Trial Outcomes & Findings for Melphalan and Panobinostat (LBH589) for the Treatment of Patients With Recurrent Multiple Myeloma (NCT NCT00743288)
NCT ID: NCT00743288
Last Updated: 2014-05-08
Results Overview
Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
12 months
Results posted on
2014-05-08
Participant Flow
This is a multicenter study
Participant milestones
| Measure |
Melphalan and Panobinostat Schedule A
10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
|
Melphalan and Panobinostat Schedule B1
10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B2
20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule C
20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule D1
15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
Melphalan and Panobinostat Schedule D2
15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
Melphalan and Panobinostat Schedule D3
20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
7
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
7
|
6
|
5
|
9
|
Reasons for withdrawal
| Measure |
Melphalan and Panobinostat Schedule A
10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
|
Melphalan and Panobinostat Schedule B1
10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B2
20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule C
20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule D1
15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
Melphalan and Panobinostat Schedule D2
15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
Melphalan and Panobinostat Schedule D3
20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
2
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Progressive disease (PD)
|
2
|
0
|
1
|
4
|
5
|
3
|
6
|
|
Overall Study
Worsening of condition (Not PD)
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Melphalan and Panobinostat (LBH589) for the Treatment of Patients With Recurrent Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Melphalan and Panobinostat (LBH589)
n=40 Participants
Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
|
|---|---|
|
Age, Continuous
|
65.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
Prior regimens
Number of prior regimens
|
4 number of prior regimens
n=5 Participants
|
|
Prior regimens
Number of Bortezomib-containing prior regimens
|
2 number of prior regimens
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.
Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study
Outcome measures
| Measure |
Melphalan and Panobinostat Schedule B
n=6 Participants
B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat Schedule C
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
|
Melphalan and Panobinostat Schedule D
Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat All Patients
Data for all patients irrespective of dosage
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
20 mg LBH589
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPhase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study
Outcome measures
| Measure |
Melphalan and Panobinostat Schedule B
n=6 Participants
B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat Schedule C
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
|
Melphalan and Panobinostat Schedule D
Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat All Patients
Data for all patients irrespective of dosage
|
|---|---|---|---|---|---|
|
MTD
|
0.05 mg/kg melphalan
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 monthsResponses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.
Outcome measures
| Measure |
Melphalan and Panobinostat Schedule B
n=3 Participants
B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B
n=9 Participants
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat Schedule C
n=7 Participants
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
|
Melphalan and Panobinostat Schedule D
n=21 Participants
Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat All Patients
n=40 Participants
Data for all patients irrespective of dosage
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
CR
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
VGPR
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
PR
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
MR
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
SD (stable disease)
|
1 participants
|
5 participants
|
5 participants
|
12 participants
|
23 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
Progressive disease (PD)
|
2 participants
|
1 participants
|
2 participants
|
9 participants
|
14 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
ORR (CR+VGPR+ PR)
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan
CBR (ORR+MR)
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or deathPopulation: Only three patients had responses.
Outcome measures
| Measure |
Melphalan and Panobinostat Schedule B
n=3 Participants
B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat Schedule C
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
|
Melphalan and Panobinostat Schedule D
Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat All Patients
Data for all patients irrespective of dosage
|
|---|---|---|---|---|---|
|
Duration of Response
|
8.1 months
Interval 0.0 to 17.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from the start of treatment to progressive diseasePopulation: All cohorts were analyzed
Outcome measures
| Measure |
Melphalan and Panobinostat Schedule B
n=40 Participants
B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.
|
Melphalan and Panobinostat Schedule B
Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.
B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat Schedule C
0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
|
Melphalan and Panobinostat Schedule D
Schedules D1, D2 and D3
D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1
|
Melphalan and Panobinostat All Patients
Data for all patients irrespective of dosage
|
|---|---|---|---|---|---|
|
Time to Progression
|
1.6 months
Interval 0.6 to 2.7
|
—
|
—
|
—
|
—
|
Adverse Events
Melphalan and Panobinostat
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Melphalan and Panobinostat
n=40 participants at risk
Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
|
|---|---|
|
Injury, poisoning and procedural complications
Vertebral compression fracture
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Infections and infestations
Gram-negative sepsis
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Vascular disorders
Deep vein thrombosis with oulmonary embolism
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Altered mental status
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypecalcemia
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Melphalan and Panobinostat
n=40 participants at risk
Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.
Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia (>=grade 3)
|
15.0%
6/40 • Number of events 6 • 24 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
6/40 • Number of events 6 • 24 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.5%
9/40 • Number of events 9 • 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.5%
11/40 • Number of events 11 • 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
10/40 • Number of events 10 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
2/40 • Number of events 2 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place