What was measured
Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg
Analysis population: The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.
Groups in this outcome
VELCADE Subcutaneuous
VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
VELCADE Intravenous
VELCADE 1.3 mg/m\^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
| Group | Source count |
|---|---|
| VELCADE Subcutaneuous | 145 |
| VELCADE Intravenous | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| VELCADE Subcutaneuous | 61 | Not reported | Not reported | Not reported | Not reported |
| VELCADE Intravenous | 31 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 6.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 27.1
- group Description
- In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- 0.00201
- param Type
- ORR_SQ - 0.6 ORR_IV
- param Value
- 16.8
- statistical Comment
- CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).
- statistical Method
- Farrrington and Manning
- tested Non Inferiority
- true
Complete source fields
- analyses
- ci Lower Limit
- 6.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 27.1
- group Description
- In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- 0.00201
- param Type
- ORR_SQ - 0.6 ORR_IV
- param Value
- 16.8
- statistical Comment
- CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).
- statistical Method
- Farrrington and Manning
- tested Non Inferiority
- true
- classes
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg
- groups
- description
- VELCADE 1.3 mg/m\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
- id
- OG000
- title
- VELCADE Subcutaneuous
- description
- VELCADE 1.3 mg/m\^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
- id
- OG001
- title
- VELCADE Intravenous
- param Type
- NUMBER
- population Description
- The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.
- reporting Status
- POSTED
- time Frame
- Over 4 cycles (prior to the addition of dexamethasone)
- title
- Number of Patients With Overall Response (Complete Response + Partial Response)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice