UARK 98-035, A Phase III Study of D.T. PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma
All patients will receive two cycles, 4-6 weeks apart, of a combination of chemotherapy
drugs (a regimen called D.T. PACE) and collection of peripheral blood stem cells. D.T. PACE
consists of 6 chemotherapy drugs (Dexamethasone, Thalidomide, CisPlatin, Adriamycin,
Cyclophoshamide, and Etoposide). Four to six weeks after the last cycle of D.T. PACE, each
patient with no evidence of myeloma progression will be randomly assigned to receive 1)
Autologous Transplant as described below or 2) Additional cycles of D.T. PACE. Since it is
not known at this time which treatment is the best, patients will be placed by chance in one
of the two groups. If tests show that myeloma is in remission at the time of randomization,
2 additional cycles of D.T. PACE will be given. If myeloma is not in remission, 2
additional cycles of D.T. PACE will be given, then the myeloma will be re-assessed. If the
patients myeloma protein has decreased by 90% since baseline or better, 2 more cycles are
given. If it has not decreased that much or has gotten worse, the patient will be offered
autologous transplantation. Patients with no financial coverage for transplant, or those
that have inadequate stem cell collections to support two transplants, will not be
randomized and will proceed directly to treatment 2, continued D.T. PACE. If it is
determined that the myeloma did not respond adequately to the first 2 cycles of D.T. PACE,
then the patient will not be randomized and will proceed directly to autologous transplant.
Between 2 and 4 months after the first PBSC transplant, the patient will undergo a second
course of high-dose Melphalan and PBSC transplant. In order for all patients to receive the
maximum possible benefit, patients may "cross-over" to the other treatment arm if the
myeloma does not go into complete remission or at any time myeloma progresses after
When the physician feels that the maximum benefit from chemotherapy has been received (best
partial or complete remission) the last phase of the study will start, which is maintenance.
Patients will be randomly assigned to receive either low dose (50 mg) or higher dose (200
mg) thalidomide with the dexamethasone.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
1.1 To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients whether angio-chemotherapy with D.T. PACE may be equivalent or superior to tandem transplant.
Barthel Barlogie, M.D., Ph.D.
United States: Food and Drug Administration
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