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NCT02399085 · OUTCOME

Serum Drug Levels of MOR00208

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL · Source last updated 2023-10-23

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

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment

What was measured

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

Analysis population: PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration. Number analyzed includes only participants with data at each timepoint.

Groups in this outcome

Tafasitamab (MOR00208) + Lenalidomide (LEN)

MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

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
Tafasitamab (MOR00208) + Lenalidomide (LEN)	81

Reported measurements

Cycle 1 Day 1 (Predose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	79

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	6.7	53.09	Not reported	Not reported	Not reported

Cycle 1 Day 1 (1 hour post dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	71

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	249075.9	53724.93	Not reported	Not reported	Not reported

Cycle 1 Day 4 (pre-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	73

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	126306.8	39105.37	Not reported	Not reported	Not reported

Cycle 1 Day 4 (1 hour post-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	65

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	363626.2	82971.54	Not reported	Not reported	Not reported

Cycle 1 Day 15 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	75

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	157722.3	50655.86	Not reported	Not reported	Not reported

Cycle 1 Day 15 (1 hour post-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	70

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	396262.1	97215.09	Not reported	Not reported	Not reported

Cycle 2 Day 1 (predose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	71

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	181870.8	72582.62	Not reported	Not reported	Not reported

Cycle 2 Day 1 (1 hour post-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	62

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	439788.2	126930.55	Not reported	Not reported	Not reported

Cycle 2 Day 15 (Pre Dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	63

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	217846.9	77799.93	Not reported	Not reported	Not reported

Cycle 2 Day 15 (1 hour post-dose) )

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	59

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	442940.2	85475.90	Not reported	Not reported	Not reported

Cycle 3 Day 1 (predose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	61

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	208520.6	68866.46	Not reported	Not reported	Not reported

Cycle 3 Day 1 (1 hour post-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	53

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	466135.8	112647.31	Not reported	Not reported	Not reported

Cycle 3 Day 15 (predose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	51

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	223909.4	85170.91	Not reported	Not reported	Not reported

Cycle 3 Day 15 (1 hour post-dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	44

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	455635.0	104198.64	Not reported	Not reported	Not reported

Cycle 4 Day 1 (predose) )

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	52

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	216328.4	94553.25	Not reported	Not reported	Not reported

Cycle 5 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	51

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	142134.4	72691.16	Not reported	Not reported	Not reported

Cycle 6 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	49

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	115132.3	55774.77	Not reported	Not reported	Not reported

Cycle 7 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	49

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	114661.5	73328.15	Not reported	Not reported	Not reported

Cycle 9 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	40

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	108640.4	52282.72	Not reported	Not reported	Not reported

Cycle 11 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	34

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	126472.0	64872.47	Not reported	Not reported	Not reported

Cycle 13 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	31

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	100853.5	61229.42	Not reported	Not reported	Not reported

Cycle 15 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	30

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	159676.5	61199.32	Not reported	Not reported	Not reported

Cycle 17 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	25

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	175855.1	64592.17	Not reported	Not reported	Not reported

Cycle 19 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	21

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	197045.0	69962.05	Not reported	Not reported	Not reported

Cycle 21 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	19

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	197228.0	53222.03	Not reported	Not reported	Not reported

Cycle 23 Day 1 (pre dose)

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	15

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	224253.3	64686.85	Not reported	Not reported	Not reported

End of Treatment

Analysis denominator · Participants

Group	Source count
Tafasitamab (MOR00208) + Lenalidomide (LEN)	39

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Tafasitamab (MOR00208) + Lenalidomide (LEN)	141240.7	114804.40	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
53.09
value
6.7
denoms
counts
group Id
OG000
value
79
units
Participants
title
Cycle 1 Day 1 (Predose)
categories
measurements
group Id
OG000
spread
53724.93
value
249075.9
denoms
counts
group Id
OG000
value
71
units
Participants
title
Cycle 1 Day 1 (1 hour post dose)
categories
measurements
group Id
OG000
spread
39105.37
value
126306.8
denoms
counts
group Id
OG000
value
73
units
Participants
title
Cycle 1 Day 4 (pre-dose)
categories
measurements
group Id
OG000
spread
82971.54
value
363626.2
denoms
counts
group Id
OG000
value
65
units
Participants
title
Cycle 1 Day 4 (1 hour post-dose)
categories
measurements
group Id
OG000
spread
50655.86
value
157722.3
denoms
counts
group Id
OG000
value
75
units
Participants
title
Cycle 1 Day 15 (pre dose)
categories
measurements
group Id
OG000
spread
97215.09
value
396262.1
denoms
counts
group Id
OG000
value
70
units
Participants
title
Cycle 1 Day 15 (1 hour post-dose)
categories
measurements
group Id
OG000
spread
72582.62
value
181870.8
denoms
counts
group Id
OG000
value
71
units
Participants
title
Cycle 2 Day 1 (predose)
categories
measurements
group Id
OG000
spread
126930.55
value
439788.2
denoms
counts
group Id
OG000
value
62
units
Participants
title
Cycle 2 Day 1 (1 hour post-dose)
categories
measurements
group Id
OG000
spread
77799.93
value
217846.9
denoms
counts
group Id
OG000
value
63
units
Participants
title
Cycle 2 Day 15 (Pre Dose)
categories
measurements
group Id
OG000
spread
85475.90
value
442940.2
denoms
counts
group Id
OG000
value
59
units
Participants
title
Cycle 2 Day 15 (1 hour post-dose) )
categories
measurements
group Id
OG000
spread
68866.46
value
208520.6
denoms
counts
group Id
OG000
value
61
units
Participants
title
Cycle 3 Day 1 (predose)
categories
measurements
group Id
OG000
spread
112647.31
value
466135.8
denoms
counts
group Id
OG000
value
53
units
Participants
title
Cycle 3 Day 1 (1 hour post-dose)

denoms

counts
group Id
OG000
value
81
units
Participants

description

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

dispersion Type

Standard Deviation

groups

description
MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
id
OG000
title
Tafasitamab (MOR00208) + Lenalidomide (LEN)

param Type

MEAN

population Description

PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration. Number analyzed includes only participants with data at each timepoint.

reporting Status

POSTED

time Frame

Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment

title

Serum Drug Levels of MOR00208

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice