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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
VTD regimen with melphalan
Outcome 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).
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Mauricio Pineda-Roman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Arkansas
Authority:
United States: Institutional Review Board
Study ID:
2007-01
NCT ID:
NCT00577668
Start Date:
April 2007
Completion Date:
April 2009
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
