NCT02685826 · OUTCOME

Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Time to Maximum Observed Concentration (Tmax)

A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2023-10-06

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

Measure: MEDIAN
Unit: day
Interval / dispersion: Full Range
Time frame: pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1

What was measured

Time to maximum observed concentration of Durvalumab (DURVA) after multiple doses on day 1 obtained from the observed concentration versus time data

Analysis population: The PK Population included participants who received \>=1 dose of study treatment and had \>=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.

Groups in this outcome

Cohort A: High Risk, TNE

High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.

Cohort B: >=65 Years Old, TNE

\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.

Cohort C: High Risk, Post-transplant

High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.

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
Cohort A: High Risk, TNE	23
Cohort B: >=65 Years Old, TNE	10
Cohort C: High Risk, Post-transplant	20

Reported measurements

Source class 1

Values in day · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Cohort A: High Risk, TNE	0.051	Not reported	0.04	0.22	Not reported
Cohort B: >=65 Years Old, TNE	0.106	Not reported	0.04	0.22	Not reported
Cohort C: High Risk, Post-transplant	0.180	Not reported	0.04	0.22	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.04
upper Limit
0.22
value
0.051
group Id
OG001
lower Limit
0.04
upper Limit
0.22
value
0.106
group Id
OG002
lower Limit
0.04
upper Limit
0.22
value
0.180

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
10
group Id
OG002
value
20
units
Participants

description

Time to maximum observed concentration of Durvalumab (DURVA) after multiple doses on day 1 obtained from the observed concentration versus time data

dispersion Type

Full Range

groups

description
High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
id
OG000
title
Cohort A: High Risk, TNE
description
\>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
id
OG001
title
Cohort B: >=65 Years Old, TNE
description
High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
id
OG002
title
Cohort C: High Risk, Post-transplant

param Type

MEDIAN

population Description

The PK Population included participants who received \>=1 dose of study treatment and had \>=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.

reporting Status

POSTED

time Frame

pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1

title

Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Time to Maximum Observed Concentration (Tmax)

type

SECONDARY

unit Of Measure

day

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Preserved source evidence · Not medical advice