Trial Outcomes & Findings for LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma (NCT NCT03773107)
NCT ID: NCT03773107
Last Updated: 2025-01-13
Results Overview
DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
28 days
Results posted on
2025-01-13
Participant Flow
The 10 participants who completed the Phase I component of the trial did not continue to the Phase II component of the trial. This is because the Phase II component of the trial did not open.
Participant milestones
| Measure |
Phase I 5mg Ruxolitinib
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 10 mg Ruxolitinib
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
0
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase I 5mg Ruxolitinib
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 10 mg Ruxolitinib
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|---|
|
Overall Study
Participant currently on study and in follow up status.
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
Baseline characteristics by cohort
| Measure |
Phase II
Cohort A) non-responders to Phase I regimen, Cohort B) responders to Phase I regimen
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 10mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitibin
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
1 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
5 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
3 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
7 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Age subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
1 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
3 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
5 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
2 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
9 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Sex subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
1 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
1 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
4 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
4 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
3 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
11 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=7 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=5 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=4 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
0 Participants
n=21 Participants • Note: the sum of the number of participants who started in the Ethnicity subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=7 Participants • Note: the sum of the number of participants who started in the Region subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
4 participants
n=5 Participants • Note: the sum of the number of participants who started in the Region subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
3 participants
n=4 Participants • Note: the sum of the number of participants who started in the Region subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
12 participants
n=21 Participants • Note: the sum of the number of participants who started in the Region subgroups add up to the total number of participants who started for each of the respective ruxolitinib dose levels.
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Participants who are DLT evaluable
DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=3 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=2 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=3 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)Population: Participants who initiate protocol-directed therapy and have measurable disease at baseline.
Objective response will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of PR or better as per the IMWG criteria
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
2 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)Population: Participants who initiate protocol-directed therapy and have measurable disease at baseline.
Clinical benefit will be determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of minimal response (MR) or better as determined by the IMWG criteria
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Clinical Benefit Rate
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)Population: Number of participants who achieved a disease response of stables disease or better and maintained the response for at least 8 weeks.
Disease control will be determined for each subject as a binary variable indicating whether or not the subject achieved a disease response or stable disease for greater than or equal to 8 weeks
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Disease Control Rate
|
3 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: approx. 5 yearsPopulation: All participants who initiate study treatment.
PFS is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death without progressive disease.
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
6.1 months
Interval 2.6 to 8.3
|
10.6 months
Interval 1.3 to 10.6
|
3.0 months
Interval 1.8 to 3.2
|
SECONDARY outcome
Timeframe: Approximately 180 days after treatment start (disease assessment occurred after every 28-day cycle)Population: Time to best response calculated only for participants who achieved a PR or better.
Time to best response will be defined as the time from initiation of ruxolitinib treatment to the time of best objective status assessment of response.
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=2 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=1 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Time to Best Response
|
3.2 months
Interval 1.8 to 4.6
|
2.1 months
Interval 2.1 to 2.1
|
—
|
SECONDARY outcome
Timeframe: approx. 5 yearsPopulation: All participants who initiate study treatment.
Overall survival is defined as the duration from initiation of ruxolitinib treatment to the date of death from any cause.
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Overall Survival
|
11.2 months
Interval 5.9 to 13.1
|
10.6 months
Interval 1.3 to 19.4
|
16.1 months
Interval 15.9 to 23.5
|
SECONDARY outcome
Timeframe: approx. 5 yearsPopulation: All participants who initiate study treatment.
Time to progression (TTP) is defined as the duration of time from the initiation of study treatment with ruxolitinib to first occurrence of either progressive disease or death.
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=4 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
n=5 Participants
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Time to Progression
|
8.3 months
Interval 4.0 to 8.3
|
10.6 months
Interval 10.6 to 10.6
|
3.0 months
Interval 1.8 to 3.2
|
SECONDARY outcome
Timeframe: approx. 5 yearsPopulation: Duration of best response calculated only for participants who achieved a PR or better.
Duration of response will be defined as the time from first objective status assessment of response to the time of first documented disease progression or death.
Outcome measures
| Measure |
Phase I 10 mg Ruxolitinib
n=2 Participants
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=1 Participants
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 5 mg Ruxolitinib
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Duration of Response
|
4.8 months
Interval 2.2 to 7.4
|
8.5 months
Interval 8.5 to 8.5
|
—
|
Adverse Events
Phase I 5 mg Ruxolitinib
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase I 10 mg Ruxolitinib
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase I 15 mg Ruxolitinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase I 5 mg Ruxolitinib
n=5 participants at risk
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 10 mg Ruxolitinib
n=4 participants at risk
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 participants at risk
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
ALT increase
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Infections and infestations
Hepatitis viral
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
Other adverse events
| Measure |
Phase I 5 mg Ruxolitinib
n=5 participants at risk
Cohort 1) 5mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 10 mg Ruxolitinib
n=4 participants at risk
Cohort 2) 10mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
Phase I 15 mg Ruxolitinib
n=3 participants at risk
Cohort 3) 15mg ruxolitinib
Carfilzomib: Irreversible proteasome inhibitor
Ruxolitinib: Oral JAK inhibitor
Dexamethasone: glucocorticoid
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5 • Number of events 9 • Approximately 5 years
|
100.0%
4/4 • Number of events 26 • Approximately 5 years
|
66.7%
2/3 • Number of events 10 • Approximately 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Approximately 5 years
|
50.0%
2/4 • Number of events 2 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Investigations
ALT increase
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 3 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
AST increase
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Investigations
Creatinine increased
|
60.0%
3/5 • Number of events 3 • Approximately 5 years
|
25.0%
1/4 • Number of events 3 • Approximately 5 years
|
33.3%
1/3 • Number of events 2 • Approximately 5 years
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Number of events 3 • Approximately 5 years
|
75.0%
3/4 • Number of events 3 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
Ejection fraction decreased
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 2 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Approximately 5 years
|
50.0%
2/4 • Number of events 2 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Gastrointestinal disorders
Fever
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 2 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
33.3%
1/3 • Number of events 2 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 2 • Approximately 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 4 • Approximately 5 years
|
|
Gastrointestinal disorders
Malaise
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 2 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Number of events 3 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 20 • Approximately 5 years
|
75.0%
3/4 • Number of events 9 • Approximately 5 years
|
66.7%
2/3 • Number of events 7 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
40.0%
2/5 • Number of events 2 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
20.0%
1/5 • Number of events 2 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Soar throat
|
20.0%
1/5 • Number of events 2 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/5 • Approximately 5 years
|
50.0%
2/4 • Number of events 2 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Investigations
Urine output decreased
|
0.00%
0/5 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
33.3%
1/3 • Number of events 1 • Approximately 5 years
|
|
Investigations
Weight loss
|
20.0%
1/5 • Number of events 1 • Approximately 5 years
|
0.00%
0/4 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • Approximately 5 years
|
25.0%
1/4 • Number of events 1 • Approximately 5 years
|
0.00%
0/3 • Approximately 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place