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Home > "U" Clinical Trials Conditions > UARK 2003-33, Total Therapy III  UARK 2003-33, Total Therapy III
UARK 2003-33, Total Therapy III
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): University of Arkansas , Millennium Pharmaceuticals,Celgene Corporation
Synopsis: There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had better outcomes (meaning patients have lived longer and had better responses to treatment) when compared to patients treated with standard chemotherapy. With this new study, Total Therapy III, researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more, especially for patients with chromosome abnormalities.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Induction Inclusion Criteria: - Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy. - Protein criteria must be present (quantifiable M-component of IgG, IgA, IgD, or IgE and/or urinary kappa or lambda light chain or Bence Jones protein) in order to evaluate response. Non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas on MRI or diffuse hyperintense signal on STIR images in the absence of hematopoietic growth factors. - Patients must have received no more than one cycle of prior chemotherapy for this disease. Patients may have received prior radiotherapy provided approval has been obtained by the Principal Investigator. - Patients must be <75 years of age at the time of initial registration. - Ejection fraction by ECHO or MUGA within the institutional normal range performed within 60 days prior to registration. - Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted, within 60 days of registration. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, there must be a pulmonary consult documenting that the patient is a candidate for high dose therapy. - Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. - All patients must be informed of the investigational nature of this study and must have signed an IRB-approved informed consent in accordance with institutional and federal guidelines. Induction Exclusion Criteria: - Platelet count < 30 x 109/L - ANC < 1.0 x 109/L - Grade > 2 peripheral neuropathy - Hypersensitivity to bortezomib, boron, or mannitol - Uncontrolled diabetes. - Recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. - Evidence of chronic obstructive or chronic restrictive pulmonary disease. - Prior malignancy, 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. - Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. - Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Total Enrollment: 300
Location and Contact Information:
University of Arkansas for Medical Sciences/MIRT *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Julie Stover 501-296-1503
Additional Information:
Study ID Numbers: UARK 2003-33;
Study Start Date: January 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081939
Other Multiple Myeloma Studies:
1. Pegfilgrastim (Neulasta) for stem cell mobilization
2. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
3. Epoetin alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
4. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
5. CDC-501 therapy in relapsed or refractory multiple myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
UARK 2003-33, Total Therapy III
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