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NCT02057640 · OUTCOME

Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708)

MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma · Source last updated 2019-12-11

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
4 months (102 days)

What was measured

Response to intervention as measured by international uniform response criteria and clinical benefit response according to modified EBMT response criteria, comparing myeloma panels obtained at the beginning of each cycle that include SPEP, 24 h UPEP, serum and urine IFEs, and serum free light chains to results at screening. In addition a baseline bone marrow exam and skeletal survey will be obtained and repeated as clinically indicated and for assessment of complete remission (bone marrow)

Groups in this outcome

DL1 - 3mg Lxazomib

Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28

DL2 - 4mg Lxazomib

Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28

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

Analysis denominator · Participants

GroupSource count
DL1 - 3mg Lxazomib4
DL2 - 4mg Lxazomib12

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DL1 - 3mg Lxazomib0Not reportedNot reportedNot reportedNot reported
DL2 - 4mg Lxazomib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Response to intervention as measured by international uniform response criteria and clinical benefit response according to modified EBMT response criteria, comparing myeloma panels obtained at the beginning of each cycle that include SPEP, 24 h UPEP, serum and urine IFEs, and serum free light chains to results at screening. In addition a baseline bone marrow exam and skeletal survey will be obtained and repeated as clinically indicated and for assessment of complete remission (bone marrow)
groups
  1. description
    Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
    id
    OG000
    title
    DL1 - 3mg Lxazomib
  2. description
    Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
    id
    OG001
    title
    DL2 - 4mg Lxazomib
param Type
NUMBER
reporting Status
POSTED
time Frame
4 months (102 days)
title
Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice