NCT02099539 · OUTCOME

Disease Response Rate of Treated Patients

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Starts at Week 11 - 12 and Week 23 - 24

What was measured

CR- negative SIFE and UIFE, disappearance of any soft tissue plasmacytomas, and \< or = to 5% plasma cells in bone marrow VGPR - either + SIFE and UIFE and - SPEP and UPEP or reduction in serum M-protein \> or = to 90% and urine m-protein level \<100mg per 24h PR - if measurable serum an urine m-protein them reduction of serum m-protein by \>=50% and reduction in 24h urinary m protein by \>=90% or to \<200mg per 24h if unmeasurable serum and urine m-protein then \>= 50% decrease in the difference between involve and uninvolved FLC levels If unmeasurable serum and urine m-protein and serum FLC assay then \>= 50% reduction in plasma cells, provide baseline bone marrow plasma cell percentage was \>=30% In addition to the above listed criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required PD - defined via International Myeloma Working Group uniform response criteria: disease progression SD - not meeting criteria for CR, VGPR, PR or PD

Analysis population: Cohort 5: N-803 - SQ 10 ug/kg - one subject only received 2 doses of study drug. This subject is not evaluable for tumor response assessment. Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects

Groups in this outcome

Cohort 1: N-803 - IV 1 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 2: N-803 - IV 3 ug/kg

Cohort 3: N-803 - IV 6 ug/kg

Cohort 4: N-803 - IV 10 ug/kg

Cohort 5: N-803 - SQ 10 ug/kg

Cohort 6: N-803 - SQ 15 ug/kg

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 1: N-803 - IV 1 ug/kg	3
Cohort 2: N-803 - IV 3 ug/kg	3
Cohort 3: N-803 - IV 6 ug/kg	3
Cohort 4: N-803 - IV 10 ug/kg	3
Cohort 5: N-803 - SQ 10 ug/kg	3
Cohort 6: N-803 - SQ 15 ug/kg	3

Reported measurements

Source class 1

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	0	Not reported	Not reported	Not reported	Not reported
Cohort 2: N-803 - IV 3 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 3: N-803 - IV 6 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 4: N-803 - IV 10 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 5: N-803 - SQ 10 ug/kg	0	Not reported	Not reported	Not reported	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	1	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	3	Not reported	Not reported	Not reported	Not reported
Cohort 2: N-803 - IV 3 ug/kg	2	Not reported	Not reported	Not reported	Not reported
Cohort 3: N-803 - IV 6 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 4: N-803 - IV 10 ug/kg	2	Not reported	Not reported	Not reported	Not reported
Cohort 5: N-803 - SQ 10 ug/kg	2	Not reported	Not reported	Not reported	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	2	Not reported	Not reported	Not reported	Not reported

Not available to evaluate

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	0	Not reported	Not reported	Not reported	Not reported
Cohort 2: N-803 - IV 3 ug/kg	0	Not reported	Not reported	Not reported	Not reported
Cohort 3: N-803 - IV 6 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 4: N-803 - IV 10 ug/kg	0	Not reported	Not reported	Not reported	Not reported
Cohort 5: N-803 - SQ 10 ug/kg	1	Not reported	Not reported	Not reported	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
1
title
Stable Disease
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
2
title
Progressive Disease
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
title
Not available to evaluate

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
3
units
Participants

description

groups

description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG000
title
Cohort 1: N-803 - IV 1 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG001
title
Cohort 2: N-803 - IV 3 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG002
title
Cohort 3: N-803 - IV 6 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG003
title
Cohort 4: N-803 - IV 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG004
title
Cohort 5: N-803 - SQ 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG005
title
Cohort 6: N-803 - SQ 15 ug/kg

param Type

COUNT_OF_PARTICIPANTS

population Description

Cohort 5: N-803 - SQ 10 ug/kg - one subject only received 2 doses of study drug. This subject is not evaluable for tumor response assessment. Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects

reporting Status

POSTED

time Frame

Starts at Week 11 - 12 and Week 23 - 24

title

Disease Response Rate of Treated Patients

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice