drugset / Trial / NCT00215943
Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)
Phase 3
Terminated
90 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Novartis · collab
RandomizedParallel-groupOpen-labelTreatment
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 (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).
Timeline
- Start
- 2003-06
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Outcome not reported
Stopped (Enrollment): “Poor accrual, changes in management of newly diagnosed myeloma patients, new drugs/more effective regimens.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 9 mg/m2 | Intravenous |
| Comparator | Thalidomide | Other / unclassified | — | Oral |
| Comparator | Vincristine | Small molecule | 0.4 mg | Intravenous |
| Comparator | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |