Ignite Creation Date:
2024-05-05 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00607581
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2008-01-22
Brief Title:
Cyclophosphamide Lenalidomide and Dexamethasone CLD for Previously Treated Patients With AL Amyloidosis
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
An Open-label Phase II Study of Cyclophosphamide Lenalidomide and Dexamethasone CLD for Previously Treated Patients With AL Amyloidosis
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The treatment of light-chain AL amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy such as cyclophosphamide steroids such as dexamethasone and drugs that stimulate the immune system such as lenalidomide
The present trial studies the efficacy and safety of the combination of cyclophosphamide lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy
The present trial studies the efficacy and safety of the combination of cyclophosphamide lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy
Detailed Description:
This study will include previously treated patients with AL amyloidosis
Primary objectives to determine the hematologic and organ response rate to the association of cyclophosphamide lenalidomide and dexamethasone CLD
Secondary objectives
to determine the safety of CLD
to determine time to response to CLD
to determine the duration of response to CLD
to assess survival of AL amyloidosis patients treated with CLD
Patients receive 28-day cycles cyclophosphamide on days 1 8 and 15 oral lenalidomide on days 1-21 and oral dexamethasone on days 1 8 15 and 22
Up to 9 courses can be performed until one of the following endpoints is met
completion of cycle 9
complete hematologic remission observed after cycle 3 or 6
partial hematologic response associated with organ response after cycle 6
no response at cycle 3 or 6 After completion of study treatment patients are followed every 3 months for up to 3 years
Primary objectives to determine the hematologic and organ response rate to the association of cyclophosphamide lenalidomide and dexamethasone CLD
Secondary objectives
to determine the safety of CLD
to determine time to response to CLD
to determine the duration of response to CLD
to assess survival of AL amyloidosis patients treated with CLD
Patients receive 28-day cycles cyclophosphamide on days 1 8 and 15 oral lenalidomide on days 1-21 and oral dexamethasone on days 1 8 15 and 22
Up to 9 courses can be performed until one of the following endpoints is met
completion of cycle 9
complete hematologic remission observed after cycle 3 or 6
partial hematologic response associated with organ response after cycle 6
no response at cycle 3 or 6 After completion of study treatment patients are followed every 3 months for up to 3 years
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 |
|---|---|---|---|
| RV-AMYL-PI-303 | None | None | None |