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Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201695
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center

Brief Summary:
This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Doxil® Drug: Vincristine Drug: Dexamethasone Drug: Arsenic Trioxide Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : August 2008

Intervention Details:
  • Drug: Doxil®
    40 mg/m2 IV day 1
    Other Name: Doxorubicin HCL liposome injection
  • Drug: Vincristine
    1.4 mg/m2 (maximum 2 mg) IV day 1
    Other Name: Oncovin
  • Drug: Dexamethasone
    40 mg PO days 1-4
    Other Name: DVd
  • Drug: Arsenic Trioxide
    0.25 mg/kg IV over 1-4 hours twice per week, week 1-4 of each cycle (i.e., days 1 and 4; 8 and 11; 15 and 18; 22 and 25)
    Other Name: Trisenox, ATO

Primary Outcome Measures :
  1. Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM) [ Time Frame: 2004-2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201695

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
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Principal Investigator: Craig Hofmeister, MD Ohio State University
Additional Information:
Publications of Results:
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Responsible Party: Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00201695    
Other Study ID Numbers: OSU-0354
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by Craig Hofmeister, Ohio State University Comprehensive Cancer Center:
Untreated Patients
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Arsenic Trioxide
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic