NCT03201250 · OUTCOME

Overall Response Rate (ORR)

Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma · Source last updated 2023-09-08

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: 2 cycles (approximately 56 days)

What was measured

Per International Myeloma Working Group (IMWG) Uniform Response Criteria guidelines as assessed by laboratory blood tests: Complete Response (CR), negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow; Stringent Complete Response (sCR), same as CR plus normal serum free light chain (FLC) ratio and absence of clonal plasma cells; Very Good Partial Response (VGPR), serum and urine M-component still detectable by immunofixation or \>/= 90% reduction in serum M-component plus a urine M component of, 100mg per 24hrs; Partial Response (PR) ≥ 50% reduction of the serum M-protein and 24 hour urinary M-protein by ≥ 90%, or to \< 200 mg per 24 hours. If serum and urine M-protein are not measurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required OR If FLC is also not informative, ≥ 50% reduction in bone marrow plasma. ORR includes following only: CR+sCR+VGPR+PR

Analysis population: Two subjects were not included in this analysis as the protocol states that an individual must complete at least 2 cycles before a best response (ORR) could be established.

Groups in this outcome

Level -1 = 20 mg

Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)

Level 0 = 40 mg

Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)

Level +1 = 60 mg

Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)

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
Level -1 = 20 mg	3
Level 0 = 40 mg	3
Level +1 = 60 mg	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Level -1 = 20 mg	1	Not reported	Not reported	Not reported	Not reported
Level 0 = 40 mg	0	Not reported	Not reported	Not reported	Not reported
Level +1 = 60 mg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
0
units
Participants

description

groups

description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
OG000
title
Level -1 = 20 mg
description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
OG001
title
Level 0 = 40 mg
description
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
id
OG002
title
Level +1 = 60 mg

param Type

COUNT_OF_PARTICIPANTS

population Description

Two subjects were not included in this analysis as the protocol states that an individual must complete at least 2 cycles before a best response (ORR) could be established.

reporting Status

POSTED

time Frame

2 cycles (approximately 56 days)

title

Overall Response Rate (ORR)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice