Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002878
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A PHASE III STUDY OF PSC-833 IN COMBINATION WITH VINCRISTINE DOXORUBICIN AND DEXAMETHASONE PSC-833VAD VERSUS VAD ALONE IN PATIENTS WITH RELAPSING OR REFRACTORY MULTIPLE MYELOMA
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Some tumors become resistant to chemotherapy drugs Combining PSC 833 with chemotherapy may reduce resistance to the drug and allow more tumor cells to be killed It is not yet known whether combination chemotherapy plus PSC 833 is more effective than combination chemotherapy alone in treating patients with relapsed or refractory multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Compare the overall survival and objective response rate of patients with relapsed or refractory multiple myeloma treated with vincristine doxorubicin and dexamethasone VAD with or without PSC 833
Compare event free survival and subjective response in patients treated with these regimens
Correlate treatment outcome with p-glycoprotein expression
Determine whether prognostic factors previously determined to be useful in untreated patients ie plasma cell labeling index and multidrug resistance determined from bone marrow aspirates serum beta 2-microglobulin and interleukin-6 receptor levels correlate with objective and subjective response and event-free and overall survival in patients treated with these regimens
Compare the toxicity of VAD with or without PSC 833
OUTLINE This is a randomized multicenter study Patients are stratified by response to prior treatment prior doxorubicin andor vincristine prior autologous peripheral blood stem cell transplantation and center
Patients are randomized to 1 of 2 treatment arms
Arm I The first group receives vincristine doxorubicin and dexamethasone VAD Patients receive higher dose vincristine IV over 96 hours and higher dose doxorubicin IV over 96 hours on days 1-4 and oral dexamethasone daily on days 1-4 and 15-18
Arm II The second group receives VAD plus oral PSC 833 Patients receive oral PSC 833 every 6 hours beginning on day 1 and continuing for 20 doses Patients receive lower dose vincristine IV over 96 hours and lower dose doxorubicin IV over 96 hours on days 2-5 and oral dexamethasone daily on days 2-5 and 16-19
Treatment in both arms repeats every 4 weeks in the absence of disease progression or unacceptable toxicity After completion of 2 courses patients are reevaluated and those with stable or responding disease continue treatment for 2 courses beyond maximum response Doxorubicin is discontinued in patients who receive a maximum lifetime dose but still have stable or responding disease
Patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study over approximately 20 months
Compare the overall survival and objective response rate of patients with relapsed or refractory multiple myeloma treated with vincristine doxorubicin and dexamethasone VAD with or without PSC 833
Compare event free survival and subjective response in patients treated with these regimens
Correlate treatment outcome with p-glycoprotein expression
Determine whether prognostic factors previously determined to be useful in untreated patients ie plasma cell labeling index and multidrug resistance determined from bone marrow aspirates serum beta 2-microglobulin and interleukin-6 receptor levels correlate with objective and subjective response and event-free and overall survival in patients treated with these regimens
Compare the toxicity of VAD with or without PSC 833
OUTLINE This is a randomized multicenter study Patients are stratified by response to prior treatment prior doxorubicin andor vincristine prior autologous peripheral blood stem cell transplantation and center
Patients are randomized to 1 of 2 treatment arms
Arm I The first group receives vincristine doxorubicin and dexamethasone VAD Patients receive higher dose vincristine IV over 96 hours and higher dose doxorubicin IV over 96 hours on days 1-4 and oral dexamethasone daily on days 1-4 and 15-18
Arm II The second group receives VAD plus oral PSC 833 Patients receive oral PSC 833 every 6 hours beginning on day 1 and continuing for 20 doses Patients receive lower dose vincristine IV over 96 hours and lower dose doxorubicin IV over 96 hours on days 2-5 and oral dexamethasone daily on days 2-5 and 16-19
Treatment in both arms repeats every 4 weeks in the absence of disease progression or unacceptable toxicity After completion of 2 courses patients are reevaluated and those with stable or responding disease continue treatment for 2 courses beyond maximum response Doxorubicin is discontinued in patients who receive a maximum lifetime dose but still have stable or responding disease
Patients are followed every 2 months for survival
PROJECTED ACCRUAL A total of 360 patients will be accrued for this study over approximately 20 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S1A95 | None | None | None |
| E-1A95 | None | None | None |
| CAN-NCIC-MY8 | None | None | None |
| CLB-E1A95 | None | None | None |
| EORTC-E1A9506971 | None | None | None |
| SWOG-E1A95 | None | None | None |
| CAN-NCIC-J1A95 | None | None | None |
| CLB-9596 | None | None | None |