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NCT01125293 · OUTCOME

Phase II Duration of Response (DoR)

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia · Source last updated 2021-04-23

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Patients were assessed for disease every cycle while on treatment (168 days) and every three months while on maintenance therapy. In long-term follow-up, disease was monitored every 3 months. Study cohort median (range) follow-up was 15 (1 - 23) months.

What was measured

The DoR is defined as the elapsed time from date when the measurement criteria are first met for a complete or partial response (whichever status is recorded first) until the date of first observation of objective disease progression. Analysis of DoR will be as follows: * For responding patients who die without objective PD (including death from study disease), DoR will be censored at the date of the last objective progression-free disease assessment. * For responding patients not known to have died as of the data cut-off date and who do not have objective PD, DoR will be censored at the date of the last objective progression-free disease assessment. * For responding patients who receive subsequent systemic anticancer therapy (after discontinuation from the study chemotherapy) prior to objectively determined disease progression, DoR will be censored at the date of the last objective progression-free disease assessment prior to post discontinuation therapy.

Groups in this outcome

Phase II

Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)

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

Analysis denominator · Participants

GroupSource count
Phase II23

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase II14Not reported123Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        23
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The DoR is defined as the elapsed time from date when the measurement criteria are first met for a complete or partial response (whichever status is recorded first) until the date of first observation of objective disease progression. Analysis of DoR will be as follows: * For responding patients who die without objective PD (including death from study disease), DoR will be censored at the date of the last objective progression-free disease assessment. * For responding patients not known to have died as of the data cut-off date and who do not have objective PD, DoR will be censored at the date of the last objective progression-free disease assessment. * For responding patients who receive subsequent systemic anticancer therapy (after discontinuation from the study chemotherapy) prior to objectively determined disease progression, DoR will be censored at the date of the last objective progression-free disease assessment prior to post discontinuation therapy.
dispersion Type
Full Range
groups
  1. description
    Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
    id
    OG000
    title
    Phase II
param Type
MEDIAN
reporting Status
POSTED
time Frame
Patients were assessed for disease every cycle while on treatment (168 days) and every three months while on maintenance therapy. In long-term follow-up, disease was monitored every 3 months. Study cohort median (range) follow-up was 15 (1 - 23) months.
title
Phase II Duration of Response (DoR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice