A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma
This is a randomized, open label study comparing the efficacy, clinical benefit, toxicity
and safety of the combination of Vincristine, DOXIL® (doxorubicin HCl liposome injection),
and Dexamethasone (VDD) to the standard regimen of Vincristine, Doxorubicin and
Dexamethasone (VAD) in patients with newly diagnosed multiple myeloma. Approximately 200
patients with newly diagnosed multiple myeloma will be randomized to receive either VDD or
VAD. This study will determine and compare the objective response rate (the percentage of
patients who attain an Objective Status of Complete Remission, Remission or Partial
Remission) for patients receiving VDD vs. VAD. This study will also evaluate and compare
the clinical benefit of VDD vs. VAD for the following measures: Hospitalization; Documented
sepsis; Antibiotic use; Grade 3 or 4 neutropenia or neutropenic fever.
VDD: Vincristine 1.4 mg/m2 IV on Day 1; Doxil® 40 mg/m2 IV on Day 1; Dexamethasone 40 mg/day
oral Days 1-4; VAD: Vincristine 0.4 mg/day continuous infusion Days 1-4; Doxorubicin 9.0
mg/m2/day continuous infusion Days 1-4; Dexamethasone 40 mg/day orally on Days 1-4; Every 28
days for 4 cycles
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs VAD.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration