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NCT02654990 · OUTCOME

VGPR Rate

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma · Source last updated 2024-07-12

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
Up to 5.2 years

What was measured

VGPR, based on IMWG criteria per blinded IRC assessment, is defined as: serum and/or urine M protein detectable by immunofixation but not on protein electrophoresis, or ≥90% reduction from baseline in serum) and urine M protein \<100 milligrams/24 hours); in the case of the presence of any soft tissue plasmacytoma(s) at baseline, a reduction in the sum of the products of the cross-diameters by ≥50% from baseline is required; in case the only measurable disease in a participant at baseline is the serum FLC level (that is, no measurable disease in serum and urine PEP), a decrease of \>90% in the difference between involved and uninvolved FLC levels from baseline is required. Results reported as percentage of participants achieving VGPR.

Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.

Groups in this outcome

Arm A - Panobinostat (20 mg, TIW)

Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm B - Panobinostat (20 mg, BIW)

Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm C - Panobinostat (10 mg, TIW)

Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

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

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)82
Arm B - Panobinostat (20 mg, BIW)83
Arm C - Panobinostat (10 mg, TIW)83

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)19.5Not reportedNot reportedNot reportedNot reported
Arm B - Panobinostat (20 mg, BIW)25.3Not reportedNot reportedNot reportedNot reported
Arm C - Panobinostat (10 mg, TIW)20.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19.5
      2. group Id
        OG001
        value
        25.3
      3. group Id
        OG002
        value
        20.5
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      83
    3. group Id
      OG002
      value
      83
    units
    Participants
description
VGPR, based on IMWG criteria per blinded IRC assessment, is defined as: serum and/or urine M protein detectable by immunofixation but not on protein electrophoresis, or ≥90% reduction from baseline in serum) and urine M protein \<100 milligrams/24 hours); in the case of the presence of any soft tissue plasmacytoma(s) at baseline, a reduction in the sum of the products of the cross-diameters by ≥50% from baseline is required; in case the only measurable disease in a participant at baseline is the serum FLC level (that is, no measurable disease in serum and urine PEP), a decrease of \>90% in the difference between involved and uninvolved FLC levels from baseline is required. Results reported as percentage of participants achieving VGPR.
groups
  1. description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG000
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG001
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG002
    title
    Arm C - Panobinostat (10 mg, TIW)
param Type
NUMBER
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
reporting Status
POSTED
time Frame
Up to 5.2 years
title
VGPR Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice