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Trial record 57 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment

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ClinicalTrials.gov Identifier: NCT01548573
Recruitment Status : Terminated (Met study stopping rules)
First Posted : March 8, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guido Tricot, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Dexamethasone
Procedure: Tandem autologous stem cell transplant
Drug: Cisplatin
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Bortezomib
Drug: Thalidomide
Drug: Melphalan
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
Period Title: Overall Study
Started 19
Completed 14
Not Completed 5
Reason Not Completed
Death             3
Withdrawal by Subject             2
Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  84.2%
>=65 years
3
  15.8%
[1]
Measure Analysis Population Description: Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
59.4
(49 to 70.6)
[1]
Measure Analysis Population Description: Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
8
  42.1%
Male
11
  57.9%
[1]
Measure Analysis Population Description: Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
[1]
Measure Analysis Population Description: Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
1.Primary Outcome
Title Event-Free Survival (EFS)
Hide Description To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description

Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).

Data for outcome measure 1 were not collected.

Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description:

Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.

Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.

Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.

Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.

Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.

DP

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Identification of Drug Resistant Genes
Hide Description To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description

Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).

Data for outcome measure 2 were not collected.

Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description:
This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.
Hide Description To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description

Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).

Data for outcome measure 3 were not collected.

Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description:
This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description

Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).

Data for outcome measure 4 were not collected.

Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description:
This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tandem Transplant in MM <12 Mos of Prior Treatment
Hide Arm/Group Description This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
All-Cause Mortality
Tandem Transplant in MM <12 Mos of Prior Treatment
Affected / at Risk (%)
Total   3/19 (15.79%)    
Show Serious Adverse Events Hide Serious Adverse Events
Tandem Transplant in MM <12 Mos of Prior Treatment
Affected / at Risk (%) # Events
Total   13/19 (68.42%)    
Blood and lymphatic system disorders   
Nausea, failure-to-thrive, and line-associated deep vein thrombosis   1/19 (5.26%)  1
Cardiac disorders   
Chest pain, air embolism   1/19 (5.26%)  1
Myocardial infarction   1/19 (5.26%)  1
Atrial Fibrillation with RVR   2/19 (10.53%)  2
Pneumonia, Atrial fib w/ cardioversion   1/19 (5.26%)  1
Gastrointestinal disorders   
Cholecystitis   1/19 (5.26%)  1
Nausea, and abdominal pain   1/19 (5.26%)  1
General disorders   
Fever   2/19 (10.53%)  2
Neutropenic fever   2/19 (10.53%)  2
Fever   3/19 (15.79%)  3
Malaise and abrupt chest pain   1/19 (5.26%)  1
Neutropenic fever, abdominal pain, and loose stools   1/19 (5.26%)  1
Hypoxia, fever, pulmonary infiltrates with nodules, and C Diff + diarrhea   1/19 (5.26%)  1
Chills, cough, throat pain, dyspnea. Mucositis. + hMPV. Engraftment syndrome   1/19 (5.26%)  1
Infections and infestations   
Sepsis   1/19 (5.26%)  1
Viral pneumonia   1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Bone pain   1/19 (5.26%)  1
Severe back pain   1/19 (5.26%)  1
Nervous system disorders   
Stoke secondary to cardio-embolism   1/19 (5.26%)  1
Renal and urinary disorders   
Acute kidney injury, uncontrolled hypertension, thrombotic microangiopathy   1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia   1/19 (5.26%)  1
Respiratory distress, fevers, and pneumonia   1/19 (5.26%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tandem Transplant in MM <12 Mos of Prior Treatment
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Anemia   19/19 (100.00%)  65
Anemia (Hemolytic)   1/19 (5.26%)  1
Bone marrow hypocellularity   1/19 (5.26%)  2
Engraftment fevers   1/19 (5.26%)  1
Febrile Neutropenia   10/19 (52.63%)  10
Other: Platelet refractoriness   1/19 (5.26%)  1
Cardiac disorders   
Atrial fibrillation   2/19 (10.53%)  3
Atrial Fibrillation with RVR   1/19 (5.26%)  1
Atrial flutter   1/19 (5.26%)  1
Bradycardia   1/19 (5.26%)  1
chest pain-cardiac   1/19 (5.26%)  1
Left ventricular systolic dysfunction   1/19 (5.26%)  1
myocardial infarction   1/19 (5.26%)  1
Palpitations   1/19 (5.26%)  1
Sinus bradycardia   1/19 (5.26%)  1
Ear and labyrinth disorders   
Ear Pain   1/19 (5.26%)  1
Tinnitus   1/19 (5.26%)  1
Eye disorders   
Blurred vision   2/19 (10.53%)  2
Gastrointestinal disorders   
Abdominal Pain   1/19 (5.26%)  1
Abdominal Pain/discomfort LLQ   1/19 (5.26%)  1
Abdominal Pain/discomfort RUQ   1/19 (5.26%)  1
Bleeding from hemorrhoids   1/19 (5.26%)  1
Bloating   3/19 (15.79%)  3
C-Diff colitis   1/19 (5.26%)  1
Colitis   1/19 (5.26%)  1
Colitis (C-Diff)   1/19 (5.26%)  1
Constipation   7/19 (36.84%)  14
Diarrhea   10/19 (52.63%)  11
Diarrhea (c diff pos)   3/19 (15.79%)  4
Diarrhea (C Diff Neg)   8/19 (42.11%)  8
Diarrhea (C Diff)   2/19 (10.53%)  3
Diarrhea/loose stools   1/19 (5.26%)  1
Dry mouth   2/19 (10.53%)  2
Dysphagia   2/19 (10.53%)  2
Dyspnea   8/19 (42.11%)  12
Enterocolitis   1/19 (5.26%)  1
Esophagitis   1/19 (5.26%)  1
Esophagitis (CMV related)   1/19 (5.26%)  1
Gastritis   1/19 (5.26%)  2
Gastroenteritis   1/19 (5.26%)  1
Gastro-esophageal reflux   2/19 (10.53%)  3
GERD with Barrett's esophagus   1/19 (5.26%)  1
Mucositis   1/19 (5.26%)  1
Mucositis (morphine prn)   1/19 (5.26%)  1
Mucositis (oral)   1/19 (5.26%)  1
Mucositis (oral) requiring TPN   1/19 (5.26%)  1
Mucositis oral   4/19 (21.05%)  7
Mucositis oral (cvn + pca narcotics)   1/19 (5.26%)  1
Nausea   11/19 (57.89%)  24
Nausea with dexamethasone   1/19 (5.26%)  1
Nausea/vomiting (from post-nasal drip)   1/19 (5.26%)  1
Nausea/Vomiting (TPN)   1/19 (5.26%)  1
Oral pain (tongue lesion)   1/19 (5.26%)  1
Stomach pain   1/19 (5.26%)  1
Stomach pain (not during dex admin)   1/19 (5.26%)  1
Vomiting   5/19 (26.32%)  9
General disorders   
Ankle edema   1/19 (5.26%)  1
Bilateral edema in limbs   1/19 (5.26%)  1
Bleeding at port site   1/19 (5.26%)  1
Dizziness   8/19 (42.11%)  10
Dizziness (orthostatic hypotension)   1/19 (5.26%)  1
Edema   1/19 (5.26%)  1
Edema (feet)   1/19 (5.26%)  1
Edema in left lower ankle   1/19 (5.26%)  1
Edema Limbs   1/19 (5.26%)  1
Edema limbs (bilateral)   1/19 (5.26%)  1
Edema limbs (legs)   1/19 (5.26%)  1
Engraftment fever   1/19 (5.26%)  1
Engraftment fevers controlled with steroids   1/19 (5.26%)  1
Fatigue   13/19 (68.42%)  26
Fever   1/19 (5.26%)  1
Fever (non-neutropenic)   5/19 (26.32%)  6
Gait Disturbance   1/19 (5.26%)  1
Gait disturbance (d/t dizziness)   1/19 (5.26%)  1
Infusion Site Extravasation w bruising, no pain   1/19 (5.26%)  1
Localized edema (leg)   1/19 (5.26%)  1
Localized edema (right leg) w/out DVT   1/19 (5.26%)  1
Malaise   1/19 (5.26%)  1
Multi-organ failure   1/19 (5.26%)  1
Neutropenic fever   1/19 (5.26%)  1
Non-cardiac chest pain   2/19 (10.53%)  2
Non-cardiac pleuritic chest pain   1/19 (5.26%)  1
Other: Failure to thrive   2/19 (10.53%)  2
Pain at port and catheter site   1/19 (5.26%)  1
Swelling of right hand (neg doppler)   1/19 (5.26%)  1
Weakness   2/19 (10.53%)  4
Hepatobiliary disorders   
Cholecystitis (w/ gallstone present)   1/19 (5.26%)  1
Gallbladder sludge   1/19 (5.26%)  1
Immune system disorders   
Cytokine release syndrome   1/19 (5.26%)  1
Engraftment syndrome   2/19 (10.53%)  2
Infections and infestations   
Catheter related infection   1/19 (5.26%)  1
Catheter related infection: enterococcal (vanc sensitive)   2/19 (10.53%)  2
Catheter-related infection   1/19 (5.26%)  1
catheter-related infection (gram+ cocci)   1/19 (5.26%)  1
Catheter-related infection (VRE)   1/19 (5.26%)  1
Catheter-related infection: enterococcal (vanc sensitive)   1/19 (5.26%)  1
CMV Reactivation   1/19 (5.26%)  1
Coag neg staph bacteremia x 3   1/19 (5.26%)  1
HHV 6 viremia reactivation   1/19 (5.26%)  1
Laryngitis   1/19 (5.26%)  1
Lip infection (HSV)   1/19 (5.26%)  1
Lung infection: fungal pneumonia   1/19 (5.26%)  1
Lung infection: left lower lobe consolidation   1/19 (5.26%)  1
Lung infection: pneumonia   2/19 (10.53%)  2
Lung infection: pneumonia (hMPV and staph)   1/19 (5.26%)  1
Lung infection: Pulmonary infiltrates with nodules   1/19 (5.26%)  1
Lung infection: RSV Pneumonia   1/19 (5.26%)  1
Lung Infection: serratia marcescens   1/19 (5.26%)  1
Lung infection: viral pneumonia   1/19 (5.26%)  1
Lung infections: CMV pneumonia   1/19 (5.26%)  1
Lymphopenic fever   1/19 (5.26%)  1
Other: CMV reactivation   1/19 (5.26%)  1
Other: VRE + coag neg staph bacteremia (Enterococcus faecium)   1/19 (5.26%)  1
Otitis media   1/19 (5.26%)  1
Pansinusitis   1/19 (5.26%)  1
Pharyngitis   1/19 (5.26%)  1
Sepsis   1/19 (5.26%)  1
Sepsis (Gram Neg)   1/19 (5.26%)  1
Toe infection   1/19 (5.26%)  1
Vancomycin-Resistant Enterococcus   2/19 (10.53%)  2
Injury, poisoning and procedural complications   
Bruising on abdomen and arms   1/19 (5.26%)  1
Left Rib Fracture   1/19 (5.26%)  1
Vascular Access Complication (air embolism)   1/19 (5.26%)  1
Investigations   
Activated PTT prolonged   1/19 (5.26%)  2
Alanine aminotransferase increased   4/19 (21.05%)  4
Allergic reaction during PBSC Collection   1/19 (5.26%)  1
ALT increased   5/19 (26.32%)  6
AST increased   4/19 (21.05%)  4
Creatinine increased   2/19 (10.53%)  4
Lymphocyte count decreased   19/19 (100.00%)  31
Neutrophil count decreased   1/19 (5.26%)  1
Other: sub-therapeutic INR   1/19 (5.26%)  1
Other: Vanc sensitive Enterococcal + coag neg staph bacteremia   1/19 (5.26%)  1
Platelet count decreased   19/19 (100.00%)  65
PTT prolonged   1/19 (5.26%)  1
Serum amylase increased   1/19 (5.26%)  1
WBC decreased   19/19 (100.00%)  56
Weight Loss   3/19 (15.79%)  4
Metabolism and nutrition disorders   
Anorexia   5/19 (26.32%)  8
Hypercalcemia   1/19 (5.26%)  1
Hyperglycemia   1/19 (5.26%)  14
Hyperglycemia (Dex)   9/19 (47.37%)  15
Hypernatremia   4/19 (21.05%)  4
Hyperuricemia   2/19 (10.53%)  2
Hypoalbuminemia   7/19 (36.84%)  9
Hypocalcemia   18/19 (94.74%)  42
Hypoglycemia   1/19 (5.26%)  2
Hypokalemia   12/19 (63.16%)  22
Hypomagnesemia   1/19 (5.26%)  1
Hypophosphatemia   16/19 (84.21%)  31
Iron overload   1/19 (5.26%)  1
Other: Chloride increased   1/19 (5.26%)  1
Other: CO2 decreased   1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Back Pain   4/19 (21.05%)  5
Bilateral Calf Pain at time of engraftment   1/19 (5.26%)  1
Bone pain   2/19 (10.53%)  2
Bone/joint pain   1/19 (5.26%)  1
Generalized muscle weakness   3/19 (15.79%)  3
Generalized bone pain   1/19 (5.26%)  1
Hip pain   1/19 (5.26%)  1
Hyponatremia   6/19 (31.58%)  7
Joint pain right knee   1/19 (5.26%)  1
joint pains in right hip and shoulder   1/19 (5.26%)  1
Low back and hip pain   1/19 (5.26%)  1
Lower back pain   2/19 (10.53%)  2
Minor left leg pain   1/19 (5.26%)  1
Other, muscle spasms in lower back and neck   1/19 (5.26%)  1
Pain   2/19 (10.53%)  2
Pain in both elbows   1/19 (5.26%)  1
Pain in extremity (left lower arm)   1/19 (5.26%)  1
Pain in hips and left lower leg   1/19 (5.26%)  1
Pain in lower back   1/19 (5.26%)  1
Rib pain   1/19 (5.26%)  1
Rt knee joint pain w/ swelling   1/19 (5.26%)  1
Nervous system disorders   
Akathisia (restless feet)   1/19 (5.26%)  1
Dygeusia (abnormal taste)   1/19 (5.26%)  1
Dysgeusia   1/19 (5.26%)  1
Dysgeusia (altered taste)   1/19 (5.26%)  1
Hand tremor   1/19 (5.26%)  1
Headache   5/19 (26.32%)  7
Headache with dexamethasone   1/19 (5.26%)  1
Left hemiparesis   1/19 (5.26%)  1
Paresthesia   1/19 (5.26%)  1
Peripheral Neuropathy   4/19 (21.05%)  7
Peripheral Neuropathy (feet)   1/19 (5.26%)  2
Peripheral neuropathy (hands)   1/19 (5.26%)  1
Peripheral Neuropathy (thal held)   1/19 (5.26%)  1
Peripheral Neuropathy (thalidomide stopped)   1/19 (5.26%)  1
Peripheral Neuropathy (toes)   1/19 (5.26%)  1
Somnolence   3/19 (15.79%)  3
Stroke   1/19 (5.26%)  1
Syncope   2/19 (10.53%)  2
Tremor   1/19 (5.26%)  1
Tremor in hands, R> L   2/19 (10.53%)  2
Psychiatric disorders   
Anxiety   1/19 (5.26%)  2
Confusion   1/19 (5.26%)  1
Delirium   3/19 (15.79%)  3
Hallucinations (with voriconazole)   1/19 (5.26%)  1
Insomnia   1/19 (5.26%)  1
Insomnia (Dex)   5/19 (26.32%)  5
Renal and urinary disorders   
Acute kidney injury   1/19 (5.26%)  1
Urinary Frequency   1/19 (5.26%)  1
Urinary Frequency (Nocturnal)   1/19 (5.26%)  1
Urinary Incontinence   1/19 (5.26%)  3
Respiratory, thoracic and mediastinal disorders   
Adult Respiratory Distress Syndrome   2/19 (10.53%)  2
aspiration   1/19 (5.26%)  1
Cough   1/19 (5.26%)  1
Dysnea   1/19 (5.26%)  1
Hypoxia   5/19 (26.32%)  5
Laryngeal inflammation   1/19 (5.26%)  1
Nasal congestion   1/19 (5.26%)  1
Pleural Effusion   2/19 (10.53%)  2
Pneumonitis   1/19 (5.26%)  1
Pneumonitis (hMPV)   1/19 (5.26%)  1
Post-nasal drip   1/19 (5.26%)  1
Pulmonary Edema   4/19 (21.05%)  4
Respiratory failure/ARDS   1/19 (5.26%)  1
Sore Throat   2/19 (10.53%)  2
Skin and subcutaneous tissue disorders   
Hyperhidrosis (excessive perspiration)   1/19 (5.26%)  1
Maculopapular rash   1/19 (5.26%)  1
Rash   2/19 (10.53%)  2
Rash - face and neck   1/19 (5.26%)  1
Rash maculo-papular   1/19 (5.26%)  1
Scalp Pain   1/19 (5.26%)  1
Vascular disorders   
Flushing   1/19 (5.26%)  1
Hypertension   3/19 (15.79%)  5
Hypotension   5/19 (26.32%)  5
Hypotension with PBSC infusion   1/19 (5.26%)  1
Orthostatic Hypotension   1/19 (5.26%)  1
Other: Left carotid artery stenosis   1/19 (5.26%)  1
Indicates events were collected by systematic assessment
Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Guido Tricot, MD, PhD
Organization: University of Iowa
Phone: 319-356-3425
Responsible Party: Guido Tricot, University of Iowa
ClinicalTrials.gov Identifier: NCT01548573     History of Changes
Other Study ID Numbers: 201202818
7R01CA115399 ( U.S. NIH Grant/Contract )
First Submitted: February 29, 2012
First Posted: March 8, 2012
Results First Submitted: April 4, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017