Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215943
Status:
TERMINATED
Last Update Posted:
2014-04-17
First Post:
2005-09-15
Brief Title:
Phase III Randomized Trial of ThalidomideDexamethasone Versus VincristineAdriamycinDexamethasone VAD
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase III Randomized Trial of ThalidomideDexamethasone vs VAD as Induction Chemotherapy for Newly Diagnosed Myeloma Patients and Evaluation of the Effects of Zoledronate on Chemotherapy Induced Apoptosis and Antigen Presentation
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual changes in management of newly diagnosed myeloma patients new drugsmore effective regimens
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators planned to accrue 176 participants to compare the response rate overall response rate and survival of patients with multiple myeloma MM when randomized to two regimens thalidomideDexamethasone versus VincristineAdriamycinDexamethasone Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment ie increase in complete response rates
Detailed Description:
Patients Randomized to receive VAD vincristine adriamycin dexamethasone All patients received four cycles of VAD repeated every 4 weeks Chemotherapy was administered by continuous IV Infusion for 96 hours vincristine at a dose of 04 mgday and doxorubicin at a dose of 9 mgm2day Patients were administered dexamethasone 40 mg by mouth PO on days 1 to 4 9 to 12 and 17 to 20 of the initial two cycles Dexamethasone was given only on days 1-4 of all subsequent cycles Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle This schedule continued monthly as long as the patient remained on study The dose was calculated based on the patients monthly creatinine clearance Upon initiation of Zometa therapy the following guidelines were applied For patients with creatinine clearance 60 mLmin the recommended dose remained at 4mg For patients with reduced creatinine clearance dosing was calculated to achieve the same area under curve AUC as in patients with creatinine clearance of 75 mLmin Creatinine clearance was calculated using the Cockcroft-Gault formula
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 |
|---|---|---|---|
| CZOL446E | OTHER | Novartis | None |