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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

M-Protein

Multiple Myeloma

Myeloma Proteins

Myeloma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00344422

CR002434

Details and patient eligibility

About

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).

Full 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

Enrollment

198 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.