Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017069
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2001-06-06
Brief Title:
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
CTI 1060 A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2020-10
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 more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone
Determine the rates of overall and relapse-free survival in patients treated with this regimen
Determine the safety profile of this treatment regimen in these patients
OUTLINE Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Disease assessments are conducted every 4 weeks Patients achieving complete response CR receive 2 additional courses of therapy after initial determination of CR
Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone
Determine the rates of overall and relapse-free survival in patients treated with this regimen
Determine the safety profile of this treatment regimen in these patients
OUTLINE Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Disease assessments are conducted every 4 weeks Patients achieving complete response CR receive 2 additional courses of therapy after initial determination of CR
Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1951 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068646 | REGISTRY | None | None |
| MSKCC-01012 | None | None | None |