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NCT03187262 · OUTCOME

Number of Participants With Complete Response

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
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
COUNT_OF_PARTICIPANTS
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
2 years
title
Number of Participants With Complete Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice