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Phase III Randomized Trial of Thalidomide/Dexamethasone vs VAD as Induction Chemotherapy for Newly Diagnosed Myeloma Patients and Evaluation of the Effects of Zoledronate on Chemotherapy Induced Apoptosis and Antigen Presentation.
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).
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 90 |
| Start date | 2003-06 |
| Completion | 2012-08 |
Conditions
- Multiple Myeloma
Interventions
- zoledronic acid
- dexamethasone
- thalidomide
- vincristine
- adriamycin
Primary outcomes
- Response Rates of VAD vs. Thalidomide/Dexamethasone — End of Cycle 4 - 4 Months per Participant
Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.
Countries
United States, Puerto Rico