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NCT04756401 · OUTCOME

Rate of Minimal Residual Disease (MRD) Negative Status

Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma · Source last updated 2026-09-15

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
Up to 5 years post-treatment

What was measured

MRD negative status at 10\^-5 level of sensitivity by flow cytometry will be considered synonymous with "success", unless specified otherwise. The proportion of success will be estimated by the number of success divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Analysis population: Flow cytometry was not performed on collected samples and will never be performed due to early trial closure. Therefore, MRD is able to be assessed for 0 patients.

Groups in this outcome

Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Carfilzomib: Given IV \> \> Daratumumab: Given IV \> \> Dexamethasone: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Selinexor: Given PO

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 (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)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
MRD negative status at 10\^-5 level of sensitivity by flow cytometry will be considered synonymous with "success", unless specified otherwise. The proportion of success will be estimated by the number of success divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
groups
  1. description
    Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15 and daratumumab IV on days 1 and 2 of cycle 1 then days 8, 15, and 22 of cycle 1, then, days 1, 8, 15, and 22 of cycle 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8 15, and 22, and selinexor PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Carfilzomib: Given IV \> \> Daratumumab: Given IV \> \> Dexamethasone: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> Selinexor: Given PO
    id
    OG000
    title
    Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)
population Description
Flow cytometry was not performed on collected samples and will never be performed due to early trial closure. Therefore, MRD is able to be assessed for 0 patients.
reporting Status
POSTED
time Frame
Up to 5 years post-treatment
title
Rate of Minimal Residual Disease (MRD) Negative Status
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice