Little Rock, Arkansas 72205


Purpose:

In other past studies at the University of Arkansas for Medical Sciences (UAMS), it was also shown that a combination of drugs called "VTD" (Velcade, thalidomide, and dexamethasone) is a very effective treatment for relapsed myeloma. Researchers want to find out if adding VTD to the transplant regimen will result in better outcomes. Because researchers do not know if adding VTD will be of benefit, this is a research study.


Study summary:

This study has the following goals: - To find out if adding three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) will result in better myeloma response and longer survival of myeloma subjects compared to treatment with high-dose chemotherapy not containing these drugs. - To find out what the side effects will be with both transplant regimens.


Criteria:

Inclusion Criteria: - Patients with symptomatic multiple myeloma, sensitive or refractory to at least one prior line of chemotherapy. - 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 biopsies and laboratory studies are to be completed within 35 days of registration, within 60 days for scans and radiological studies; patients must not have a history of severe 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 MUGA 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. - No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval or if the malignancy is considered much less life threatening than the myeloma. - Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. - Patients must be able to receive full doses of D PACE, in the opinion of the treating investigator, with the exception that patients with creatinine clearance 30-50 ml/min will receive only 50% of the cisplatin dose. Exclusion Criteria: - Fever or active infection requiring intravenous antibiotic, defined as fever or antibiotics within 72 hours from baseline. - Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of < 30ml/min. - Significant neurotoxicity, defined as grade > 3 neurotoxicity per NCI Common Toxicity Criteria (See Appendix). - 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. - Prior adriamycin exposure >450 mg/m2 - Prior exposure to thalidomide which resulted in severe toxicity requiring drug discontinuation.


NCT ID:

NCT00574080


Primary Contact:

Principal Investigator
Frits van Rhee, MD, PhD
University of Arkansas

Nathan Petty
Phone: 501-526-6990
Email: pettynathanm@uams.edu


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72205
United States

Nathan Petty
Phone: 501-526-6990
Email: pettynathanm@uams.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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