Multiple Myeloma Clinical Trial
Official title:
Phase II Trial of Pegylated Liposomal Doxorubicin (Doxil), Vincristine, and Dexamethasone (DVd) in Combination With Arsenic Trioxide (Trisenox) in Untreated Patients With Symptomatic Multiple Myeloma
This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.
Rationale: The chemotherapy combination of doxorubicin, vincristine and dexamethasone (DVd)
has been used with some efficacy in patients with multiple myeloma. However, DVd's efficacy
is primarily considered palliative for patients with this condition. The current study adds
arsenic trioxide to the DVd combo to assess if all of the treatments together improve
patient outcomes. Previous studies suggest that arsenic trioxide may enhance the efficacy of
specific chemotherapy agents including those in DVd; however, research in people has not yet
demonstrated this improved effectiveness. Because the safety of arsenic trioxide has been
tested in this patient population, this phase II study will gather more information about
safety and also measure efficacy through various measures.
Purpose: This study will evaluate the safety and efficacy of doxorubicin, vincristine and
dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma.
The biology of the tumor and other molecular changes will also be assessed in patients
through collections of blood and marrow samples.
Treatment: Patients in this study will receive arsenic trioxide, doxorubicin, vincristine
and dexamethasone. During the first five days of the study, patients will be given arsenic
trioxide each day through an intravenous infusion. No treatments will be provided on days
six and seven. After this first week, patients will then receive study drugs on the
following schedule every four weeks: doxorubicin and vincristine on day one, dexamethasone
on days one through four, and arsenic trioxide twice each week. This schedule can be
repeated up to four times for a total of approximately four months. Several tests and exams
will be given throughout the study to closely monitor patients. Supportive care will be
provided to help regulate side effects from study drugs and maintain quality of life in
patients. Treatments will be discontinued due to disease growth or unacceptable side
effects.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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