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NCT03187262 · OUTCOME

Progression Free Survival

A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia · Source last updated 2022-11-23

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
4 years

What was measured

Amount of time following daratumumab administration until \>25% increase in serum IgM

Analysis population: Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.

Groups in this outcome

Daratumumab

* Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories

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

Analysis denominator · Participants

GroupSource count
Daratumumab11

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Daratumumab2Not reported128Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        28
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Amount of time following daratumumab administration until \>25% increase in serum IgM
dispersion Type
Full Range
groups
  1. description
    * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
    id
    OG000
    title
    Daratumumab
param Type
MEDIAN
population Description
Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
reporting Status
POSTED
time Frame
4 years
title
Progression Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice