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Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00609167
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : December 7, 2010
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone
Enrollment 63
Recruitment Details Sixty-three(63) participants were recruited between December 2006 and October 2008 at either Mayo Clinic Arizona or Princess Margaret Hospital.
Pre-assignment Details  
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Period Title: Overall Study
Started 33 30
Completed 25 23
Not Completed 8 7
Reason Not Completed
Withdrawal by Subject             1             0
Lack of Efficacy             1             0
Adverse Event             5             1
Disease Progression             1             0
Stem Cell Transplant             0             6
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2) Total
Hide Arm/Group Description

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Total of all reporting groups
Overall Number of Baseline Participants 33 30 63
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants 30 participants 63 participants
60
(38 to 75)
61
(36 to 70)
61
(36 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
Female
16
  48.5%
14
  46.7%
30
  47.6%
Male
17
  51.5%
16
  53.3%
33
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
United States 12 12 24
Canada 21 18 39
Parameters of Hematologic Response - Serum M-spike >=1g/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
Yes 25 18 43
No 8 12 20
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >=10mg/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
Yes 24 26 50
No 9 4 13
Parameter of Hematologic Response - Urine M-Spike >= 200mg/24 hours  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
Yes 16 11 27
No 17 19 36
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 30 participants 63 participants
Yes 23 22 45
No 10 8 18
1.Primary Outcome
Title Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment
Hide Description

Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.

Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.

near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.

Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.

Time Frame After 4 months of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 30
Measure Type: Number
Unit of Measure: participants
20 18
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description

PFS was defined as the time from registration to progression or death due to any cause.

Progression was defined as any one or more of the following:

An increase of 25% from lowest confirmed response in:

  • Serum M-component (absolute increase >= 0.5g/dl)
  • Urine M-component (absolute increase >= 200mg/24hour
  • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
  • Bone marrow plasma cell percentage (absolute increase of >=10%)
  • Definite development of new bone lesion or soft tissue plasmacytomas
Time Frame up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 30
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
The median PFS for group 1 has not been attained.
[2]
The median PFS for group 2 has not been attained
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from registration to death of any cause.
Time Frame From date of registration until death (up to 5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 30
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Median OS for group 1 has not been attained.
[2]
Median OS for group 2 has not been attained.
4.Secondary Outcome
Title Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles
Hide Description

Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.

CR, nCR and VGPR as defined in the primary outcome.

Partial Response(PR): >=50% reduction in serum M-component and/or

Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

Time Frame 4 cycles
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received 4 cycles of treatment were analyzed.
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 30
Measure Type: Number
Unit of Measure: participants
29 28
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.
Time Frame Duration of study (up to 12 cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a partial response(PR) or better were evaluable for this analysis.
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 29 28
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Median duration of response for group 1 was not attained.
[2]
Median duration of response for group 2 was not attained.
6.Secondary Outcome
Title Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles
Hide Description

Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.

Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.

Time Frame After 8 cycles of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received 8 cycles of treatment were analyzed.
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 0 2
Measure Type: Number
Unit of Measure: participants
1
7.Secondary Outcome
Title Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles
Hide Description

Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.

Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.

Time Frame After 12 cycles of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Severe Adverse Events
Hide Description Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Time Frame Every cycle during treatment (up to 12 cycles)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 30
Measure Type: Number
Unit of Measure: participants
16 11
9.Secondary Outcome
Title Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant
Hide Description Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.
Time Frame After 4 cycles of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
At the time of publication, data was available on 18 patients for group 2.
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description:

Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO days 1-4, 9-12, 17-20

Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22

Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22

Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22

Overall Number of Participants Analyzed 33 18
Measure Type: Number
Unit of Measure: participants
33 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Hide Arm/Group Description Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20 Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
All-Cause Mortality
CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/33 (12.12%)      3/30 (10.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/33 (3.03%)  1 1/30 (3.33%)  1
Gastrointestinal disorders     
Colonic obstruction  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Infections and infestations     
Blood Infection  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Lung (pneumonia) infection  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Investigations     
Neutrophil count decreased  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcemia  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Hyponatremia  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Pneumonitis  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Pulmonary  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders     
Thrombosis  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CyBorD (Bortezomib 1.3mg/m^2) CyBorD (Bortezomib 1.5mg/m^2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/33 (100.00%)      27/30 (90.00%)    
Blood and lymphatic system disorders     
Anemia  1  4/33 (12.12%)  6 2/30 (6.67%)  2
Hemolysis  1  0/33 (0.00%)  0 2/30 (6.67%)  4
Cardiac disorders     
Ischemia/Infarction  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Sinus tachycardia  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders     
Constipation  1  2/33 (6.06%)  3 1/30 (3.33%)  1
Diarrhea  1  0/33 (0.00%)  0 3/30 (10.00%)  5
Dyspepsia  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Ileus  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Nausea  1  0/33 (0.00%)  0 3/30 (10.00%)  3
Vomiting  1  0/33 (0.00%)  0 1/30 (3.33%)  1
General disorders     
Edema limbs  1  1/33 (3.03%)  1 3/30 (10.00%)  4
Fatigue  1  18/33 (54.55%)  52 24/30 (80.00%)  75
Infections and infestations     
Bronchus infection  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Conjunctiva infection  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Infection without neutropenia  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Upper airway infection  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Alkaline phosphatase increased  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Creatinine increased  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Metabolic/Lab  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Neutrophil count decreased  1  14/33 (42.42%)  30 7/30 (23.33%)  16
Platelet count decreased  1  27/33 (81.82%)  68 11/30 (36.67%)  28
Metabolism and nutrition disorders     
Hyperglycemia  1  6/33 (18.18%)  7 0/30 (0.00%)  0
Hyperkalemia  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Hypocalcemia  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Hypokalemia  1  2/33 (6.06%)  2 0/30 (0.00%)  0
Hyponatremia  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Hypophosphatemia  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Bone pain  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Muscle Weakness  1  2/33 (6.06%)  2 0/30 (0.00%)  0
Musculoskeletal  1  1/33 (3.03%)  2 0/30 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Ischemia cerebrovascular  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Peripheral sensory neuropathy  1  21/33 (63.64%)  52 17/30 (56.67%)  64
Taste  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Tremor  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Anxiety  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Euphoria  1  1/33 (3.03%)  2 0/30 (0.00%)  0
Insomnia  1  3/33 (9.09%)  4 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Cough  1  1/33 (3.03%)  1 2/30 (6.67%)  2
Dyspnea  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Hiccups  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Pneumonitis  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Pulmonary  1  1/33 (3.03%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Erythema multiforme  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders     
Hypertension  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Hypotension  1  0/33 (0.00%)  0 1/30 (3.33%)  1
Thrombosis  1  2/33 (6.06%)  2 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. A. Keith Stewart
Organization: Mayo Clinic
Responsible Party: Alexander Keith Stewart, M.B.Ch.B, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00609167     History of Changes
Other Study ID Numbers: CDR0000583225
P30CA015083 ( U.S. NIH Grant/Contract )
MC0686 ( Other Identifier: Macyo Clinic Cancer Center )
06-002613 ( Other Identifier: Mayo Clinic IRB )
NCI-2010-02147 ( Registry Identifier: NCI-CTRP )
First Submitted: January 31, 2008
First Posted: February 6, 2008
Results First Submitted: November 5, 2010
Results First Posted: December 7, 2010
Last Update Posted: May 17, 2011