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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201695
First received: September 12, 2005
Last updated: November 5, 2013
Last verified: November 2013

September 12, 2005
November 5, 2013
July 2004
September 2006   (final data collection date for primary 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) [ Time Frame: 2004-2008 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00201695 on ClinicalTrials.gov Archive Site
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Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma
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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2008
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201695
OSU-0354
Yes
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Craig Hofmeister, MD Ohio State University
Ohio State University Comprehensive Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP