Multiple Myeloma Clinical Trial
Official title:
A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).
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
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