Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01510613
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2012-01-11
Brief Title:
Pomalidomide and Dexamethasone PDex in 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 Pomalidomide and Dexamethasone PDex for Previously Treated Patients With AL Amyloidosis
Status:
COMPLETED
Status Verified Date:
2018-03
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 aim of the study is to evaluate the safety and efficacy of Pomalidomide and Dexamethasone in patients who did not achieve a complete response after initial treatment with both an alkylating agent Melphalan or Cyclophosphamide and Bortezomib Patients who received 1 previous treatment without achieving a complete response CR but who could not be treated with alkylators andor Bortezomib due to contraindications will be included
Detailed Description:
This will be a phase II open-label single-arm dose-escalation study Patients with systemic AL amyloidosis who did not achieve a complete response after initial treatment with both an alkylating agent Melphalan or Cyclophosphamide and Bortezomib will be enrolled Patients who received 1 previous treatment but who could not be treated with alkylators andor Bortezomib due to contraindications will be eligible Twenty-eight patients will be enrolled in the study The patients will be treated with the combination of Pomalidomide and Dexamethasone given orally in 28 day cycles continuously ie until hematologic or organ progression or unacceptable toxicity There will be 2 dose levels of Pomalidomide 2 and 4 mgday A standard 33 dose escalation design will be used If less than 2 of 6 patient experience dose limiting toxicity at dose level 1 then all other patients will be treated at dose level 2 There will be 2 dose levels also for Dexamethasone 20 and 40 mgweek The dose of dexamethasone will be adjusted on an individual basis considering fluid retention and repetitive ventricular arrhythmias at baseline as well as Dexamethasone-related adverse events The study comprises 3 periods screening treatment with evaluations of response at the end of every single cycle followed by the end-of-treatment evaluation and follow-up After giving written informed consent subjects will be evaluated for eligibility for enrollment in the study and baseline evaluations will be performed Treatment will be continued until progression or unacceptable toxicity is observed After treatment discontinuation patients will be followed for survival and any possible Second Primary Malignancies signals for 2 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 |
|---|---|---|---|
| 2011-001787-22 | EUDRACT_NUMBER | None | None |