Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis

Anemia Clinical Trial

Official title: Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Participants With Multiple Myeloma or Myelofibrosis

Status Terminated

Clinical Trial Summary

This phase II trial studies how well busulfan, fludarabine, donor stem cell transplant, and cyclophosphamide in treating participants with multiple myeloma or myelofibrosis. Drugs used in chemotherapy, such as busulfan, fludarabine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving busulfan and fludarabine before and cyclophosphamide after donor stem cell may work better in treating participants with multiple myeloma or myelofibrosis.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate non-relapse mortality (NRM) up to day +100.

SECONDARY OBJECTIVES:

I. To evaluate non-relapse mortality (NRM) up to day +365. II. To evaluate the incidence of acute graft versus host disease (GVHD) and chronic GVHD up to day +365 post-transplant.

III. To evaluate the overall survival and disease free survival up to 1 year. IV. To evaluate clinical response and molecular response (complete response and partial response) up to 1 year.

OUTLINE:

Participants receive busulfan intravenously (IV) over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Participants undergo hematopoietic cell transplantation (HSCT) on day 0. Participants then receive cyclophosphamide IV over 60 minutes on days 3 and 4.

After completion of study treatment, participants are followed up for 1 year. ;

Related Conditions & MeSH terms

• Anemia
• ASXL1 Gene Mutation
• EZH2 Gene Mutation
• IDH1 Gene Mutation
• IDH2 Gene Mutation
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma
• Primary Myelofibrosis
• Recurrent Plasma Cell Myeloma
• Secondary Myelofibrosis
• Thrombocytopenia

• NCT number: NCT03303950
• Study type: Interventional
• Source: University of Utah
• Status: Terminated
• Phase: Phase 2
• Start date: March 30, 2018
• Completion date: February 19, 2020