At a glance
ClinicalIndex Comparison Record- ✓Multiple myeloma Stage II or III with serum M-protein (IgG/IgA/IgD/IgE) >1.0 g/dL or urine M-protein ≥200 mg/24 hours
- ✓Histologically confirmed primary systemic amyloidosis without severe cardiac involvement
- ✓Light Chain Deposition Disease with evidence of plasma cell dyscrasia
- ✓Diagnosed within the past year
- ✕IgM monoclonal peak (unless physiologic criteria support myeloma diagnosis)
- ✕Monoclonal gammopathy of undetermined significance
- ✕Indolent or smoldering myeloma
- ✕Disease progression on prior thalidomide or dexamethasone
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)
In Brief
A Phase 2 clinical trial evaluating filgrastim, cyclophosphamide, and 4 other interventions for Multiple Myeloma and Plasma Cell Myeloma. Completed, enrolled 104 participants across 35 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis.