At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of intermediate or advanced multiple myeloma with at least one of: intermediate-to-high M-component (IgG >5 g/dL, IgA >3 g/dL, or urine M >4 g/24h), >1 osteolytic lesion or diffuse osteoporosis, β-2 microglobulin >3, or nonsecretory with >30% bone marrow plasmacytosis
- ✓Completed autologous peripheral blood stem cell transplantation within 3-4 months prior to enrollment
- ✓Age 18-69 years
- ✓Absolute neutrophil count ≥1,000/mm³
- ✕Peripheral neuropathy grade ≥2
- ✕History of hypersensitivity to bortezomib, boron, or mannitol
- ✕Concurrent major cardiac, pulmonary, gastrointestinal, bladder, neurologic, or psychiatric disease that would preclude study participation
- ✕Dementia or significantly altered mental status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating bortezomib for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 30 participants across 1 site.
Detailed Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission. PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.