A Study of Colesevelam for Lenalidomide-Associated Diarrhea

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 3, 2018

Primary Completion Date

November 27, 2024

Study Completion Date

November 27, 2024

Conditions
Multiple MyelomaDiarrhea
Interventions
DRUG

Colesevelam Pill

For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03767257 - A Study of Colesevelam for Lenalidomide-Associated Diarrhea | Biotech Hunter | Biotech Hunter