GoldBamboo.com - Knowledge is strong medicine
  

UARK 2003-41: A Study of High-Dose Density Therapy in Patients with Multiple Myeloma - Article


  Not Signed In - Sign In / Register


Get Your Free Credit Report Right Now!

Zip Code:






Metered Dose Inhaler

 




Clinical Trial: UARK 2003-41: A Study of High-Dose Density Therapy in Patients with Multiple Myeloma

This study is currently recruiting patients.

Sponsored by: University of Arkansas
Information provided by: University of Arkansas

Purpose

The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.
Condition Intervention Phase
Multiple Myeloma
 Procedure: High-Dose Density Therapy
Phase II

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: UARK 2003-41: A Phase II Study of High-Dose Density Therapy with Tandem Autologous Transplants for Patients with Multiple Myeloma

Further Study Details: 
Primary Outcomes: To evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.
Secondary Outcomes: To evaluate the ability of pegfilgrastim to mobilize stem cells when administered following DTPACE in MM patients with active disease, compared to historical controls mobilized with DTPACE and either GM-CSF or G-CSF.
Expected Total Enrollment:  140

Study start: December 2003;  Expected completion: December 2013
Last follow-up: December 2012;  Data entry closure: December 2012

This study will evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients with symptomatic multiple myeloma, previously treated or untreated.
  • Patients previously untreated must not be eligible for UARK 2003-33.
  • Karnofsky performance score > 60%, unless due to MM
  • Patients must be <75 years of age at the time of registration
  • Patient must not have had a prior auto- or allotransplant
  • Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
  • Negative serology for HIV.
  • Baseline studies within 60 days prior to registration; patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
  • Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. Ejection fraction by ECHO or must be > 40% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated.

Exclusion Criteria:

  • Uncontrolled infection as defined in protocol section 5.1.11
  • Liver function abnormalities with total bilirubin more than twice the upper limit of normal or AST or ALT more than three times the upper limit of normal
  • Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of < 30ml/min
  • Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria
  • Platelet count < 100,000/mm3, or ANC < 1,000/μl
  • POEMS Syndrome
  • Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis
  • New York Hospital Association (NYHA) Class III or Class IV heart failure
  • Myocardial infarction within the last 6 months
  • Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias
  • Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
  • Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy [β-HCG] test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each dose of study drug
  • Breast-feeding women may not participate
  • Prior adriamycin exposure >450 mg/m2

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00113932


Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Cherie Harless  501-296-1503  Ext. 1463    harlesscheriel@uams.edu 
Michael Burns  501-296-1503  Ext. 1420    burnsmichaelj@uams.edu 
Guido Tricot, M.D., Ph.D.,  Principal Investigator
Frits Van Rhee, MD, PhD,  Sub-Investigator
Bart Barlogie, MD, PhD,  Sub-Investigator
Nidhi Jain, MD,  Sub-Investigator
Elias Kiwan, MD,  Sub-Investigator
Elias Anaissie, MD,  Sub-Investigator
Mauricio Pineda-Roman, MD,  Sub-Investigator
Somashekar Krishna, MD,  Sub-Investigator
Maurizio Zangari, MD,  Sub-Investigator
Klaus Hollmig, MD,  Sub-Investigator
Michele Fox, MD,  Sub-Investigator
Abid Mohiuddin, MD,  Sub-Investigator

Study chairs or principal investigators

Guido Tricot, MD, PhD,  Principal Investigator,  UAMS   

More Information

Study ID Numbers:  UARK 2003-41
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 10, 2005
ClinicalTrials.gov Identifier:  NCT00113932
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $30 a year, a savings of 70% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Metered Dose Inhaler.

November 27, 2009



Page Updated: October 3, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Health Forums

Copyright © 2004-2009 - Anaconda Partners LLC - All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.