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NCT03303950 · OUTCOME

Number of Participants With Different Clinical Responses

Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis · Source last updated 2022-05-05

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
Up to 1 year

What was measured

Clinical Responses were determined by disease-specific criteria taking into account multiple clinical and molecular markers. Multiple Myeloma (MM) response was determined using International Myeloma Working Group (IMWG) consensus criteria for response. Participants with MM had either Stringent Complete Response (sCR) or Very Good Partial Response (VGPR). Myelofibrosis (MF) response was determined using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus criteria. Participants with MF had either Complete Response (CR) or Stable Disease (SD) (also referred to in the protocol as no response).

Analysis population: one participant was not evaluable due to failure to engraft (no response assessments performed)

Groups in this outcome

All Particpants - Treatment

Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.

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

Analysis denominator · Participants

GroupSource count
All Particpants - Treatment5

Reported measurements

Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Particpants - Treatment1Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Particpants - Treatment1Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Particpants - Treatment2Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Particpants - Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stringent Complete Response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Very Good Partial Response (VGPR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Complete Response (CR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stable Disease (SD)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Clinical Responses were determined by disease-specific criteria taking into account multiple clinical and molecular markers. Multiple Myeloma (MM) response was determined using International Myeloma Working Group (IMWG) consensus criteria for response. Participants with MM had either Stringent Complete Response (sCR) or Very Good Partial Response (VGPR). Myelofibrosis (MF) response was determined using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus criteria. Participants with MF had either Complete Response (CR) or Stable Disease (SD) (also referred to in the protocol as no response).
groups
  1. description
    Participants receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic stem cell transplant (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
    id
    OG000
    title
    All Particpants - Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
one participant was not evaluable due to failure to engraft (no response assessments performed)
reporting Status
POSTED
time Frame
Up to 1 year
title
Number of Participants With Different Clinical Responses
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice