A Phase 2 Study of Melphalan With or Without Siltuximab in Older People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Full Title

Phase II Randomized Trial of Population PK dosed Melphalan with Interleukin-6 Blockade with Siltuximab vesrus BSA based Melphalan in Patients with Multiple Myeloma Over age 60 Undergoing Autologous Stem Cell Transplantation

Purpose

Autologous stem cell transplant (ASCT) is a standard treatment for multiple myeloma. An ASCT replaces the blood-forming cells destroyed by disease or treatment with healthy cells collected from your blood. Before ASCT, people generally receive a standard drug, melphalan, to prepare the body for the transplant.

Researchers want to learn if a newer way to calculate the melphalan dose (called population pharmacokinetic [PK] dosing) works as well as the standard way. They will also see if siltuximab in combination with population PK dosing of melphalan decreases symptoms after ASCT.

The standard melphalan dosing approach is based on height and weight. Population PK dosing uses information based on people who previously received melphalan and personalizes the melphalan dose to each person.

Siltuximab blocks a protein called IL-6, which is involved in inflammation. Because higher doses of melphalan can lead to higher levels of IL-6, siltuximab plus melphalan may decrease symptoms after ASCT. If you join this study, you will receive either PK-dosed melphalan and siltuximab, or melphalan given using standard dosing.

Who Can Join

To join this study, there are a few conditions. You must:

• Have multiple myeloma and be planning to have ASCT.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 60 or older.

Contact

For more information or to see if you can join this study, please call Dr. Gunjan Shah’s office at 646-608-3734.