UARK 98-026, Total Therapy II - A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the beneficial role of anti-angiogenesis therapy with thalidomide and to determine the role of dose consolidation during consolidation therapy following tandem autotransplants with melphalan 200 mg/m2.
Overall event free survival time
Bart Barlogie, M.D., Ph.D.
United States: Food and Drug Administration
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