At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed multiple myeloma (bone marrow biopsy ≥10% plasmacytosis, or osteolytic lesion/soft tissue biopsy, or bone marrow <10% with ≥1 bony lesion)
- ✓Detectable serum M-component (IgG, IgA, IgD, or IgE) at diagnosis or urine light chain protein ≥1.0 gm/24 hrs for light chain disease
- ✓Prior autologous stem cell transplantation with high-dose melphalan (200 mg/m²) within 60-100 days before study entry
- ✓Transplantation received within 1 year of initial chemotherapy for multiple myeloma
- ✕Prior thalidomide therapy
- ✕Prior double autologous or allogeneic hematopoietic stem cell transplantation
- ✕Prior spontaneous deep vein thrombosis within past 5 years (catheter-associated thrombosis allowed)
- ✕Prior pulmonary embolism within past 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating prednisone and thalidomide for Multiple Myeloma and Plasma Cell Neoplasm. Completed, enrolled 332 participants across 18 sites.
Detailed Summary
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.
Study Details
Timeline
Interventions
Given orally
Given orally