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| Sponsored by: |
University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00581919 |
Purpose
Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib, Dexamethasone, Doxorubicin, Acetyl-L-Carnitine (ALCAR) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
The primary objective of this study is to assess overall response rate to the treatment.
Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.
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| Contact: Cancer Connect | 800 622-8922 | uwccc@uwccc.wisc.edu |
| United States, Wisconsin | |
| University of Wisconsin Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Natalie S Callander, MD 608-263-1836 nsc@medicine.wisc.edu | |
More Information
| Responsible Party: | University of Wisconsin ( Natalie Callander ) |
| Study ID Numbers: | HO04402 |
| Study First Received: | December 19, 2007 |
| Last Updated: | October 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00581919 |
| Health Authority: | United States: Institutional Review Board |
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previously treated multiple myeloma |
|
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Carnitine Acetylcarnitine Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Vitamins Therapeutic Uses Cardiovascular Diseases Micronutrients Nootropic Agents Vitamin B Complex |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
