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Trial record 64 of 315 for:    BENDAMUSTINE

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754402
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Results First Posted : February 27, 2017
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Cristina Gasparetto, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Bendamustine
Drug: Pomalidomide
Drug: Dexamethasone
Enrollment 56
Recruitment Details Recruitment began in January 2013. Dose escalation ended in November, 2013. Expansion enrollment began in December, 2013 and ended in September 2016. Patients were recruited from the Bone Marrow Transplant Clinic and Hematologic Malignancies Clinic at Duke University Medical Center.
Pre-assignment Details Nine patients were consented to the study for cohort 1, however, 3 were screen failures. Seven patients were consented to the study for cohort 2, however, 5 were screen failures. Forty patients were consented to the study for the expansion phase, however, 10 were screen failures.
Arm/Group Title Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Hide Arm/Group Description
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered at the Maximum Tolerated Dose.

Period Title: Overall Study
Started 6 2 30
Completed 4 0 26
Not Completed 2 2 4
Reason Not Completed
Death             0             0             1
Adverse Event             2             2             1
Withdrawal by Subject             0             0             1
Lack of Efficacy             0             0             1
Arm/Group Title Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide Total
Hide Arm/Group Description
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered at the Maximum Tolerated Dose.

Total of all reporting groups
Overall Number of Baseline Participants 6 2 30 38
Hide Baseline Analysis Population Description
Subjects who received drug
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 30 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
2
 100.0%
14
  46.7%
20
  52.6%
>=65 years
2
  33.3%
0
   0.0%
16
  53.3%
18
  47.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 30 participants 38 participants
Female
2
  33.3%
2
 100.0%
17
  56.7%
21
  55.3%
Male
4
  66.7%
0
   0.0%
13
  43.3%
17
  44.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 30 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
2
 100.0%
29
  96.7%
37
  97.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.3%
1
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 30 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  50.0%
5
  16.7%
6
  15.8%
White
6
 100.0%
1
  50.0%
25
  83.3%
32
  84.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 2 participants 30 participants 38 participants
6 2 30 38
1.Primary Outcome
Title Maximum Tolerated Dose of Pomalidomide and Bendamustine
Hide Description

In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.

Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)

If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).

Time Frame 2 cycles (approximately 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.
Arm/Group Title Cohorts 1 and 2
Hide Arm/Group Description:
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)

Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.

Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.

Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: milligrams
Pomalidomide 3
Bendamustine 120
2.Primary Outcome
Title Initial Response Rate
Hide Description

The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:

CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow

PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required

VGPR - Serum and urine M-protein detectable by immunofixation but n

Time Frame 2 cycles (approximately 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.
Arm/Group Title Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Hide Arm/Group Description:
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort.

  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.

Study treatment will be administered at the Maximum Tolerated Dose.

Overall Number of Participants Analyzed 5 0 27
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
  20.0%
11
  40.7%
Very Good Partial Response
0
   0.0%
2
   7.4%
Complete Response
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Overall Response Rate
Hide Description

The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)

sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence

VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h

SD = Not meeting criteria for CR, VGPR, PR, or progressive disease

Time Frame up to 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Progression
Hide Description Time to progression - defined as time elapsed in patients between achievement of response and disease progression
Time Frame up to 2 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Time to Next Therapy
Hide Description Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy
Time Frame up to 2 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Progression Free Survival
Hide Description The time elapsed for patients between initiation of study therapy and either disease progression or death
Time Frame up to 2 years
Outcome Measure Data Not Reported
Time Frame 30 days past last day of drug, up to 1 year
Adverse Event Reporting Description Adverse Events were not collected per cohort, so they are represented as a whole
 
Arm/Group Title Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Hide Arm/Group Description
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
  • Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days
  • Bendamustine: once intravenous (IV) dosing on day 1, every 28 days
  • Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
All-Cause Mortality
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)      2/2 (100.00%)      13/30 (43.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      1/2 (50.00%)      17/30 (56.67%)    
Blood and lymphatic system disorders       
Febrile neutropenia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 4/30 (13.33%)  4
Cardiac disorders       
Atrial fibrillation * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Chest pain - cardiac * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Supraventricular tachycardia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders       
Diarrhea * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders - Other, specify * 1  1/6 (16.67%)  2 0/2 (0.00%)  0 0/30 (0.00%)  0
Mucositis oral * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Nausea * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 1/30 (3.33%)  1
Vomiting * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
General disorders       
Death NOS * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Fever * 1  2/6 (33.33%)  2 1/2 (50.00%)  1 9/30 (30.00%)  9
Infections and infestations       
Bronchial infection * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Infections and infestations - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Lung infection * 1  4/6 (66.67%)  5 0/2 (0.00%)  0 4/30 (13.33%)  4
Urinary tract infection * 1  1/6 (16.67%)  2 0/2 (0.00%)  0 0/30 (0.00%)  0
Sepsis * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
Injury, poisoning and procedural complications       
Fracture * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Postoperative hemorrhage * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Metabolism and nutrition disorders       
Dehydration * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Hypercalcemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Generalized muscle weakness * 1  2/6 (33.33%)  3 0/2 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders       
Syncope * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders       
Confusion * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders - Other, specify * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders       
Cough * 1  2/6 (33.33%)  2 0/2 (0.00%)  0 0/30 (0.00%)  0
Productive cough * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Respiratory failure * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Dyspnea * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Skin and subcutaneous tissue disorders       
Rash maculo-papular * 1  0/6 (0.00%)  0 1/2 (50.00%)  1 0/30 (0.00%)  0
Urticaria * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders       
Hypotension * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Thromboembolic event * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide Cohort 2: 120mg Bendamustine + 4mg Pomalidomide Expansion: 120mg Bendamustine + 3mg Pomalidomide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      2/2 (100.00%)      30/30 (100.00%)    
Blood and lymphatic system disorders       
Anemia * 1  4/6 (66.67%)  5 2/2 (100.00%)  2 23/30 (76.67%)  73
Febrile neutropenia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Cardiac disorders       
Atrial Fibrillation * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Chest pain - cardiac * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 1/30 (3.33%)  1
Cardiac disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Palpitations * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Sinus bradycardia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Sinus tachycardia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Ear and labyrinth disorders       
Ear and labyrinth disorders - Other, specify * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Ear pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Eye disorders       
Eye disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  2
Gastrointestinal disorders       
Abdominal pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Constipation * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 7/30 (23.33%)  11
Diarrhea * 1  2/6 (33.33%)  3 1/2 (50.00%)  1 5/30 (16.67%)  9
Dyspepsia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 6/30 (20.00%)  8
Dysphagia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  2
Gastrointestinal disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Hemorrhoids * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Mucositis oral * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  3
Nausea * 1  1/6 (16.67%)  1 1/2 (50.00%)  1 11/30 (36.67%)  17
Vomiting * 1  0/6 (0.00%)  0 1/2 (50.00%)  1 0/30 (0.00%)  0
General disorders       
Chills * 1  1/6 (16.67%)  2 0/2 (0.00%)  0 1/30 (3.33%)  2
Edema face * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Edema limbs * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 3/30 (10.00%)  3
Fatigue * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 21/30 (70.00%)  46
Fever * 1  1/6 (16.67%)  5 1/2 (50.00%)  1 4/30 (13.33%)  7
Flu like symptoms * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
General disorders and administration site conditions - Other, specify * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 3/30 (10.00%)  7
Irritability * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Localized edema * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Malaise * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Pain * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 1/30 (3.33%)  2
Infections and infestations       
Skin infection * 1  2/6 (33.33%)  4 0/2 (0.00%)  0 0/30 (0.00%)  0
Mucosal infection * 1  0/6 (0.00%)  0 1/2 (50.00%)  1 2/30 (6.67%)  2
Rash pustular * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Tooth infection * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Upper respiratory infection * 1  0/6 (0.00%)  0 1/2 (50.00%)  1 2/30 (6.67%)  2
Urinary tract infection * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Vaginal infection * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Injury, poisoning and procedural complications       
Bruising * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Fall * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  2
Fracture * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Spinal fracture * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Investigations       
Activated partial thromboplastin time prolonged * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  5
Alanine aminotransferase increased * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  5
Alkaline phosphatase increased * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 4/30 (13.33%)  4
Aspartate aminotransferase increased * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 3/30 (10.00%)  8
Blood bilirubin increased * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Creatinine increased * 1  2/6 (33.33%)  2 0/2 (0.00%)  0 8/30 (26.67%)  13
Electrocardiogram QT corrected interval prolonged * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
INR increased * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  8
Investigations - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Lymphocyte count decreased * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 10/30 (33.33%)  22
Neutrophil count decreased * 1  4/6 (66.67%)  9 1/2 (50.00%)  1 26/30 (86.67%)  53
Platelet count decreased * 1  3/6 (50.00%)  6 1/2 (50.00%)  1 20/30 (66.67%)  41
Weight loss * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
White blood cell decreased * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 19/30 (63.33%)  36
Metabolism and nutrition disorders       
Anorexia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 4/30 (13.33%)  4
Hypercalcemia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Hyperglycemia * 1  2/6 (33.33%)  2 0/2 (0.00%)  0 10/30 (33.33%)  23
Hyperkalemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Hypermagnesemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Hyperuricemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Hypoalbuminemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 15/30 (50.00%)  26
Hypocalcemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 15/30 (50.00%)  29
Hypoglycemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  4
Hypokalemia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 14/30 (46.67%)  30
Hypomagnesemia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 18/30 (60.00%)  32
Hyponatremia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 8/30 (26.67%)  20
Hypophosphatemia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 8/30 (26.67%)  11
Iron overload * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Metabolism and nutrition disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 11/30 (36.67%)  19
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
Back pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Bone pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Flank pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Generalized muscle weakness * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  3
Muscle weakness lower limb * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 4/30 (13.33%)  9
Musculoskeletal and connective tissue disorder - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 11/30 (36.67%)  16
Myalgia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  3
Neck pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Pain in extremity * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders       
Dizziness * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Headache * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Lethargy * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders - Other, specify * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Neuralgia * 1  0/6 (0.00%)  0 1/2 (50.00%)  1 0/30 (0.00%)  0
Paresthesia * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 1/30 (3.33%)  1
Peripheral sensory neuropathy * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 5/30 (16.67%)  7
Tremor * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Psychiatric disorders       
Anxiety * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 2/30 (6.67%)  2
Confusion * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 3/30 (10.00%)  4
Depression * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
Insomnia * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 4/30 (13.33%)  4
Renal and urinary disorders       
Acute kidney injury * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Chronic kidney disease * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Hematuria * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Renal and urinary disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Urinary frequency * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Urinary incontinence * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  2
Urinary tract pain * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Urinary urgency * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Reproductive system and breast disorders       
Reproductive system and breast disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Vaginal dryness * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 14/30 (46.67%)  23
Dyspnea * 1  3/6 (50.00%)  4 0/2 (0.00%)  0 15/30 (50.00%)  20
Epistaxis * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Nasal congestion * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 6/30 (20.00%)  9
Productive cough * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 5/30 (16.67%)  11
Respiratory, thoracic and mediastinal disorders - Other, specify * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Wheezing * 1  1/6 (16.67%)  2 0/2 (0.00%)  0 2/30 (6.67%)  4
Skin and subcutaneous tissue disorders       
Dry skin * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  2
Nail loss * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Periorbital edema * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  1
Pruritus * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 0/30 (0.00%)  0
Rash maculo-papular * 1  1/6 (16.67%)  1 0/2 (0.00%)  0 5/30 (16.67%)  5
Skin and subcutaneous tissue disorders - Other, specify * 1  1/6 (16.67%)  2 0/2 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders       
Hot flashes * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 3/30 (10.00%)  3
Hypotension * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 1/30 (3.33%)  2
Thromboembolic event * 1  0/6 (0.00%)  0 0/2 (0.00%)  0 2/30 (6.67%)  4
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cristina Gasparetto, MD
Organization: Duke University Medical Center
Phone: 919-668-1017
EMail: cristina.gasparetto@duke.edu
Layout table for additonal information
Responsible Party: Cristina Gasparetto, Duke University
ClinicalTrials.gov Identifier: NCT01754402     History of Changes
Other Study ID Numbers: Pro00040206
PO-MM-PI-0045 ( Other Identifier: Celgene )
First Submitted: November 27, 2012
First Posted: December 21, 2012
Results First Submitted: December 12, 2016
Results First Posted: February 27, 2017
Last Update Posted: July 25, 2018