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Home > "T" Clinical Trials Conditions > Total Therapy II  Total Therapy II
Total Therapy II
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): University of Arkansas , Celgene Corporation
Synopsis: This study has been designed to evaluate whether “anti-angiogenesis” therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
Details: Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have newly diagnosed active multiple myeloma requiring treatment - Protein criteria must be present in order to evaluate response - Patients must have received no more than one cycle of prior chemotherapy including one month of Dexamethasone and Thalidomide for this disease - Patients must have a performance status of 0-2 based on SWOG criteria - Patients with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months - Patients must be 75 years of age or less at the time of registration Exclusion Criteria: - Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection - Patients must not have uncontrolled diabetes - Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias - Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease - 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 - Pregnant or nursing women may not participate
Total Enrollment: 673
Location and Contact Information:
Overall Study Official:
BartBarlogie, Principal Investigator, UAMS
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: UARK 98-026;
Study Start Date: August 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083551
Other Multiple Myeloma Studies:
1. Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
2. Chemotherapy Related Anemia
3. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
4. Xcellerated T CellsTM in Patients with Multiple Myeloma
5. Blood and Marrow Transplant Clinical Research Network
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
Total Therapy II
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