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.
|
Purpose
| 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
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
Eligibility
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
Arkansas
University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
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
Guido Tricot, MD, PhD, Principal Investigator, UAMS
More Information
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
- A MDI and Inspirease Spacer (Cleveland Clinic)
- Metered Dose Inhaler (Cleveland Clinic)

Not Signed In -

