Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00469209
First received: May 3, 2007
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
Primary Objectives:
- To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
- To determine the effects of bortezomib on melphalan pharmacokinetics
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma |
Drug: Trisenox (Arsenic Trioxide) Drug: Velcade (Bortezomib) Drug: Melphalan Drug: Vitamin C (Ascorbic Acid) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Ascorbic acid
Sodium ascorbate
Melphalan
Arsenic trioxide
Melphalan hydrochloride
Arsenic
Bortezomib
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Patients Reaching Complete Response (CR) [ Time Frame: Baseline through Day 180, with assessments at Day 90 and Day 180 ] [ Designated as safety issue: Yes ]Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
Secondary Outcome Measures:
- Time to Toxicity [ Time Frame: Baseline to event occurence (assessed weekly first 30 days) ] [ Designated as safety issue: Yes ]The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.
| 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 |
|---|---|
|
Active Comparator: No Bortezomib
Arm 1: Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Other Name: ATO
Drug: Melphalan
100 mg/m2 by vein days -4,-3, over 30 minutes
Other Name: Alkeran
Drug: Vitamin C (Ascorbic Acid)
1000 mg once a day through the vein for 7 days.
|
|
Active Comparator: Bortezomib 1.0 mg/m^2
Arm 2: Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Other Name: ATO
Drug: Velcade (Bortezomib)
Arm 1 (Level 1): 1.0 mg/m^2 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/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Other Names:
Drug: Melphalan
100 mg/m2 by vein days -4,-3, over 30 minutes
Other Name: Alkeran
Drug: Vitamin C (Ascorbic Acid)
1000 mg once a day through the vein for 7 days.
|
|
Active Comparator: Bortezomib 1.5 mg/m^2
Arm 3: Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Drug: Trisenox (Arsenic Trioxide)
0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).
Other Name: ATO
Drug: Velcade (Bortezomib)
Arm 1 (Level 1): 1.0 mg/m^2 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/m^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Other Names:
Drug: Melphalan
100 mg/m2 by vein days -4,-3, over 30 minutes
Other Name: Alkeran
Drug: Vitamin C (Ascorbic Acid)
1000 mg 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 |
Criteria
Inclusion Criteria:
- a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
- Age up to 75 years.
- Zubrod performance status of <2.
- Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
- Serum bilirubin <2 times upper limit of normal, alanine aminotransferase/SGPT <4 times upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
- HIV-negative.
- Negative Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Corrected QT interval less than 470 msec.
Exclusion Criteria:
- Corrected QT interval greater than 470 msec.
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469209
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
| Principal Investigator: | Muzaffar H. Qazilbash, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00469209 History of Changes |
| Other Study ID Numbers: | 2005-0893 |
| Study First Received: | May 3, 2007 |
| Results First Received: | March 23, 2010 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Multiple Myeloma Melphalan Trisenox Arsenic Trioxide |
Ascorbic Acid Vitamin C Velcade Bortezomib |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Ascorbic Acid |
Vitamins Melphalan Arsenic trioxide Bortezomib Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013