Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049374
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2002-11-12
Brief Title:
Oblimersen Thalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-10
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 Thalidomide may slow the growth of cancer cells Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Determine the clinical efficacy of oblimersen thalidomide and dexamethasone in terms of complete and partial response rates in patients with relapsed or refractory multiple myeloma
Determine the time to progression and duration of response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Correlate disease response clinical outcome with changes in Bcl-2 levels in patients treated with this regimen
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE Patients receive induction therapy comprising oblimersen IV continuously on days 1-7 22-28 and 43-49 oral dexamethasone on days 4-7 25-28 and 46-49 and oral thalidomide daily beginning on day 4 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7 oral dexamethasone on days 4-7 and oral thalidomide daily Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 10-46 patients will be accrued for this study within 10 months
Determine the clinical efficacy of oblimersen thalidomide and dexamethasone in terms of complete and partial response rates in patients with relapsed or refractory multiple myeloma
Determine the time to progression and duration of response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Correlate disease response clinical outcome with changes in Bcl-2 levels in patients treated with this regimen
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE Patients receive induction therapy comprising oblimersen IV continuously on days 1-7 22-28 and 43-49 oral dexamethasone on days 4-7 25-28 and 46-49 and oral thalidomide daily beginning on day 4 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7 oral dexamethasone on days 4-7 and oral thalidomide daily Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 10-46 patients will be accrued for this study within 10 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 |
|---|---|---|---|
| NCI-5824 | None | None | None |
| MSGCC-210421 | None | None | None |