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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 |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00097981 |
The main purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating patients newly diagnosed with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (also called "Complete Response") will be studied to make the determination of which treatment is more effective.
Condition | Intervention | Phase |
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Cancer Multiple Myeloma |
Drug: Thalidomide and dexamethasone Drug: Thalidomide and dexamethasone plus DOXIL |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL Plus Thalidomide Plus Dexamethasone (DOXIL® -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma |
Enrollment: | 225 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Active Comparator |
Drug: Thalidomide and dexamethasone
Thalidomide 200 mg once daily and dex 40 mg on days 1-4, 9-12, 17-20. q28 days
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002: Experimental |
Drug: Thalidomide and dexamethasone plus DOXIL
Thalidomide 200 mg once daily and dex 40 mg on days 1-4, 9-12, 17-20. q28 days plus DOXIL 40 mg/m2 on day 1
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The established treatment for newly diagnosed multiple myeloma is vincristine + adriamycin + intermittent high-dose dexamethasone therapy, but it requires a 96-hour continuous infusion of conventional doxorubicin. Newer options can be administered in an out-patient setting, which is more convenient for patients. However, the optimal regimen in producing a high rate of complete response and durable response remains to be established. This is a multi-center, open-label, randomized (patients are assigned different treatments based on chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone vs. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4-12 cycles, depending on the response of their multiple myeloma to the treatment they receive (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Thalidomide + Dexamethasone treatment is as follows: Thalidomide by mouth every night without food on Days 1-28. Dosing will be gradually increased during Cycle 1: 50 mg on Days 1-7, 100 mg on Days 8-14, 150 mg on Days 15-21, and 200 mg on Days 22-28. Thereafter, 200 mg daily will be administered for all subsequent cycles. Dexamethasone will be given at 40 mg by mouth on Days 1-4, Days 9-12 and Days 17-20. DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment is as follows: Thalidomide and Dexamethasone will be administered in the same way as described for the Thalidomide + Dexamethasone treatment group. DOXIL (doxorubicin HCl liposome injection) will be administered on Day 1 via intravenous infusion of 40 mg/m2 over 60 minutes (Cycle 1 infusion is over 90 minutes). Patients will be assessed for safety and efficacy by standard evaluations for patients with multiple myeloma at each cycle. Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection) . The study hypothesis is that the DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone treatment will be more effective in the treatment of newly diagnosed multiple myeloma than the Thalidomide + Dexamethasone treatment, as measured by number of complete responses and will be generally well-tolerated.
Specific dose adjustments can be made to Thalidomide and/or DOXIL (doxorubicin HCl liposome injection) based upon toxicity. Maximum duration of study participation for patients would be 48 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Ortho Biotech Products, L.P. ( Vice President Medical Affairs Oncology/Nephrology ) |
Study ID Numbers: | CR004579 |
Study First Received: | December 1, 2004 |
Results First Received: | October 2, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00097981 |
Health Authority: | United States: Food and Drug Administration |
pegylated liposomal hydrochloride doxorubicin injection newly diagnosed multiple myeloma dexamethasone DOXIL thalidomide |
Dexamethasone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Leprostatic Agents |