Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00075881 · OUTCOME

Response Rate on Induction

Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2014-06-02

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
90% Confidence Interval
Time frame
participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days

What was measured

Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.

Analysis population: 42 eligible and treated patients were included in the analysis.

Groups in this outcome

PS-341

Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles. Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15 Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.

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

Analysis denominator · Participants

GroupSource count
PS-34142

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
PS-34147.6Not reported34.261.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.2
        upper Limit
        61.3
        value
        47.6
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.
dispersion Type
90% Confidence Interval
groups
  1. description
    Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles. Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15 Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
    id
    OG000
    title
    PS-341
param Type
NUMBER
population Description
42 eligible and treated patients were included in the analysis.
reporting Status
POSTED
time Frame
participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days
title
Response Rate on Induction
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice