A Phase I Study of Tremelimumab and Durvalumab Immunotherapy with High-Dose Chemotherapy and Autologous Stem Cell Transplant for Multiple Myeloma

Full Title

A Phase 1 Study to Assess Safety and Tolerability of Tremelimumab and Durvalumab, Administered with High Dose Chemotherapy and Autologous Stem Cell Transplant (HDT/ASCT)(LUD2014-010)

Purpose

Using a patient's own blood-forming cells (special cells called "stem cells") to help increase blood counts after high doses of chemotherapy is called autologous stem cell transplantation (ASCT). ASCT is a treatment approach for patients with multiple myeloma. Patients may also receive "maintenance therapy" with anticancer drugs to reduce the chance that the myeloma will come back.

Researchers in this study are looking to find the best way to boost the immune system against multiple myeloma using the "checkpoint inhibitor" immunotherapy drugs tremelimumab and durvalumab with high-dose chemotherapy and ASCT. Checkpoint therapy will be given before and for two cycles after ASCT, followed by up to five additional monthly cycles of durvalumab alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma.
  • Patients must be eligible to receive ASCT.
  • Patients may have had up to four prior regimens of chemotherapy for multiple myeloma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Chung at 212-639-6617.

Protocol

16-1329

Phase

I

Investigator

Co-Investigators

Locations