Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112879
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2005-06-02
Brief Title:
Arsenic Trioxide Ascorbic Acid Dexamethasone and Thalidomide in Treating Patients With Multiple Myeloma
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide Ascorbic Acid Dexamethasone and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2006-12
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 such as arsenic trioxide and dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer Giving arsenic trioxide together with ascorbic acid dexamethasone and thalidomide may kill more cancer cells
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid dexamethasone and thalidomide work in treating patients with multiple myeloma
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid dexamethasone and thalidomide work in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with previously untreated high-risk or relapsed or refractory multiple myeloma MM treated with arsenic trioxide ascorbic acid dexamethasone and thalidomide
Determine the safety of this regimen in these patients
Secondary
Determine the duration of response progression-free survival and overall survival of patients with previously untreated high-risk MM treated with this regimen
OUTLINE This is an open-label study
Induction therapy Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1-5 in week 1 and then twice weekly in weeks 2-12 oral dexamethasone on days 1-4 11-14 29-32 39-42 57-60 and 67-70 weeks 1 2 5 6 9 and 10 and oral thalidomide once daily in weeks 1-12
Consolidation therapy Beginning 4 weeks after completion of induction therapy patients receive arsenic trioxide and ascorbic acid as in induction therapy oral dexamethasone on days 1-4 29-32 and 57-60 weeks 1 5 and 9 and oral thalidomide once daily in weeks 1-12
Maintenance therapy Beginning 4 weeks after completion of consolidation therapy patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1 8 15 and 22 Treatment with arsenic trioxide and ascorbic acid repeats every 90 days every 12 weeks Patients also receive oral dexamethasone on days 1-4 Treatment with dexamethasone repeats every 28 days Patients receive oral thalidomide once daily Maintenance therapy continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 6 months thereafter
PROJECTED ACCRUAL A total of 33-68 patients 15-34 with previously untreated high-risk multiple myeloma MM and 18-34 with relapsed or refractory MM will be accrued for this study
Primary
Determine the response rate in patients with previously untreated high-risk or relapsed or refractory multiple myeloma MM treated with arsenic trioxide ascorbic acid dexamethasone and thalidomide
Determine the safety of this regimen in these patients
Secondary
Determine the duration of response progression-free survival and overall survival of patients with previously untreated high-risk MM treated with this regimen
OUTLINE This is an open-label study
Induction therapy Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1-5 in week 1 and then twice weekly in weeks 2-12 oral dexamethasone on days 1-4 11-14 29-32 39-42 57-60 and 67-70 weeks 1 2 5 6 9 and 10 and oral thalidomide once daily in weeks 1-12
Consolidation therapy Beginning 4 weeks after completion of induction therapy patients receive arsenic trioxide and ascorbic acid as in induction therapy oral dexamethasone on days 1-4 29-32 and 57-60 weeks 1 5 and 9 and oral thalidomide once daily in weeks 1-12
Maintenance therapy Beginning 4 weeks after completion of consolidation therapy patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1 8 15 and 22 Treatment with arsenic trioxide and ascorbic acid repeats every 90 days every 12 weeks Patients also receive oral dexamethasone on days 1-4 Treatment with dexamethasone repeats every 28 days Patients receive oral thalidomide once daily Maintenance therapy continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 6 months thereafter
PROJECTED ACCRUAL A total of 33-68 patients 15-34 with previously untreated high-risk multiple myeloma MM and 18-34 with relapsed or refractory MM 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 |
|---|---|---|---|
| CDR0000428248 | REGISTRY | None | None |
| CCF-IRB-5241 | None | None | None |
| CCF-CTI-T12016 | Registry Identifier | PDQ Physician Data Query | None |