Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
Withdrawn before enrolling · Phase 1
Conditions studied: Multiple Myeloma and Plasma Cell Neoplasm
In brief
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma.
Key facts
- Study ID
- NCT00504101
- Run by
- University of Miami
- People needed
- 0
- Starts
- 2007-06-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2016-12-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or urine protein electrophoresis) and either bone marrow biopsy and aspirate demonstrating a plasma cell count > 10% or biopsy of a bone or soft tissue mass demonstrating a plasmacytoma
- Demonstration of an indication for therapy based on symptoms (e.g., boney pain), hypercalcemia, anemia, renal insufficiency, symptomatic plasmacytomas, multiple boney lytic lesions, etc
- Stable disease or has achieved a partial remission or complete remission to pre-transplant cyto-reductive therapy
- Primary refractory disease (no response to therapy but stable) is permitted
- Candidate for high-dose chemotherapy with autologous stem cell transplantation based on stabilization of disease with preparative chemotherapy (regardless of the specific agents)
- A minimum of 2 x 10\^6 CD34+ cells/kg must be collected prior to proceeding to transplant
You may not qualify if…
- Evidence of active plasma cell leukemia
- Relapsed refractory disease (patients who have achieved at least a partial response [PR] to previous therapy and are now refractory [have not achieved a PR to subsequent therapy])
- Progressive disease on their last therapy
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- Karnofsky performance status 60-100%
- Creatinine < 3.0 mg/dL
- AST and ALT <2.5 times upper limit of normal
- Total bilirubin < 3 mg/dL
- WBC ≥ 2,000/mm³
- Platelet count ≥ 50,000/mm³
- If abnormal hematologic function is attributable to bone marrow infiltration by multiple myeloma, the principal investigator will decide on a case-by-case basis if the patient's bone marrow reserve is appropriate for this study
- Females of childbearing potential must have a negative serum pregnancy test prior to enrollment on the study and must use an effective barrier method while on the study
- Ejection fraction > 40% and no history of uncontrolled ischemic heart disease or congestive heart failure
- No evidence of cardiac amyloidosis by echocardiogram
- DLCO and FEV_1 ≥ 50%
- Exclusion criteria:
- Active peripheral neuropathy ≥ grade 2
- Recurrent supraventricular arrhythmia or any type of sustained ventricular arrhythmia or conduction block (e.g., A-V block grade II or III, left bundle branch block)
- Known HIV infection
- Pregnant or lactating women
- Underlying medical condition that could be aggravated by the treatment or life-threatening disease unrelated to myeloma as evaluated by the enrolling physician
- History of second malignancy within the past 3 years and not in complete remission from that malignancy, excluding adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or local prostate cancer
- History of preexisting neurological disorders (grade 2 or higher by the NCI Common Toxicity Criteria, in particular seizure disorders)
- PRIOR CONCURRENT THERAPY:
Where it is running
- University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
Full record on ClinicalTrials.gov
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