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NCT04205240 · OUTCOME

Number of Patients With a Partial Response

Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma · Source last updated 2023-09-28

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

Measure
NUMBER
Unit
patients
Interval / dispersion
Not reported
Time frame
Approximately 11 months

What was measured

The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution.

Groups in this outcome

Treatment (Conditioning Regimen, Stem Cell Transplant)

Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Conditioning Regimen, Stem Cell Transplant)1

Reported measurements

Source class 1
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Conditioning Regimen, Stem Cell Transplant)1Not 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
      1
    units
    Participants
description
The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution.
groups
  1. description
    Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation Cyclophosphamide: Given IV Daratumumab: Given IV Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given PO or IV
    id
    OG000
    title
    Treatment (Conditioning Regimen, Stem Cell Transplant)
param Type
NUMBER
reporting Status
POSTED
time Frame
Approximately 11 months
title
Number of Patients With a Partial Response
type
SECONDARY
unit Of Measure
patients

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

Preserved source evidence · Not medical advice