Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00560352 · OUTCOME

Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry

Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma · Source last updated 2017-03-13

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
Not reported
Time frame
Day 1 until last tumor assessment (maximum reached: 9 months)

What was measured

S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP\<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein \<200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to \<50% drop in S MP and ≥50% to \<90% drop in U MP and ≥25% to \<50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.

Analysis population: All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone

Groups in this outcome

Dasatinib, 50 mg BID

Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.

Dasatinib, 100 mg QD

Dasatinib, 100 mg, given QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.

Dasatinib, 140 mg QD

Dasatinib, 140 mg, administered QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dasatinib, 50 mg BID7
Dasatinib, 100 mg QD3
Dasatinib, 140 mg QD4

Reported measurements

Complete response (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD0Not reportedNot reportedNot reportedNot reported
Very good partial response (VGPR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD0Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID14.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD0Not reportedNot reportedNot reportedNot reported
Minimal response (MR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD25Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID57.1Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD0Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID14.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD33.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD0Not reportedNot reportedNot reportedNot reported
Unable to determine
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD33.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD25Not reportedNot reportedNot reportedNot reported
Not reported
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib, 50 mg BID14.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 100 mg QD33.3Not reportedNot reportedNot reportedNot reported
Dasatinib, 140 mg QD50Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Very good partial response (VGPR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14.3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Partial response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        25
    title
    Minimal response (MR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        57.1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Stable disease (SD)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14.3
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        0
    title
    Progressive disease (PD)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        25
    title
    Unable to determine
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        14.3
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        50
    title
    Not reported
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    units
    Participants
description
S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP\<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein \<200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to \<50% drop in S MP and ≥50% to \<90% drop in U MP and ≥25% to \<50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.
groups
  1. description
    Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
    id
    OG000
    title
    Dasatinib, 50 mg BID
  2. description
    Dasatinib, 100 mg, given QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
    id
    OG001
    title
    Dasatinib, 100 mg QD
  3. description
    Dasatinib, 140 mg, administered QD with 1.3 mg/m\^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
    id
    OG002
    title
    Dasatinib, 140 mg QD
param Type
NUMBER
population Description
All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
reporting Status
POSTED
time Frame
Day 1 until last tumor assessment (maximum reached: 9 months)
title
Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice