Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT00091260
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2004-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
Vaishali Sanchorawala
Organization:
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 5-12.5 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 5-12.5 months.
Study Oversight
Has Oversight DMC:
True
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?: