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NCT01215344 · OUTCOME

The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).

First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade · Source last updated 2018-05-15

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
95% Confidence Interval
Time frame
6-months post ASCT

What was measured

Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.

Analysis population: Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.

Groups in this outcome

VELCADE, Lenalidomide, Dexamethasone (VRD)

VELCADE, Lenalidomide, Dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle Lenalidomide: 25 mg by mouth on days 1-4 of each cycle Dexamethasone: 20 mg the day before and the day after receiving VELCADE DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.

VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)

VELCADE, liposomal doxorubicin, dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4

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

Analysis denominator · Participants

GroupSource count
VELCADE, Lenalidomide, Dexamethasone (VRD)20
VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)0

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
VELCADE, Lenalidomide, Dexamethasone (VRD)30Not reported1160Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11
        upper Limit
        60
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.
dispersion Type
95% Confidence Interval
groups
  1. description
    VELCADE, Lenalidomide, Dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle Lenalidomide: 25 mg by mouth on days 1-4 of each cycle Dexamethasone: 20 mg the day before and the day after receiving VELCADE DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Bisphosphonates: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
    id
    OG000
    title
    VELCADE, Lenalidomide, Dexamethasone (VRD)
  2. description
    VELCADE, liposomal doxorubicin, dexamethasone VELCADE: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle DVT prophylaxis: At least one asprin 81 mg per day. Other option per physician's choice Liposomal doxorubicin: 30 mg/m2 on day 4 of each cycle Dexamethasone: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
    id
    OG001
    title
    VELCADE, Liposomal Doxorubicin, Dexamethasone (VDD)
param Type
NUMBER
population Description
Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.
reporting Status
POSTED
time Frame
6-months post ASCT
title
The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice