M-Protein, Multiple Myeloma, Myeloma, Myeloma Proteins
Conditions
Keywords
Anthracyclines, Liposomes, Liposomal, Vincristine, Doxorubicin, Dexamethasone, Pegylated Liposomal Doxorubicin, DOXIL, drug resistant myeloma
Brief 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).
Detailed 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
Interventions
DRUGVincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
Sponsors
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed