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NCT01207765 · OUTCOME

Safety and Efficacy

Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma · Source last updated 2017-03-20

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Through day +104 following immunotherapy

What was measured

Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.

Analysis population: 6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety

Groups in this outcome

Zevalin

90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.

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

Analysis denominator · Participants

GroupSource count
Zevalin8

Reported measurements

CR/PR at +12 days

Analysis denominator · Participants

GroupSource count
Zevalin6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zevalin1Not reportedNot reportedNot reportedNot reported
CR/PR at +104 days

Analysis denominator · Participants

GroupSource count
Zevalin6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zevalin5Not reportedNot reportedNot reportedNot reported
Participants with toxic events

Analysis denominator · Participants

GroupSource count
Zevalin8
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zevalin5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    CR/PR at +12 days
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    CR/PR at +104 days
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Participants with toxic events
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.
groups
  1. description
    90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
    id
    OG000
    title
    Zevalin
param Type
NUMBER
population Description
6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety
reporting Status
POSTED
time Frame
Through day +104 following immunotherapy
title
Safety and Efficacy
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice