A Phase I/II Study of GSK2857916 with Lenalidomide plus Dexamethasone or Bortezomib plus Dexamethasone for People with Recurrent or Persistent Multiple Myeloma

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Full Title

A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 6)

Purpose

The purpose of this study is to find the best dose of the investigational drug GSK2857916 that can be given with lenalidomide and dexamethasone or with bortezomib and dexamethasone in patients whose multiple myeloma has come back or persisted despite treatment. Lenalidomide, bortezomib, and dexamethasone are standard treatments for multiple myeloma.

GSK2857916 is an antibody attached to a drug. The antibody binds to another protein called BCMA, which is found on myeloma cells. After the antibody binds to it, the myeloma cell may be damaged by the drug attached to the antibody.

GSK2857916 is given intravenously (by vein). Bortezomib is given by injection, and lenalidomide and dexamethasone are 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 that came back or persists despite prior treatment.
  • Patients must have had an autologous stem cell transplant or be ineligible for this treatment.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Malin Hultcrantz at 646-608-3714.

Protocol

19-446

Phase

I/II

Investigator

Co-Investigators