drugset / Trial / NCT00793572

Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma

NCT00793572 ↗

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side-effects and anti-cancer effects of giving an autologous or syngeneic stem cell transplant followed by an allogeneic donor stem cell transplant and bortezomib. Patients treated on this trial have newly diagnosed high-risk, relapsed, or refractory multiple myeloma (MM). Giving chemotherapy before an autologous stem cell transplant slows or stops the growth of cancer cells by preventing them from dividing or killing them. Stem cells that were harvested earlier from the patient's blood and frozen are then returned to the patient to replace the blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy and total-body irradiation before an allogeneic donor stem cell transplant also prevents the patient's immune system from rejecting the donor's stem cells. Undergoing an autologous or syngeneic stem cell transplantation followed by an allogeneic donor stem cell transplant and bortezomib may be overall more effective in killing cancer cells.

Timeline

Start
2008-10
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.6 mg/m2 Subcutaneous
Subject Bortezomib Small molecule 2.6 mg/m2 Subcutaneous
Background Cyclosporine Peptide — Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Melphalan Small molecule 200 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule — Oral

Indications