At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of multiple myeloma meeting Durie and Salmon criteria, requiring therapy
- ✓In first complete/partial remission or with no objective response after initial therapy; OR in remission after subsequent therapy for disease progression
- ✓Age 18-75 years
- ✓Adequate hematologic function: Hgb ≥8 g/dL (untransfused), WBC ≥3000/μL, ANC ≥1500/μL, platelets ≥100,000/μL (untransfused)
- ✕Advanced myeloma refractory and unresponsive to salvage chemotherapy regimens
- ✕Pregnant or breastfeeding females
- ✕Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Autologous Transplantation for Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating Stem Cell Transplant, Cyclophosphamide + Mesna, and 2 other interventions for Multiple Myeloma. Completed, enrolled 363 participants across 1 site.
Detailed Summary
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
Study Details
Timeline
Interventions
As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Administered intravenously 200 mg/m\^2
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.