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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Cephalon |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00469209 |
Purpose
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma |
Drug: Trisenox (Arsenic Trioxide) Drug: Velcade (Bortezomib) Drug: Melphalan Drug: Vitamin C (Ascorbic Acid) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma |
| Enrollment: | 60 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Melphalan + Arsenic Trioxide + Vitamin C
|
Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Drug: Melphalan
100 mg/m2 by vein days -4,-3, over 30 minutes
Drug: Vitamin C (Ascorbic Acid)
Once a day through the vein for 7 days.
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2: Active Comparator
Melphalan + Arsenic Trioxide + Vitamin C + Bortezomib (Level 1)
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Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Drug: Velcade (Bortezomib)
Arm 1 (Level 1): 1.0 mg/m2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
100 mg/m2 by vein days -4,-3, over 30 minutes
Drug: Vitamin C (Ascorbic Acid)
Once a day through the vein for 7 days.
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|
3: Active Comparator
Melphalan + Arsenic Trioxide + Vitamin C + Bortezomib (Level 2)
|
Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Drug: Velcade (Bortezomib)
Arm 1 (Level 1): 1.0 mg/m2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
100 mg/m2 by vein days -4,-3, over 30 minutes
Drug: Vitamin C (Ascorbic Acid)
Once a day through the vein for 7 days.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Muzaffar H. Qazilbash, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Muzaffar H. Qazilbash, MD/Associate Professor ) |
| Study ID Numbers: | 2005-0893 |
| Study First Received: | May 3, 2007 |
| Last Updated: | October 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00469209 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Multiple Myeloma Melphalan Trisenox Arsenic Trioxide |
Ascorbic Acid Vitamin C Velcade Bortezomib |
|
Melphalan Antioxidants Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances Bortezomib Vascular Diseases Arsenic trioxide Enzyme Inhibitors Immunosuppressive Agents Protective Agents Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms |