Trial Outcomes & Findings for Trial of Romidepsin and Bortezomib for Multiple Myeloma (NCT NCT00765102)
NCT ID: NCT00765102
Last Updated: 2019-11-25
Results Overview
Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \<5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: \>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. Stable Disease: Less than MR, but not PD Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
TERMINATED
PHASE2
32 participants
up to 8 months
2019-11-25
Participant Flow
Stratum 1 (bortezomib resistant) had 19 participants. Stratum 2 (non-bortezomib resistant) had 13 participants.
Participant milestones
| Measure |
Romidepsin + Bortezomib
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Romidepsin + Bortezomib
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
|---|---|
|
Overall Study
Progressive disease
|
18
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Trial of Romidepsin and Bortezomib for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Romidepsin + Bortezomib
n=32 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 0
|
12 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 1
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status 2
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 monthsPopulation: Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.
Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \<5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: \>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other. Stable Disease: Less than MR, but not PD Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 9 monthsPopulation: Safety population of participants who took at least one dose of drug.
Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=32 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 TEAE
|
32 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 drug-related TEAE
|
30 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 Romidepsin-related TEAE
|
28 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 Bortezomib-related TEAE
|
30 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 >=Grade 3 TEAE
|
28 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 Grade 4 TEAE
|
5 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 serious TEAE
|
14 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 TEAE leading to discontinuation
|
6 participants
|
—
|
|
Participants With Treatment-emergent Adverse Events (TEAEs)
At least 1 TEAE leading to death
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
|
1209.1 ng*hr/mL
Geometric Coefficient of Variation 29.4
|
1149.5 ng*hr/mL
Geometric Coefficient of Variation 22.2
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
Maximum observed concentration of Romidepsin
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
913.9 ng/mL
Geometric Coefficient of Variation 21.4
|
1002.7 ng/mL
Geometric Coefficient of Variation 20.6
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
Time to maximum observed concentration of Romidepsin
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Time to Maximum Observed Concentration (Tmax)
|
1.04 hr
Interval 0.6 to 1.1
|
0.58 hr
Interval 0.53 to 0.67
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
Terminal half-life of Romidepsin
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Terminal Half-life (t1/2)
|
4.1 hr
Geometric Coefficient of Variation 11.0
|
3.6 hr
Geometric Coefficient of Variation 41.7
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
Total clearance of Romidepsin
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Total Clearance (CL)
|
11.3 L/hr
Geometric Coefficient of Variation 26.9
|
16.4 L/hr
Geometric Coefficient of Variation 31.5
|
SECONDARY outcome
Timeframe: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusionPopulation: A subset of participants from the lead investigator's site had PK samples taken.
Total volume of distribution of Romidepsin
Outcome measures
| Measure |
Romidepsin + Bortezomib
n=6 Participants
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
Romidepsin 10 mg/m^2 + Bortezomib
n=5 Participants
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
|
|---|---|---|
|
Total Volume of Distribution (Vz)
|
66.5 L
Geometric Coefficient of Variation 23.4
|
85.9 L
Geometric Coefficient of Variation 66.8
|
SECONDARY outcome
Timeframe: up to month 8Population: Intent to treat population. Analysis was not performed due to early termination of the study.
Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator. Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to month 8Population: Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response). Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \<5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: \>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to month 8Population: Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Duration of response is defined as the time from first response to progressive disease as assessed by the investigator. Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to month 8Population: Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first. Progressive Disease(PD):\>25% increase in serum monoclonal paraprotein, or \>25% plasma cells in marrow, or \>25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia. Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, \>= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to month 8Population: Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Overall survival is the time from initiation of therapy to death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
Romidepsin + Bortezomib
Serious adverse events
| Measure |
Romidepsin + Bortezomib
n=32 participants at risk
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • up to 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32 • up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • up to 9 months
|
|
General disorders
Asthenia
|
6.2%
2/32 • up to 9 months
|
|
General disorders
Pyrexia
|
3.1%
1/32 • up to 9 months
|
|
Immune system disorders
Hypersensitivity
|
3.1%
1/32 • up to 9 months
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • up to 9 months
|
|
Infections and infestations
Pneumonia primary atypical
|
3.1%
1/32 • up to 9 months
|
|
Infections and infestations
Pneumonia staphylococcal
|
3.1%
1/32 • up to 9 months
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • up to 9 months
|
|
Infections and infestations
Septic shock
|
6.2%
2/32 • up to 9 months
|
|
Infections and infestations
Urosepsis
|
3.1%
1/32 • up to 9 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
6.2%
2/32 • up to 9 months
|
|
Investigations
Electrocardiogram T wave inversion
|
3.1%
1/32 • up to 9 months
|
|
Investigations
Electrocardiogram QT prolongation
|
3.1%
1/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
2/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
1/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
3.1%
1/32 • up to 9 months
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • up to 9 months
|
|
Nervous system disorders
Hemiparesis
|
3.1%
1/32 • up to 9 months
|
|
Renal and urinary disorders
Renal failure acute
|
6.2%
2/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
1/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.1%
1/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.1%
1/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.1%
1/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.1%
1/32 • up to 9 months
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • up to 9 months
|
|
Vascular disorders
Venous thrombosis
|
3.1%
1/32 • up to 9 months
|
Other adverse events
| Measure |
Romidepsin + Bortezomib
n=32 participants at risk
Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.
Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.6%
13/32 • up to 9 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
2/32 • up to 9 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.6%
13/32 • up to 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
65.6%
21/32 • up to 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • up to 9 months
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
6.2%
2/32 • up to 9 months
|
|
Gastrointestinal disorders
Constipation
|
31.2%
10/32 • up to 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
9/32 • up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
16/32 • up to 9 months
|
|
Gastrointestinal disorders
Vomiting
|
28.1%
9/32 • up to 9 months
|
|
General disorders
Asthenia
|
6.2%
2/32 • up to 9 months
|
|
General disorders
Fatigue
|
43.8%
14/32 • up to 9 months
|
|
General disorders
Infusion site erythema
|
6.2%
2/32 • up to 9 months
|
|
General disorders
Malaise
|
6.2%
2/32 • up to 9 months
|
|
General disorders
Oedema peripheral
|
9.4%
3/32 • up to 9 months
|
|
General disorders
Pain
|
6.2%
2/32 • up to 9 months
|
|
General disorders
Pyrexia
|
25.0%
8/32 • up to 9 months
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • up to 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • up to 9 months
|
|
Infections and infestations
Urinary tract infection
|
12.5%
4/32 • up to 9 months
|
|
Investigations
White blood cell count decreased
|
6.2%
2/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
9.4%
3/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
4/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
4/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
4/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
2/32 • up to 9 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
2/32 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
2/32 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
4/32 • up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
3/32 • up to 9 months
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • up to 9 months
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • up to 9 months
|
|
Nervous system disorders
Headache
|
31.2%
10/32 • up to 9 months
|
|
Nervous system disorders
Neuropathy
|
9.4%
3/32 • up to 9 months
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
2/32 • up to 9 months
|
|
Renal and urinary disorders
Renal failure
|
12.5%
4/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
6/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
2/32 • up to 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
2/32 • up to 9 months
|
|
Vascular disorders
Flushing
|
6.2%
2/32 • up to 9 months
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • up to 9 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation
- Publication restrictions are in place
Restriction type: OTHER