At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis
In Brief
A Phase 2 clinical trial evaluating filgrastim, bortezomib, and 2 other interventions for Multiple Myeloma. Completed, enrolled 10 participants across 1 site.
Detailed Summary
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.
Study Details
Timeline
Interventions
16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection
1.0 mg/m2/dose D -6, D-3, D +1, D + 4
100 mg/m2/dose D -2, D -1
infusion of previously collected autologous stem cells