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NCT01383759 · OUTCOME

To Estimate the Hematologic Response Rate

Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis · Source last updated 2020-04-07

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

\[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.

Groups in this outcome

Amyloidosis

Participants with newly diagnosed AL amyloidosis

Monoclonal Ig DepositionDisease (MIDD)

Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)

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

Analysis denominator · Participants

GroupSource count
Amyloidosis19
Monoclonal Ig DepositionDisease (MIDD)1

Reported measurements

Source class 1

Complete Response (CR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amyloidosis7Not reportedNot reportedNot reportedNot reported
Monoclonal Ig DepositionDisease (MIDD)0Not reportedNot reportedNot reportedNot reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amyloidosis4Not reportedNot reportedNot reportedNot reported
Monoclonal Ig DepositionDisease (MIDD)0Not reportedNot reportedNot reportedNot reported

Progression of Disease (POD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amyloidosis1Not reportedNot reportedNot reportedNot reported
Monoclonal Ig DepositionDisease (MIDD)0Not reportedNot reportedNot reportedNot reported

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amyloidosis1Not reportedNot reportedNot reportedNot reported
Monoclonal Ig DepositionDisease (MIDD)0Not reportedNot reportedNot reportedNot reported

Very Good Partial Response (VGPR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amyloidosis6Not reportedNot reportedNot reportedNot reported
Monoclonal Ig DepositionDisease (MIDD)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      title
      Complete Response (CR)
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      title
      Partial Response (PR)
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Progression of Disease (POD)
    4. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Stable Disease (SD)
    5. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      title
      Very Good Partial Response (VGPR)
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      1
    units
    Participants
description
\[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.
groups
  1. description
    Participants with newly diagnosed AL amyloidosis
    id
    OG000
    title
    Amyloidosis
  2. description
    Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
    id
    OG001
    title
    Monoclonal Ig DepositionDisease (MIDD)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
To Estimate the Hematologic Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice