A Phase II Study Evaluating a Short Course of Daratumumab in Patients with Multiple Myeloma

Full Title

IIT: Short Course Daratumumab in Minimal Residual Disease (MRD) Positive Myeloma Patients After Induction Therapy With/Without Consolidative High Dose Chemotherapy/Autologous Stem Cell Support

Purpose

Daratumumab is approved for treating multiple myeloma in patients who have received at least three prior treatments. It targets a protein called CD38, which is found in myeloma cells, and causes cancer cell death. In this study, researchers want to evaluate the effectiveness of a short course (six months) of daratumumab plus the drug lenalidomide in patients with multiple myeloma who have had only induction therapy with or without stem cell transplantation and have evidence of myeloma cells remaining in the body (“minimal residual disease” or MRD). The information doctors learn this study will be used to determine treatment options for MRD in myeloma.

Lenalidomide has already been approved as maintenance treatment for newly diagnosed multiple myeloma. Combining daratumumab with lenalidomide and dexamethasone is approved for myeloma patients who have had one to three previous treatments for myeloma; its use in this study is considered investigational. Daratumumab is given intravenously (by vein), and lenalidomide is taken orally (by mouth).

Eligibility

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

  • Patients must have multiple myeloma and a good response to induction chemotherapy, with or without stem cell transplantation, and evidence of MRD after this treatment.
  • Patients must have been on lenalidomide maintenance therapy for at least 6 months at the time of entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sham Mailankody at 212-639-2131.

Protocol

18-048

Phase

II

Investigator

Co-Investigators