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Trial record 10 of 23 for:    "Al Amyloidosis" | "Cyclophosphamide"

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

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: NCT00064337
Recruitment Status : Completed
First Posted : July 9, 2003
Results First Posted : November 6, 2017
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Plasma Cell Myeloma
Interventions Biological: filgrastim
Drug: cyclophosphamide
Drug: dexamethasone
Drug: melphalan
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

filgrastim

cyclophosphamide

dexamethasone

melphalan

thalidomide

peripheral blood

Period Title: PBSCC or Induction/PBSCC
Started 93 [1]
Completed 73
Not Completed 20
Reason Not Completed
Not protocol-specified             7
Adverse Event             6
Progression             3
Patient Refusal             2
Death             2
[1]
104 patients were registered, 93 of whom were eligible and analyzable.
Period Title: Transplant
Started 67 [1]
Completed 46
Not Completed 21
Reason Not Completed
Adverse Event             9
Not protocol-specified             5
Death             3
Patient Refusal             2
Progression             2
[1]
6 patients who completed PBSCC or Induction/PBSCC did not begin Transplant
Period Title: Maintenance
Started 13 [1]
Completed 3
Not Completed 10
Reason Not Completed
Adverse Event             3
Progression             2
On treatment at time of analysis             2
Not protocol-specified             2
Death             1
[1]
Only patients with High Risk MM or AL + MM were allowed to enroll to Maintenance treatment.
Arm/Group Title Treatment
Hide Arm/Group Description

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

filgrastim

cyclophosphamide

dexamethasone

melphalan

thalidomide

peripheral blood

Overall Number of Baseline Participants 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 93 participants
65
(33 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants
Female
35
  37.6%
Male
58
  62.4%
1.Primary Outcome
Title Overall Survival
Hide Description Time from initial registration until death or date of last contact, whichever occurs first, for up to 5 years from the date of the last patient registration.
Time Frame 5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients only.
Arm/Group Title Treatment
Hide Arm/Group Description:

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

filgrastim

cyclophosphamide

dexamethasone

melphalan

thalidomide

peripheral blood

Overall Number of Participants Analyzed 93
Median (95% Confidence Interval)
Unit of Measure: Months
68 [1] 
(42 to NA)
[1]
The upper limit of the 95% CI for the median had not yet been reached at time of analysis.
2.Secondary Outcome
Title Hematologic Response
Hide Description [Not Specified]
Time Frame Until off study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection:

MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
8
  34.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PBSCC or Induction/PBSCC Autologous Transplants Dex/Thal
Hide Arm/Group Description Induction/PBSCC – High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition; PBSCC - Light Chain Amyloidosis/Light Chain Disposition Autologous Transplants � All patients Dex/Thal - High Risk MM or MM with Light Chain Amyloidosis/Light Chain Disposition
All-Cause Mortality
PBSCC or Induction/PBSCC Autologous Transplants Dex/Thal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PBSCC or Induction/PBSCC Autologous Transplants Dex/Thal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/92 (4.35%)   3/65 (4.62%)   1/12 (8.33%) 
Cardiac disorders       
Cardiac General-Other  1  1/92 (1.09%)  0/65 (0.00%)  0/12 (0.00%) 
Cardiac-ischemia/infarction  1  0/92 (0.00%)  1/65 (1.54%)  0/12 (0.00%) 
Left ventricular diastolic dysfunction  1  1/92 (1.09%)  0/65 (0.00%)  0/12 (0.00%) 
SVT and nodal arrhythmia - Nodal/junctional  1  0/92 (0.00%)  1/65 (1.54%)  0/12 (0.00%) 
General disorders       
Constitutional Symptoms-Other  1  1/92 (1.09%)  1/65 (1.54%)  0/12 (0.00%) 
Investigations       
Cardiac troponin I (cTnI)  1  0/92 (0.00%)  1/65 (1.54%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death - Disease progression NOS  1  0/92 (0.00%)  0/65 (0.00%)  1/12 (8.33%) 
Renal and urinary disorders       
Renal failure  1  1/92 (1.09%)  0/65 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PBSCC or Induction/PBSCC Autologous Transplants Dex/Thal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   83/92 (90.22%)   62/65 (95.38%)   12/12 (100.00%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  2/92 (2.17%)  20/65 (30.77%)  0/12 (0.00%) 
Hemoglobin  1  43/92 (46.74%)  48/65 (73.85%)  6/12 (50.00%) 
Lymphatics-Other  1  5/92 (5.43%)  8/65 (12.31%)  0/12 (0.00%) 
Cardiac disorders       
Cardiac Arrhythmia-Other  1  1/92 (1.09%)  12/65 (18.46%)  0/12 (0.00%) 
Cardiac General-Other  1  5/92 (5.43%)  7/65 (10.77%)  0/12 (0.00%) 
Ear and labyrinth disorders       
Auditory/Ear-Other  1  1/92 (1.09%)  0/65 (0.00%)  1/12 (8.33%) 
Endocrine disorders       
Cushingoid appearance  1  2/92 (2.17%)  0/65 (0.00%)  1/12 (8.33%) 
Eye disorders       
Dry eye syndrome  1  0/92 (0.00%)  2/65 (3.08%)  1/12 (8.33%) 
Ocular/Visual-Other  1  2/92 (2.17%)  2/65 (3.08%)  1/12 (8.33%) 
Vision-blurred vision  1  2/92 (2.17%)  4/65 (6.15%)  2/12 (16.67%) 
Gastrointestinal disorders       
Constipation  1  20/92 (21.74%)  13/65 (20.00%)  3/12 (25.00%) 
Diarrhea  1  13/92 (14.13%)  41/65 (63.08%)  1/12 (8.33%) 
Distention/bloating, abdominal  1  0/92 (0.00%)  6/65 (9.23%)  0/12 (0.00%) 
Dry mouth/salivary gland (xerostomia)  1  2/92 (2.17%)  11/65 (16.92%)  0/12 (0.00%) 
Dysphagia (difficulty swallowing)  1  1/92 (1.09%)  4/65 (6.15%)  0/12 (0.00%) 
Esophagitis  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Heartburn/dyspepsia  1  4/92 (4.35%)  6/65 (9.23%)  1/12 (8.33%) 
Hemorrhage, GI - Lower GI NOS  1  0/92 (0.00%)  0/65 (0.00%)  1/12 (8.33%) 
Hemorrhoids  1  0/92 (0.00%)  5/65 (7.69%)  0/12 (0.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  2/92 (2.17%)  13/65 (20.00%)  0/12 (0.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Nausea  1  28/92 (30.43%)  44/65 (67.69%)  1/12 (8.33%) 
Pain - Abdomen NOS  1  5/92 (5.43%)  9/65 (13.85%)  0/12 (0.00%) 
Vomiting  1  18/92 (19.57%)  29/65 (44.62%)  0/12 (0.00%) 
General disorders       
Edema: limb  1  22/92 (23.91%)  19/65 (29.23%)  2/12 (16.67%) 
Extremity-lower (gait/walking)  1  3/92 (3.26%)  1/65 (1.54%)  2/12 (16.67%) 
Fatigue (asthenia, lethargy, malaise)  1  41/92 (44.57%)  41/65 (63.08%)  7/12 (58.33%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  5/92 (5.43%)  20/65 (30.77%)  0/12 (0.00%) 
Pain-Other  1  2/92 (2.17%)  2/65 (3.08%)  1/12 (8.33%) 
Rigors/chills  1  2/92 (2.17%)  7/65 (10.77%)  0/12 (0.00%) 
Immune system disorders       
Allergic reaction/hypersensitivity  1  0/92 (0.00%)  4/65 (6.15%)  1/12 (8.33%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/92 (1.09%)  5/65 (7.69%)  0/12 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  1/92 (1.09%)  0/65 (0.00%)  1/12 (8.33%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter  1  1/92 (1.09%)  4/65 (6.15%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  3/92 (3.26%)  3/65 (4.62%)  3/12 (25.00%) 
Inf w/unknown ANC - Middle ear (otitis media)  1  0/92 (0.00%)  0/65 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications       
Bruising (in absence of Gr 3-4 thrombocytopenia)  1  2/92 (2.17%)  7/65 (10.77%)  0/12 (0.00%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  7/92 (7.61%)  14/65 (21.54%)  0/12 (0.00%) 
AST, SGOT  1  6/92 (6.52%)  16/65 (24.62%)  1/12 (8.33%) 
Alkaline phosphatase  1  23/92 (25.00%)  23/65 (35.38%)  0/12 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  4/92 (4.35%)  10/65 (15.38%)  1/12 (8.33%) 
Cholesterol, serum-high (hypercholesterolemia)  1  0/92 (0.00%)  5/65 (7.69%)  0/12 (0.00%) 
Creatinine  1  21/92 (22.83%)  30/65 (46.15%)  5/12 (41.67%) 
GGT (gamma-glutamyl transpeptidase)  1  1/92 (1.09%)  10/65 (15.38%)  0/12 (0.00%) 
INR (of prothrombin time)  1  2/92 (2.17%)  3/65 (4.62%)  1/12 (8.33%) 
Leukocytes (total WBC)  1  18/92 (19.57%)  47/65 (72.31%)  5/12 (41.67%) 
Lymphopenia  1  9/92 (9.78%)  11/65 (16.92%)  2/12 (16.67%) 
Metabolic/Laboratory-Other  1  4/92 (4.35%)  5/65 (7.69%)  0/12 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  10/92 (10.87%)  46/65 (70.77%)  3/12 (25.00%) 
PTT (Partial thromboplastin time)  1  1/92 (1.09%)  5/65 (7.69%)  0/12 (0.00%) 
Platelets  1  43/92 (46.74%)  49/65 (75.38%)  3/12 (25.00%) 
Weight gain  1  6/92 (6.52%)  3/65 (4.62%)  2/12 (16.67%) 
Weight loss  1  1/92 (1.09%)  13/65 (20.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  24/92 (26.09%)  32/65 (49.23%)  1/12 (8.33%) 
Anorexia  1  17/92 (18.48%)  24/65 (36.92%)  1/12 (8.33%) 
Bicarbonate, serum-low  1  3/92 (3.26%)  5/65 (7.69%)  0/12 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  16/92 (17.39%)  31/65 (47.69%)  2/12 (16.67%) 
Dehydration  1  4/92 (4.35%)  9/65 (13.85%)  0/12 (0.00%) 
Glucose, serum-high (hyperglycemia)  1  33/92 (35.87%)  33/65 (50.77%)  6/12 (50.00%) 
Magnesium, serum-high (hypermagnesemia)  1  2/92 (2.17%)  5/65 (7.69%)  0/12 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  8/92 (8.70%)  9/65 (13.85%)  0/12 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  5/92 (5.43%)  11/65 (16.92%)  1/12 (8.33%) 
Potassium, serum-high (hyperkalemia)  1  4/92 (4.35%)  9/65 (13.85%)  2/12 (16.67%) 
Potassium, serum-low (hypokalemia)  1  18/92 (19.57%)  15/65 (23.08%)  0/12 (0.00%) 
Sodium, serum-low (hyponatremia)  1  10/92 (10.87%)  18/65 (27.69%)  1/12 (8.33%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  2/92 (2.17%)  4/65 (6.15%)  0/12 (0.00%) 
Uric acid, serum-high (hyperuricemia)  1  9/92 (9.78%)  14/65 (21.54%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - Extrem-lower  1  7/92 (7.61%)  4/65 (6.15%)  0/12 (0.00%) 
Muscle weakness, not d/t neuropathy - Trunk  1  0/92 (0.00%)  0/65 (0.00%)  1/12 (8.33%) 
Muscle weakness, not d/t neuropathy - body/general  1  7/92 (7.61%)  5/65 (7.69%)  1/12 (8.33%) 
Pain - Back  1  6/92 (6.52%)  5/65 (7.69%)  2/12 (16.67%) 
Pain - Bone  1  26/92 (28.26%)  9/65 (13.85%)  1/12 (8.33%) 
Pain - Extremity-limb  1  1/92 (1.09%)  4/65 (6.15%)  0/12 (0.00%) 
Pain - Joint  1  3/92 (3.26%)  6/65 (9.23%)  2/12 (16.67%) 
Pain - Muscle  1  14/92 (15.22%)  12/65 (18.46%)  1/12 (8.33%) 
Nervous system disorders       
Dizziness  1  13/92 (14.13%)  17/65 (26.15%)  3/12 (25.00%) 
Neuropathy: sensory  1  14/92 (15.22%)  8/65 (12.31%)  5/12 (41.67%) 
Ocular/Visual-Other  1  2/92 (2.17%)  2/65 (3.08%)  1/12 (8.33%) 
Pain - Head/headache  1  11/92 (11.96%)  14/65 (21.54%)  1/12 (8.33%) 
Taste alteration (dysgeusia)  1  2/92 (2.17%)  15/65 (23.08%)  0/12 (0.00%) 
Psychiatric disorders       
Confusion  1  2/92 (2.17%)  5/65 (7.69%)  0/12 (0.00%) 
Insomnia  1  9/92 (9.78%)  16/65 (24.62%)  0/12 (0.00%) 
Mood alteration - depression  1  1/92 (1.09%)  4/65 (6.15%)  0/12 (0.00%) 
Renal and urinary disorders       
Hemorrhage, GU - Urinary NOS  1  3/92 (3.26%)  1/65 (1.54%)  1/12 (8.33%) 
Proteinuria  1  1/92 (1.09%)  6/65 (9.23%)  0/12 (0.00%) 
Renal failure  1  9/92 (9.78%)  9/65 (13.85%)  0/12 (0.00%) 
Urinary frequency/urgency  1  3/92 (3.26%)  9/65 (13.85%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  5/92 (5.43%)  5/65 (7.69%)  0/12 (0.00%) 
Cough  1  9/92 (9.78%)  15/65 (23.08%)  1/12 (8.33%) 
Dyspnea (shortness of breath)  1  20/92 (21.74%)  17/65 (26.15%)  3/12 (25.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  0/92 (0.00%)  5/65 (7.69%)  0/12 (0.00%) 
Hiccoughs (hiccups, singultus)  1  0/92 (0.00%)  6/65 (9.23%)  0/12 (0.00%) 
Hypoxia  1  3/92 (3.26%)  6/65 (9.23%)  0/12 (0.00%) 
Pain - Throat/pharynx/larynx  1  4/92 (4.35%)  4/65 (6.15%)  0/12 (0.00%) 
Pleural effusion (non-malignant)  1  5/92 (5.43%)  8/65 (12.31%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatology/Skin-Other  1  2/92 (2.17%)  2/65 (3.08%)  1/12 (8.33%) 
Dry skin  1  1/92 (1.09%)  6/65 (9.23%)  0/12 (0.00%) 
Hair loss/Alopecia (scalp or body)  1  3/92 (3.26%)  31/65 (47.69%)  0/12 (0.00%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Pruritus/itching  1  0/92 (0.00%)  6/65 (9.23%)  0/12 (0.00%) 
Rash/desquamation  1  8/92 (8.70%)  19/65 (29.23%)  2/12 (16.67%) 
Sweating (diaphoresis)  1  2/92 (2.17%)  3/65 (4.62%)  1/12 (8.33%) 
Urticaria (hives, welts, wheals)  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Vascular disorders       
Flushing  1  2/92 (2.17%)  4/65 (6.15%)  0/12 (0.00%) 
Hematoma  1  0/92 (0.00%)  4/65 (6.15%)  0/12 (0.00%) 
Hemorrhage/Bleeding-Other  1  10/92 (10.87%)  5/65 (7.69%)  0/12 (0.00%) 
Hypertension  1  4/92 (4.35%)  7/65 (10.77%)  0/12 (0.00%) 
Hypotension  1  15/92 (16.30%)  21/65 (32.31%)  0/12 (0.00%) 
Thrombosis/thrombus/embolism  1  4/92 (4.35%)  0/65 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00064337     History of Changes
Other Study ID Numbers: S0115
S0115 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: October 26, 2016
Results First Posted: November 6, 2017
Last Update Posted: August 9, 2018