Conditions: Hematologic Neoplasms Multiple Myeloma Anemia, Aplastic Hemoglobinuria, Paroxysmal Myelofibrosis
Keywords: Hematologic malignancies lymphoma, leukemia, MDS (myelodysplastic syndrome) reduced-intensity preparative regimen allogeneic peripheral blood stem cell transplant myelofibrosis or other myeloproliferative syndromes
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

Detailed description:
Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Arms:
arm 1: Three drug regimen using busulfan, and melphalan, and alemtuzumab.

Interventions: intervention 1: busulfan, and melphalan, and alemtuzumab
Intervention descriptions: intervention 1: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).

intravenous melphalan 100 mg/m2 on day -3.

intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.

Protocol document: