Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04205240 · OUTCOME

Rate of Minimal Residual Disease-negativity

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline up to 365 days post-transplant

What was measured

Will be defined as the proportion of patients who achieved minimal residual disease-negative status at the respective time point, in accordance with the International Myeloma Working Group criteria. Minimal residual disease was evaluated by next-generation sequencing using ClonoSEQ Assay.

Analysis population: Due to low patient accrual to study unable to collect and analyze data

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)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Will be defined as the proportion of patients who achieved minimal residual disease-negative status at the respective time point, in accordance with the International Myeloma Working Group criteria. Minimal residual disease was evaluated by next-generation sequencing using ClonoSEQ Assay.
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)
population Description
Due to low patient accrual to study unable to collect and analyze data
reporting Status
POSTED
time Frame
Baseline up to 365 days post-transplant
title
Rate of Minimal Residual Disease-negativity
type
OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice