Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344422
• Other study ID #: CR002434
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2006
• Last updated: June 8, 2011
• Start date: October 2000
• Est. completion date: June 2004

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).

Description:

This is a randomized, open label study comparing the efficacy, clinical benefit, toxicity and safety of the combination of Vincristine, DOXIL® (doxorubicin HCl liposome injection), and Dexamethasone (VDD) to the standard regimen of Vincristine, Doxorubicin and Dexamethasone (VAD) in patients with newly diagnosed multiple myeloma. Approximately 200 patients with newly diagnosed multiple myeloma will be randomized to receive either VDD or VAD. This study will determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs. VAD. This study will also evaluate and compare the clinical benefit of VDD vs. VAD for the following measures: Hospitalization; Documented sepsis; Antibiotic use; Grade 3 or 4 neutropenia or neutropenic fever.

VDD: Vincristine 1.4 mg/m2 IV on Day 1; Doxil® 40 mg/m2 IV on Day 1; Dexamethasone 40 mg/day oral Days 1-4; VAD: Vincristine 0.4 mg/day continuous infusion Days 1-4; Doxorubicin 9.0 mg/m2/day continuous infusion Days 1-4; Dexamethasone 40 mg/day orally on Days 1-4; Every 28 days for 4 cycles

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Untreated multiple myeloma requiring treatment

• Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2

• Must have measurable disease

• Left Ventricular Ejection Fraction (LVEF) >= 50 % determined by Multiple Gated Acquisition Scan (MUGA)

• Karnofsky performance status of >= 60%

• Adequate bone marrow, liver and renal function

• Disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control.

Exclusion Criteria:

• Life expectancy of >= 3 months

• Pregnant or breast feeding

• History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure

• or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months

• Uncontrolled diabetes mellitus or systemic infection

• Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma

• Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent

• Prior chemotherapy to treat Multiple Myeloma

• Prior radiotherapy to an area greater than 1/3 of the skeleton

• Prior local radiotherapy within 1 week of treatment

• Any investigational agent within 30 days of the first dose of treatment

• Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• M-Protein
• Multiple Myeloma
• Myeloma
• Myeloma Proteins
• Neoplasms, Plasma Cell

Intervention

Drug:
• Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

References & Publications (1)

Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs VAD.
Secondary	To evaluate and compare the clinical benefit of VDD vs VAD for the following measures: Hospitalization, Documented sepsis,Antibiotic use, Grade 3 or 4 neutropenia or neutropenic fever

External Links

•   A Multi-Center Randomized Study of Vincristine, DOXIL and Dexamethasone vs. Vincristine Doxorubicin, and Dexamethasone in Patients with Multiple Myeloma