Back to resultsA Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)
Primary Purpose
Multiple Myeloma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melphalan, Velcade, Thalidomide, Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
- Patient has measurable disease in which to capture response.
- Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
- Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
- Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dL.
- Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Male or female adults of at least 18 years of age.
- Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.
Exclusion Criteria:
- Chemotherapy or radiotherapy received within the previous 2 weeks.
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
- Platelet count < 75,000/mm3, or ANC < 1,000/μl.
- Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis.
- New York Hospital Association (NYHA) Class III or Class IV heart failure.
- Myocardial infarction within the last 6 months.
- Uncontrolled, active infection requiring IV antibiotics.
- Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
- Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
- Breast-feeding women may not participate.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VDT and Melphalan
Arm Description
To find out if three drugs, bortezomib, thalidomide, and dexamethasone in addition to high doses of melphalan (M-VTD) and autologous transplant can be given safely and effectively to subjects who have failed previous regimens with transplant(s).
Outcomes
Primary Outcome Measures
VTD regimen with melphalan
To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00577668
Brief Title
A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)
Official Title
UARK 2007-01, A Phase II Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD) and Autologous Transplantation for Patients Relapsing or Progressing After Tandem Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Poor accrual
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Detailed Description
Autologous transplant is now considered a standard treatment for many patients with multiple myeloma. An autologous transplant is a procedure in which stem cells are removed from a patient and then given back to the patient following intensive treatment. Doctors remove healthy stem cells from a patient's circulating blood system and store them before the patient receives high-dose chemotherapy. The stem cells are then returned to the patient, where they can produce new blood cells to replace cells destroyed by the treatment. The drug usually used before transplant is melphalan alone in 1 or 2 high doses. In past studies conducted at UAMS, researchers have shown that a chemotherapy treatment regimen called "VTD" is effective in patients with multiple myeloma who have failed previous treatments. VTD is a combination of drugs consisting of VelcadeTM (also known as bortezomib), Thalidomide, and Dexamethasone. In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s) can be given safely to subjects who have failed previous transplant(s).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VDT and Melphalan
Arm Type
Experimental
Arm Description
To find out if three drugs, bortezomib, thalidomide, and dexamethasone in addition to high doses of melphalan (M-VTD) and autologous transplant can be given safely and effectively to subjects who have failed previous regimens with transplant(s).
Intervention Type
Drug
Intervention Name(s)
Melphalan, Velcade, Thalidomide, Dexamethasone
Intervention Description
To assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg.
Primary Outcome Measure Information:
Title
VTD regimen with melphalan
Description
To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
Patient has measurable disease in which to capture response.
Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dL.
Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Male or female adults of at least 18 years of age.
Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.
Exclusion Criteria:
Chemotherapy or radiotherapy received within the previous 2 weeks.
Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
Platelet count < 75,000/mm3, or ANC < 1,000/μl.
Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis.
New York Hospital Association (NYHA) Class III or Class IV heart failure.
Myocardial infarction within the last 6 months.
Uncontrolled, active infection requiring IV antibiotics.
Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
Breast-feeding women may not participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Pineda-Roman, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)
We'll reach out to this number within 24 hrs