Full Text View
Tabular View
No Study Results Posted
Related Studies
Vincristine, DOXIL® (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
This study has been completed.
First Received: June 23, 2006   Last Updated: March 17, 2008   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Alza Corporation, DE, USA
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00344422
  Purpose

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).


Condition Intervention Phase
Myeloma Proteins
Multiple Myeloma
Myeloma
M-Protein
Drug: Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center Randomized Study of Vincristine, Doxil® and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: October 2000
Study Completion Date: June 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344422

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Alza Corporation, DE, USA
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
Study ID Numbers: CR002434
Study First Received: June 23, 2006
Last Updated: March 17, 2008
ClinicalTrials.gov Identifier: NCT00344422     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Doxorubicin
Dexamethasone
drug resistant myeloma
Pegylated Liposomal Doxorubicin
Liposomal
Anthracyclines
Vincristine
Liposomes
DOXIL

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Antibiotics, Antineoplastic
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Mitosis Modulators
Gastrointestinal Agents
Vascular Diseases
Vincristine
Antimitotic Agents
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Multiple Myeloma

ClinicalTrials.gov processed this record on February 08, 2010