Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091260
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2004-09-07
Brief Title:
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
Vaishali Sanchorawala
Organization:
Boston Medical Center
Study Overview
Official Title:
A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis
PURPOSE This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis
PURPOSE This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Primary
Determine the tolerability of CC-5013 in patients with primary systemic AL amyloidosis
Determine the objective hematologic response rate in patients treated with this drug
Determine amyloid organ disease response in patients treated with this drug
Secondary
Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone
Determine the toxicity of CC-5013 in combination with dexamethasone in these patients
OUTLINE Patients receive oral CC-5013 once daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4 9-12 and 17-20 of every other 28-day course for up to 6 courses of combination therapy Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study
Patients are followed annually
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 5-125 months
Primary
Determine the tolerability of CC-5013 in patients with primary systemic AL amyloidosis
Determine the objective hematologic response rate in patients treated with this drug
Determine amyloid organ disease response in patients treated with this drug
Secondary
Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone
Determine the toxicity of CC-5013 in combination with dexamethasone in these patients
OUTLINE Patients receive oral CC-5013 once daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4 9-12 and 17-20 of every other 28-day course for up to 6 courses of combination therapy Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study
Patients are followed annually
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 5-125 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 |
|---|---|---|---|
| CELGENE-RV-AMYL-PI-003 | OTHER_GRANT | Celgene | None |
| BUMC-H-23235 | OTHER | None | None |