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NCT00972959 · OUTCOME

Bone Mineral Density (BMD)

Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy · Source last updated 2014-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
T-score
Interval / dispersion
Full Range
Time frame
day 168

What was measured

BMD of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)

Analysis population: Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)

Groups in this outcome

Bortezomib/Dexamethasone/Zoledronic Acid

For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles

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

Analysis denominator · Participants

GroupSource count
Bortezomib/Dexamethasone/Zoledronic Acid15

Reported measurements

Lumbar spine (L1-L4)
Values in T-score · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bortezomib/Dexamethasone/Zoledronic Acid1.630.01-3.373.5Not reported
Femoral neck (FN)
Values in T-score · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bortezomib/Dexamethasone/Zoledronic Acid-1.440.01-3.471.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.37
        spread
        0.01
        upper Limit
        3.5
        value
        1.63
    title
    Lumbar spine (L1-L4)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.47
        spread
        0.01
        upper Limit
        1.3
        value
        -1.44
    title
    Femoral neck (FN)
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
BMD of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)
dispersion Type
Full Range
groups
  1. description
    For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles
    id
    OG000
    title
    Bortezomib/Dexamethasone/Zoledronic Acid
param Type
MEDIAN
population Description
Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)
reporting Status
POSTED
time Frame
day 168
title
Bone Mineral Density (BMD)
type
SECONDARY
unit Of Measure
T-score

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

Preserved source evidence · Not medical advice