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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.


Inclusion Criteria:



- Must have Multiple Myeloma

- No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple
Myeloma

- ECOG performance status must be 0-2

Exclusion Criteria:

- Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan.

- QT interval ≥480 msec on baseline ECG.

- No history of cardiac disease.

- Pregnant or breast-feeding.

- No history of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin HCL or the components of Doxil.

- History of prior or concurrent malignancy or myelodysplasia.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM)

Outcome Time Frame:

2004-2008

Safety Issue:

Yes

Principal Investigator

Craig Hofmeister, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

OSU-0354

NCT ID:

NCT00201695

Start Date:

July 2004

Completion Date:

August 2008

Related Keywords:

  • Multiple Myeloma
  • Untreated Patients
  • Symptomatic
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Ohio State University Columbus, Ohio  43210