A Phase II Study of Colesevelam for Lenalidomide-Associated Diarrhea

Full Title

IIT: Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea

Purpose

Lenalidomide is a medication used as maintenance therapy after initial therapy for multiple myeloma, to reduce the risk of regrowth of myeloma cells. However, this drug can cause diarrhea. In this study, researchers are evaluating the use of colesevelam to treat diarrhea in patients on lenalidomide maintenance therapy.

Colesevelam is approved by the U.S. Food and Drug Administration for the treatment of high cholesterol; its use in this study is considered investigational. It binds to substances called bile acids and prevents them from being taken up by the intestine. Problems with bile acid absorption are believed to be a major cause of diarrhea related to lenalidomide use. Colesevelam 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 be receiving lenalidomide as maintenance therapy for multiple myeloma and be experiencing moderate to severe lenalidomide-related diarrhea.
  • 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 212-639-7986.

Protocol

18-421

Phase

II

Investigator

Co-Investigators