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Trial record 67 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of 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: NCT00006184
Recruitment Status : Completed
First Posted : August 24, 2000
Results First Posted : January 24, 2013
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ronald Gress, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Myeloma Immunoglobulin Idiotype Vaccine
Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Cyclosporine
Drug: Doxorubicin hydrochloride
Drug: Etoposide
Drug: Fludarabine phosphate
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Methotrexate
Biological: GMCSF (granulocyte macrophage colony stimulating factor)
Biological: GCSF (granulocyte colony stimulating factor)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Hide Arm/Group Description Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
Period Title: Overall Study
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Death             1             0
Arm/Group Title Recipient - Chemotherapy Group Donor - Vaccination Generation Group Total
Hide Arm/Group Description Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
53.2  (4.59) 50.8  (6.05) 52.  (5.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
6
  60.0%
9
  45.0%
Male
7
  70.0%
4
  40.0%
11
  55.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
  10.0%
1
  10.0%
2
  10.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
  80.0%
8
  80.0%
16
  80.0%
Hispanic
1
  10.0%
1
  10.0%
2
  10.0%
Non Hispanic
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
1.Primary Outcome
Title Immune Response
Hide Description Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.
Time Frame 105 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was only pre-specified to be measured in the recipient Arm/Group.
Arm/Group Title Recipient - Chemotherapy Group
Hide Arm/Group Description:
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Particpants
7
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Time Frame 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Hide Arm/Group Description:
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
Time Frame 9 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Hide Arm/Group Description Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization. 3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
All-Cause Mortality
Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      0/10 (0.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1 [1]  1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain or cramping  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Diarrhea (without colostomy)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Nausea and vomiting  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infections and infestations     
Infection without neutropenia  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Investigations     
Leukocytes (total WBC)  1  6/10 (60.00%)  13 0/10 (0.00%)  0
Leukocytes (total WBC) for BMT  1  4/10 (40.00%)  4 0/10 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  7/10 (70.00%)  16 0/10 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC) for BMT  1  8/10 (80.00%)  10 0/10 (0.00%)  0
Platelets  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Platelets for BMT  1  2/10 (20.00%)  2 0/10 (0.00%)  0
SGOT (AST)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
SGPT (ALT)  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Transfusion: Platelets  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  3/10 (30.00%)  3 0/10 (0.00%)  0
Hyperglycemia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Metabolic-Other (GGT)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Nervous system disorders     
Neurologic-Other (Neuropathy)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Mood alteration::Depression  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  2/10 (20.00%)  2 0/10 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Recipient - Chemotherapy Group Donor - Vaccination Generation Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia  1  3/10 (30.00%)  3 0/10 (0.00%)  0
Lymphatics  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Lymphatics-Other (Adenopathy)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Hematologic-Other (Splenomegaly in donor-resolved)  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Febrile neutropenia  1 [1]  3/10 (30.00%)  4 0/10 (0.00%)  0
Cardiac disorders     
Pericardial effusion/pericarditis  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Eye disorders     
Cataract  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Ocular-Other (Ocular cGVHD)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain or cramping  1  2/10 (20.00%)  3 3/10 (30.00%)  3
Constipation  1  3/10 (30.00%)  5 1/10 (10.00%)  2
Diarrhea  1  1/10 (10.00%)  6 0/10 (0.00%)  0
Diarrhea (with colostomy)  1  1/10 (10.00%)  2 0/10 (0.00%)  0
Diarrhea (without colostomy)  1  7/10 (70.00%)  14 0/10 (0.00%)  0
Diarrhea (without colostomy) BMT  1  1/10 (10.00%)  4 0/10 (0.00%)  0
Ileus (or neuroconstipation)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Nausea  1  9/10 (90.00%)  25 0/10 (0.00%)  0
Rectal bleeding/hematochezia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Salivary gland changes  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Taste disturbance (dysgeusia)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Vomiting  1  8/10 (80.00%)  11 0/10 (0.00%)  0
Diarrhea for BMT  1  3/10 (30.00%)  4 0/10 (0.00%)  0
General disorders     
Constitutional Symptoms-Other (CGVHD-skin)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Edema  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  6/10 (60.00%)  10 4/10 (40.00%)  5
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  8/10 (80.00%)  22 1/10 (10.00%)  3
Injection site reaction  1  8/10 (80.00%)  25 10/10 (100.00%)  29
Injection site reaction, bilat arms  1  1/10 (10.00%)  2 0/10 (0.00%)  0
Injection site reaction, bilat legs  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pain - Other  1 [2]  4/10 (40.00%)  8 2/10 (20.00%)  3
Rigors/chills  1  2/10 (20.00%)  2 2/10 (20.00%)  4
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  4/10 (40.00%)  5 0/10 (0.00%)  0
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  2/10 (20.00%)  4 1/10 (10.00%)  1
Allergy - Other (Transfusion reaction (platelets)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infections and infestations     
Catheter-related infection  1  4/10 (40.00%)  5 0/10 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia  1  6/10 (60.00%)  9 0/10 (0.00%)  0
Infection w/out neutropenia, catheter related  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infection without neutropenia  1  6/10 (60.00%)  15 0/10 (0.00%)  0
Infection without neutropenia, blood  1  1/10 (10.00%)  2 0/10 (0.00%)  0
Infection without neutropenia, C-diff  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infection without neutropenia, Nasal Pharynx  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infection without neutropenia, wound  1  1/10 (10.00%)  3 0/10 (0.00%)  0
Infection, Other (Upper respiratory infection (URI))  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Infection: blood  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Investigations     
Alkaline phosphatase  1  3/10 (30.00%)  6 2/10 (20.00%)  2
Amylase  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Bilirubin  1  4/10 (40.00%)  11 0/10 (0.00%)  0
Bilirubin - graft versus host disease (GVHD)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Creatinine  1  7/10 (70.00%)  12 0/10 (0.00%)  0
Hemoglobin (hgb)  1  10/10 (100.00%)  41 0/10 (0.00%)  0
Leukocytes (total WBC)  1  8/10 (80.00%)  34 0/10 (0.00%)  0
Leukocytes (total WBC) for BMT  1  4/10 (40.00%)  9 0/10 (0.00%)  0
Lymphopenia  1  7/10 (70.00%)  29 1/10 (10.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  7/10 (70.00%)  19 0/10 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC) for BMT  1  4/10 (40.00%)  9 0/10 (0.00%)  0
Platelets  1  7/10 (70.00%)  22 3/10 (30.00%)  4
Platelets for BMT  1  6/10 (60.00%)  11 0/10 (0.00%)  0
SGOT (AST)  1  8/10 (80.00%)  42 2/10 (20.00%)  2
SGPT (ALT)  1  8/10 (80.00%)  32 3/10 (30.00%)  3
Transfusion: Platelets for BMT  1  6/10 (60.00%)  6 0/10 (0.00%)  0
Transfusion: pRBCs  1  3/10 (30.00%)  4 0/10 (0.00%)  0
Transfusion: pRBCs for BMT  1  6/10 (60.00%)  6 0/10 (0.00%)  0
Weight loss  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Anorexia  1  1/10 (10.00%)  2 0/10 (0.00%)  0
Hyperglycemia  1  3/10 (30.00%)  3 0/10 (0.00%)  0
Hypermagnesemia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Hypoalbuminemia  1  4/10 (40.00%)  6 1/10 (10.00%)  2
Hypocalcemia  1  4/10 (40.00%)  6 1/10 (10.00%)  1
Hypokalemia  1  2/10 (20.00%)  2 2/10 (20.00%)  3
Hypomagnesemia  1  6/10 (60.00%)  6 2/10 (20.00%)  2
Hyponatremia  1  6/10 (60.00%)  14 0/10 (0.00%)  0
Hypophosphatemia  1  3/10 (30.00%)  5 1/10 (10.00%)  1
Metabolic-Other (Hyperbilirubinemia; hyperbilirubinemia r/t GVH)  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Hypercalcemia  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Bone pain  1  6/10 (60.00%)  17 3/10 (30.00%)  6
Chest pain (non-cardiac and non-pleuritic)  1  2/10 (20.00%)  2 3/10 (30.00%)  3
Joint, muscle, or bone (osseous)- Other (Calf cramping)  1  1/10 (10.00%)  1 1/10 (10.00%)  1
Myalgia (muscle ache)  1  1/10 (10.00%)  1 3/10 (30.00%)  7
Arthralgia (joint pain)  1  0/10 (0.00%)  0 2/10 (20.00%)  4
Nervous system disorders     
Dizziness/lightheadedness  1  1/10 (10.00%)  1 2/10 (20.00%)  3
Headache  1  1/10 (10.00%)  1 3/10 (30.00%)  4
Neuropathic pain  1 [3]  1/10 (10.00%)  1 0/10 (0.00%)  0
Neuropathy-sensory  1  5/10 (50.00%)  5 0/10 (0.00%)  0
Vasovagal episode  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Insomnia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Mood alteration-depression  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Mood alteration-euphoria  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pleural effusion (non-malignant)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Urinary frequency/urgency  1  2/10 (20.00%)  4 0/10 (0.00%)  0
Reproductive system and breast disorders     
Dyspareunia  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/10 (50.00%)  5 0/10 (0.00%)  0
Dyspnea (shortness of breath)  1  4/10 (40.00%)  5 1/10 (10.00%)  1
Hemoptysis  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Hypoxia  1  5/10 (50.00%)  9 0/10 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pulmonary-Other (URI)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis  1  1/10 (10.00%)  2 1/10 (10.00%)  3
Pigmentation changes (e.g., vitiligo)  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Pruritus  1  1/10 (10.00%)  2 3/10 (30.00%)  3
Rash/desquamation  1  6/10 (60.00%)  11 2/10 (20.00%)  2
Rash/desquamation for BMT  1  2/10 (20.00%)  2 1/10 (10.00%)  1
Skin-Other (Drug reaction face, hands, neck)  1  1/10 (10.00%)  2 1/10 (10.00%)  1
Sweating (diaphoresis)  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Dry skin  1  0/10 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Flushing  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Hypertension  1  2/10 (20.00%)  2 0/10 (0.00%)  0
Hypotension  1  3/10 (30.00%)  3 1/10 (10.00%)  1
Thrombosis/embolism  1  1/10 (10.00%)  1 0/10 (0.00%)  0
Hot flashes/flushes  1  0/10 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection)
[2]
catheter site; hp and leg; hip and leg exacerbation related GCSF; meniscus tear
[3]
(e.g., jaw pain, neurologic pain, phantom limb pain, post infection-infectious neuralgia, or painful neuropathies
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr, Claude Sportes, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-435-5280
Responsible Party: Ronald Gress, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006184     History of Changes
Obsolete Identifiers: NCT00020306
Other Study ID Numbers: 000201
00-C-0201
First Submitted: August 23, 2000
First Posted: August 24, 2000
Results First Submitted: December 13, 2012
Results First Posted: January 24, 2013
Last Update Posted: October 20, 2017