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

NCT00201695 | Completed Phase 2 DMC

• 1 other identifier: OSU-0354
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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%.

Conditions

Multiple Myeloma

Keywords

Untreated Patients; Symptomatic

Outcome Measures

Primary Outcomes (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)

  2004-2008

Interventions

Doxil® DRUG

40 mg/m2 IV day 1

Also known as: Doxorubicin HCL liposome injection

Vincristine DRUG

1.4 mg/m2 (maximum 2 mg) IV day 1

Also known as: Oncovin

Dexamethasone DRUG

40 mg PO days 1-4

Also known as: DVd

Arsenic Trioxide DRUG

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)

Also known as: Trisenox, ATO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have Multiple Myeloma
• No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma
• ECOG performance status must be 0-2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Hofmeister CC, Jansak B, Denlinger N, Kraut EH, Benson DM, Farag SS. Phase II clinical trial of arsenic trioxide with liposomal doxorubicin, vincristine, and dexamethasone in newly diagnosed multiple myeloma. Leuk Res. 2008 Aug;32(8):1295-8. doi: 10.1016/j.leukres.2007.10.020. Epub 2007 Dec 21.

  PMID: 18082257 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Multiple Myeloma

Interventions

liposomal doxorubicin; Vincristine; Dexamethasone; Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Craig Hofmeister, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: August 1, 2008
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

US (1)