NCT03477539 · OUTCOME

Progression-free Survival

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: 95% Confidence Interval
Time frame: 3 years

What was measured

The distribution of progression-free survival will be estimated using the Kaplan-Meier method. The percent of patients alive and disease free at 3 years 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

Group	Source count
Treatment (Daratumumab, ASCT, Lenalidomide)	46

Reported measurements

Source class 1

Values in percent of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment (Daratumumab, ASCT, Lenalidomide)	92.6	Not reported	84.7	100	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
84.7
upper Limit
100
value
92.6

denoms

counts
group Id
OG000
value
46
units
Participants

description

The distribution of progression-free survival will be estimated using the Kaplan-Meier method. The percent of patients alive and disease free at 3 years is reported.

dispersion Type

95% Confidence Interval

groups

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

Progression-free Survival

type

SECONDARY

unit Of Measure

percent of participants

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

Preserved source evidence · Not medical advice