At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Melphalan, Fludarabine, and 2 other interventions for Multiple Myeloma. Completed, enrolled 52 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.
Study Details
Timeline
Interventions
Arm 1 = 140 mg/m\^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m\^2 intravenous over 20 Minutes on Day -1.
30 mg/m\^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
Stem Cell Infusion on Day 0.
375 mg/m\^2 intravenous on Day -5, +2 +9 and +16.