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| Sponsors and Collaborators: |
University of Arkansas Celgene Corporation |
|---|---|
| Information provided by: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00083551 |
Purpose
This study has been designed to evaluate whether “anti-angiogenesis” therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Thalidomide Drug: Ara-C Drug: BCNU Drug: Cisplatin Drug: Cytoxan Drug: Dexamethasone Drug: Doxorubicin Drug: Etoposide Drug: Filgrastim Drug: Recombinant GM-CSF Drug: Interferon-alpha-2b Drug: Melphalan Drug: Vincristine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | UARK 98-026, Total Therapy II – A Phase III Study for Newly Diagnosed Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy |
| Estimated Enrollment: | 673 |
| Study Start Date: | August 1998 |
| Estimated Study Completion Date: | June 2010 |
Treatment will be given in 4 phases or steps: Induction, Transplant 1 and 2, Consolidation, and maintenance. Induction is designed to induce (or bring about) myeloma into remission. Each patient enrolled on this study will be randomly assigned to receive the above treatment alone or in combination with a drug called thalidomide. Some patients may be eligible to receive the transplant as an outpatient, based on general health and other factors.After recovery from the transplant phase of the study (approximately 6 weeks), patients originally assigned to thalidomide will resume taking it and will continue taking it throughout the rest of the study treatment. All patients will receive post-transplant consolidation treatment, which in earlier studies has been found to be helpful in maintaining patients response after transplant. Therefore, all patients will receive a combination of drugs called "D PACE" which consists of Dexamethasone, Cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide. If you are also taking thalidomide, you will continue taking it throughout, and the treatment is called "DT PACE" to include the thalidomide. No sooner than 4 weeks, and no later than 12 weeks after consolidation and if your myeloma remains in remission after consolidation therapy is complete, you will begin the last phase of the study, which is maintenance. Maintenance is designed to keep your myeloma in remission long-term.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences/MIRT | |
| Little Rock, Arkansas, United States, 72205 | |
| Principal Investigator: | Bart Barlogie, M.D., Ph.D. | UAMS |
More Information
| Study ID Numbers: | UARK 98-026 |
| Study First Received: | May 25, 2004 |
| Last Updated: | May 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00083551 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Cancer Therapy Thalidomide DTPACE Transplant |
VAD DCEP CAD Consolidation Melphalan |
|
Anti-Inflammatory Agents Dexamethasone Melphalan Immunologic Factors Thalidomide Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Etoposide phosphate Anti-Bacterial Agents |
Hemorrhagic Disorders Cisplatin Alkylating Agents Etoposide Cytarabine Dexamethasone acetate Interferon-alpha Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Interferons Vascular Diseases Vincristine Antimitotic Agents |
|
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal |
Hematologic Diseases Vincristine Glucocorticoids Doxorubicin Multiple Myeloma Neoplasms Interferon Alfa-2a Antineoplastic Agents, Phytogenic Interferon Alfa-2b Leprostatic Agents Melphalan Immunologic Factors Thalidomide Blood Protein Disorders Antineoplastic Agents |