Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021359
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2001-07-11
Brief Title:
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-07
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 used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin II Determine the toxicity of this regimen in these patients III Correlate the changes in serum interleukin IL-6 IL-6R and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen
OUTLINE Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 and oral isotretinoin daily Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression insufficient response or unacceptable toxicity Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein for a minimum of 6 courses total
PROJECTED ACCRUAL A total of 18-36 patients will be accrued for this study within 3 years
OUTLINE Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 and oral isotretinoin daily Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression insufficient response or unacceptable toxicity Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein for a minimum of 6 courses total
PROJECTED ACCRUAL A total of 18-36 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-G01-1985 | OTHER_GRANT | NCI | None |
| FCCC-95043 | OTHER | None | None |