This phase II trial studies the side effects and how well colesevelam works in treating lenalidomide-associated diarrhea in patients with multiple myeloma. Bile acid malabsorption is thought to be a major cause of lenalidomide-associated diarrhea. Colesevelam binds to bile acids and may inhibit them from being taken up by the intestine and improve bile acid malabsorption.
Additional locations may be listed on ClinicalTrials.gov for NCT03767257.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the ability of colesevelam hydrochloride (colesevelam) to improve lenalidomide-associated diarrhea in patients with multiple myeloma treated with lenalidomide maintenance.
SECONDARY OBJECTIVES:
I. To assess gastrointestinal (GI) symptoms using the Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
II. To assess diet before and while on treatment with colesevelam.
III. To further describe diarrhea during the study period using the Bristol Stool Form Scale.
IV. Describe duration of response by week 12 (end of study).
CORRELATIVE OBJECTIVES:
I. To assess lenalidomide pharmacokinetics while on colesevelam.
II. Collection of research stool samples for GI microbiota and bile acid assessment.
OUTLINE:
Patients receive colesevelam hydrochloride orally (PO) once daily (QD) or twice daily (BID) for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients who respond to colesevelam hydrochloride may continue treatment after the 12 weeks of study treatment.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMalin Hultcrantz
