Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01432600
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2011-09-09
Brief Title:
Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma
Status:
COMPLETED
Status Verified Date:
2017-02
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 main purpose of this study is to see whether pomalidomide can help people with myeloma Researchers also want to find out if pomalidomide is safe and tolerable
Detailed Description:
There are two parts to this study
Phase 1 To determine a safe dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone
Phase 2 To see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide for the treatment of participants who have myeloma which has relapsed to or become refractory not responding to prior treatment
Phase 1 To determine a safe dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone
Phase 2 To see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide for the treatment of participants who have myeloma which has relapsed to or become refractory not responding to prior treatment
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 |
|---|---|---|---|
| PO-MM-PI-0039 | OTHER_GRANT | Celgene | None |