Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma; Myeloma; M-Protein; Myeloma Proteins
Intervention: Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD) (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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).
Official title: A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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
Locations and Contacts
A Multi-Center Randomized Study of Vincristine, DOXIL and Dexamethasone vs. Vincristine Doxorubicin, and Dexamethasone in Patients with Multiple Myeloma
Starting date: October 2000
Last updated: June 8, 2011