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NCT03477539 · OUTCOME

Incidence of Adverse Events

Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma · Source last updated 2026-05-05

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

Measure
NUMBER
Unit
percent of participants
Interval / dispersion
Not reported
Time frame
3 years

What was measured

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percent of patients that reported a grade 3 or higher adverse events according to CTCAE criteria is reported.

Groups in this outcome

Treatment (Daratumumab, ASCT, Lenalidomide)

Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.

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 (Daratumumab, ASCT, Lenalidomide)49

Reported measurements

Source class 1
Values in percent of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Daratumumab, ASCT, Lenalidomide)90Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        90
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percent of patients that reported a grade 3 or higher adverse events according to CTCAE criteria is reported.
groups
  1. description
    Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Daratumumab, ASCT, Lenalidomide)
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice