Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017602
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2001-06-06
Brief Title:
Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Genta Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Study of Dexamethasone With or Without Genasense Bcl-2 Antisense Oligonucleotide in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2003-08
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 cancer cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of dexamethasone by making cancer cells more sensitive to the drug It is not yet known if dexamethasone is more effective with or without oblimersen in treating multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of dexamethasone with or without oblimersen in treating patients who have relapsed or refractory multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of dexamethasone with or without oblimersen in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Compare the time to disease progression in patients with relapsed or refractory multiple myeloma treated with dexamethasone with or without oblimersen
Compare the duration of response and objective response rate in patients treated with these regimens
Compare the proportion of patients without disease progression after 6 months and the proportion of patients who have not discontinued treatment after 6 months in these two patient groups
Compare the safety of these regimens in these patients
Compare survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to response to prior therapy relapsed vs refractory prior autologous stem cell transplantation yes vs no and number of prior therapy regimens 1-2 vs 3-6 Patients are randomized to 1 of 2 treatment arms
Arm I
Induction Patients receive oblimersen G3139 IV continuously on days 1-7 and 15-21 and oral dexamethasone daily on days 4-7 11-14 and 18-21
Maintenance One week after completion of induction therapy patients with stable or responsive disease receive G3139 IV continuously on days 1-7 and oral dexamethasone daily on days 4-7 Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity
Arm II
Induction Patients receive oral dexamethasone daily for 4 days on weeks 1-3
Maintenance One week after completion of induction therapy patients with stable or responsive disease receive oral dexamethasone daily for 4 days Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study
Compare the time to disease progression in patients with relapsed or refractory multiple myeloma treated with dexamethasone with or without oblimersen
Compare the duration of response and objective response rate in patients treated with these regimens
Compare the proportion of patients without disease progression after 6 months and the proportion of patients who have not discontinued treatment after 6 months in these two patient groups
Compare the safety of these regimens in these patients
Compare survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to response to prior therapy relapsed vs refractory prior autologous stem cell transplantation yes vs no and number of prior therapy regimens 1-2 vs 3-6 Patients are randomized to 1 of 2 treatment arms
Arm I
Induction Patients receive oblimersen G3139 IV continuously on days 1-7 and 15-21 and oral dexamethasone daily on days 4-7 11-14 and 18-21
Maintenance One week after completion of induction therapy patients with stable or responsive disease receive G3139 IV continuously on days 1-7 and oral dexamethasone daily on days 4-7 Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity
Arm II
Induction Patients receive oral dexamethasone daily for 4 days on weeks 1-3
Maintenance One week after completion of induction therapy patients with stable or responsive disease receive oral dexamethasone daily for 4 days Courses repeat every 3 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UF-G-29-2001 | None | None | None |
| GENTA-GMY302 | None | None | None |