At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with stage II or III multiple myeloma meeting Salmon and Durie criteria, undergoing autologous or syngeneic hematopoietic transplantation
- ✓Measurable disease: serum monoclonal protein ≥0.2 g/dL or Bence Jones protein ≥200 mg/24 h
- ✓Performance status ECOG 0–2 or Karnofsky ≥70
- ✓Left ventricular ejection fraction ≥50%
- ✕Non-secretory myeloma or complete/near-complete response after conventional therapy
- ✕Prior autologous transplant
- ✕Planned tandem autologous/reduced-intensity allograft
- ✕Uncontrolled infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine
In Brief
A Phase 3 clinical trial evaluating melphalan, amifostine trihydrate, and 3 other interventions for Refractory Multiple Myeloma and 2 related conditions. Completed, enrolled 130 participants across 4 sites.
Detailed Summary
RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM). PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM
Study Details
Timeline
Interventions
Given IV
Given IV
Undergo PBSCT
Correlative study
Undergo transplant