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NCT01438177 · OUTCOME

Response Rate (CR + PR After 2 Cycles)

Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma · Source last updated 2020-02-24

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 2 years

What was measured

Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h

Analysis population: Evaluable patients.

Groups in this outcome

Velcade+Cyclophosphamide+Chloroquine

VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35. Chloroquine given at 500 mg orally daily on days 1-14 and 22-35. Each cycle is 42 days in length.

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+Cyclophosphamide+Chloroquine9

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade+Cyclophosphamide+Chloroquine30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h
groups
  1. description
    VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35. Chloroquine given at 500 mg orally daily on days 1-14 and 22-35. Each cycle is 42 days in length.
    id
    OG000
    title
    Velcade+Cyclophosphamide+Chloroquine
param Type
NUMBER
population Description
Evaluable patients.
reporting Status
POSTED
time Frame
Up to 2 years
title
Response Rate (CR + PR After 2 Cycles)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice