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Trial of Romidepsin and Bortezomib for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00765102
Recruitment Status : Terminated (There was a change in the Sponsor's research strategy; safety concerns were not a factor.)
First Posted : October 2, 2008
Results First Posted : December 20, 2012
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Bortezomib
Drug: Romidepsin
Enrollment 32
Recruitment Details  
Pre-assignment Details Stratum 1 (bortezomib resistant) had 19 participants. Stratum 2 (non-bortezomib resistant) had 13 participants.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 32
Completed 1 [1]
Not Completed 31
Reason Not Completed
Progressive disease             18
Adverse Event             6
Physician Decision             4
Withdrawal by Subject             2
Protocol Violation             1
[1]
Completed 8 cycles of treatment
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description

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 Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
63.7  (8.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
18
  56.3%
Male
14
  43.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Asian 2
Native Hawaiian or Other Pacific Islander 2
Black or African American 2
White 24
Other 2
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Status 0 12
Status 1 14
Status 2 6
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare.
1.Primary Outcome
Title Count of Participant Best Overall Response As Assessed by the Investigator
Hide Description

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.

Time Frame up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who took at least one dose of drug.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
At least 1 TEAE 32
At least 1 drug-related TEAE 30
At least 1 Romidepsin-related TEAE 28
At least 1 Bortezomib-related TEAE 30
At least 1 >=Grade 3 TEAE 28
At least 1 Grade 4 TEAE 5
At least 1 serious TEAE 14
At least 1 TEAE leading to discontinuation 6
At least 1 TEAE leading to death 2
3.Secondary Outcome
Title Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0–∞)
Hide Description 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.
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
1209.1
(29.4%)
1149.5
(22.2%)
4.Secondary Outcome
Title Maximum Observed Concentration (Cmax)
Hide Description Maximum observed concentration of Romidepsin
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
913.9
(21.4%)
1002.7
(20.6%)
5.Secondary Outcome
Title Time to Maximum Observed Concentration (Tmax)
Hide Description Time to maximum observed concentration of Romidepsin
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Median (Full Range)
Unit of Measure: hr
1.04
(0.60 to 1.10)
0.58
(0.53 to 0.67)
6.Secondary Outcome
Title Terminal Half-life (t1/2)
Hide Description Terminal half-life of Romidepsin
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr
4.1
(11.0%)
3.6
(41.7%)
7.Secondary Outcome
Title Total Clearance (CL)
Hide Description Total clearance of Romidepsin
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/hr
11.3
(26.9%)
16.4
(31.5%)
8.Secondary Outcome
Title Total Volume of Distribution (Vz)
Hide Description Total volume of distribution of Romidepsin
Time Frame 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 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the lead investigator's site had PK samples taken.
Arm/Group Title Romidepsin 8 mg/m^2 + Bortezomib Romidepsin 10 mg/m^2 + Bortezomib
Hide Arm/Group Description:
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 8mg/m^2.
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.
Overall Number of Participants Analyzed 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
66.5
(23.4%)
85.9
(66.8%)
9.Secondary Outcome
Title Kaplan Meier Estimate for Time to Progression Assessed by the Investigator
Hide Description

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.

Time Frame up to month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Analysis was not performed due to early termination of the study.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Kaplan Meier Estimate for Time to Response Assessed by the Investigator
Hide Description

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.

Time Frame up to month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Kaplan Meier Estimate for Duration of Response Assessed by the Investigator
Hide Description

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.

Time Frame up to month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator
Hide Description

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.

Time Frame up to month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Kaplan Meier Estimates for Overall Survival
Hide Description Overall survival is the time from initiation of therapy to death from any cause.
Time Frame up to month 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Romidepsin + Bortezomib
Hide Arm/Group Description

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.

All-Cause Mortality
Romidepsin + Bortezomib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Romidepsin + Bortezomib
Affected / at Risk (%)
Total   14/32 (43.75%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/32 (3.13%) 
Thrombocytopenia  1  1/32 (3.13%) 
Gastrointestinal disorders   
Vomiting  1  1/32 (3.13%) 
General disorders   
Asthenia  1  2/32 (6.25%) 
Pyrexia  1  1/32 (3.13%) 
Immune system disorders   
Hypersensitivity  1  1/32 (3.13%) 
Infections and infestations   
Pneumonia  1  2/32 (6.25%) 
Pneumonia primary atypical  1  1/32 (3.13%) 
Pneumonia staphylococcal  1  1/32 (3.13%) 
Sepsis  1  2/32 (6.25%) 
Septic shock  1  2/32 (6.25%) 
Urosepsis  1  1/32 (3.13%) 
Injury, poisoning and procedural complications   
Subdural haematoma  1  2/32 (6.25%) 
Investigations   
Electrocardiogram T wave inversion  1  1/32 (3.13%) 
Electrocardiogram QT prolongation  1  1/32 (3.13%) 
Metabolism and nutrition disorders   
Dehydration  1  1/32 (3.13%) 
Hypercalcaemia  1  2/32 (6.25%) 
Hypokalemia  1  1/32 (3.13%) 
Malnutrition  1  1/32 (3.13%) 
Nervous system disorders   
Headache  1  1/32 (3.13%) 
Hemiparesis  1  1/32 (3.13%) 
Renal and urinary disorders   
Renal failure acute  1  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/32 (3.13%) 
Acute respiratory failure  1  1/32 (3.13%) 
Asthma  1  1/32 (3.13%) 
Chronic obstructive pulmonary disease  1  1/32 (3.13%) 
Pneumonia aspiration  1  1/32 (3.13%) 
Vascular disorders   
Hypotension  1  1/32 (3.13%) 
Venous thrombosis  1  1/32 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Romidepsin + Bortezomib
Affected / at Risk (%)
Total   32/32 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  13/32 (40.63%) 
Leukopenia  1  2/32 (6.25%) 
Neutropenia  1  13/32 (40.63%) 
Thrombocytopenia  1  21/32 (65.63%) 
Gastrointestinal disorders   
Abdominal pain  1  2/32 (6.25%) 
Aphthous stomatitis  1  2/32 (6.25%) 
Constipation  1  10/32 (31.25%) 
Diarrhoea  1  9/32 (28.13%) 
Nausea  1  16/32 (50.00%) 
Vomiting  1  9/32 (28.13%) 
General disorders   
Asthenia  1  2/32 (6.25%) 
Fatigue  1  14/32 (43.75%) 
Infusion site erythema  1  2/32 (6.25%) 
Malaise  1  2/32 (6.25%) 
Oedema peripheral  1  3/32 (9.38%) 
Pain  1  2/32 (6.25%) 
Pyrexia  1  8/32 (25.00%) 
Infections and infestations   
Sinusitis  1  2/32 (6.25%) 
Upper respiratory tract infection  1  2/32 (6.25%) 
Urinary tract infection  1  4/32 (12.50%) 
Investigations   
White blood cell count decreased  1  2/32 (6.25%) 
Metabolism and nutrition disorders   
Anorexia  1  3/32 (9.38%) 
Hypercalcaemia  1  4/32 (12.50%) 
Hypokalaemia  1  4/32 (12.50%) 
Hypomagnesaemia  1  4/32 (12.50%) 
Hyponatraemia  1  2/32 (6.25%) 
Hypophosphataemia  1  2/32 (6.25%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/32 (9.38%) 
Muscle spasms  1  2/32 (6.25%) 
Musculoskeletal pain  1  4/32 (12.50%) 
Pain in extremity  1  3/32 (9.38%) 
Nervous system disorders   
Dizziness  1  3/32 (9.38%) 
Dysgeusia  1  3/32 (9.38%) 
Headache  1  10/32 (31.25%) 
Neuropathy  1  3/32 (9.38%) 
Neuropathy peripheral  1  2/32 (6.25%) 
Renal and urinary disorders   
Renal failure  1  4/32 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/32 (18.75%) 
Dyspnoea  1  3/32 (9.38%) 
Hypoxia  1  2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  2/32 (6.25%) 
Rash macular  1  2/32 (6.25%) 
Vascular disorders   
Flushing  1  2/32 (6.25%) 
Hypertension  1  2/32 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00765102     History of Changes
Other Study ID Numbers: GPI-08-0006
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: September 26, 2012
Results First Posted: December 20, 2012
Last Update Posted: May 4, 2016