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| 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 |
|---|---|
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2000 |
| Study Completion Date: | June 2004 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| 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 |
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Doxorubicin Dexamethasone drug resistant myeloma Pegylated Liposomal Doxorubicin Liposomal |
Anthracyclines Vincristine Liposomes DOXIL |
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Dexamethasone Anti-Inflammatory Agents Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Vincristine Antimitotic Agents Glucocorticoids Doxorubicin Multiple Myeloma Tubulin Modulators Peripheral Nervous System Agents Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Neoplasms, Plasma Cell |
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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 |