Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083876
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2004-06-02
Brief Title:
DT PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 98-035 A Phase III Study of DT PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study has been designed to evaluate whether combination chemotherapy and anti-angiogenesis therapy with thalidomide is equal or superior to autologous transplantation for the treatment of multiple myeloma
Detailed Description:
All patients will receive two cycles 4-6 weeks apart of a combination of chemotherapy drugs a regimen called DT PACE and collection of peripheral blood stem cells DT PACE consists of 6 chemotherapy drugs Dexamethasone Thalidomide CisPlatin Adriamycin Cyclophoshamide and Etoposide Four to six weeks after the last cycle of DT 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 DT 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 DT PACE will be given If myeloma is not in remission 2 additional cycles of DT 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 DT PACE If it is determined that the myeloma did not respond adequately to the first 2 cycles of DT 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 randomization
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
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 randomization
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None