A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Λέξεις-κλειδιά
Αφηρημένη
Ημερομηνίες
| Τελευταία επαλήθευση: | 12/31/2019 |
| Πρώτα υποβλήθηκε: | 12/04/2018 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 12/04/2018 |
| Δημοσιεύτηκε για πρώτη φορά: | 12/05/2018 |
| Υποβλήθηκε τελευταία ενημέρωση: | 01/07/2020 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 01/09/2020 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 12/02/2018 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 05/31/2021 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 05/31/2021 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: Participants with Myeloma
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: Participants with Myeloma Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea | Drug: Participants with Myeloma 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. |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: - Memorial Sloan Kettering Cancer Center (MSK) confirmed diagnosis of multiple myeloma - Treatment with single agent lenalidomide maintenance - Patient must be >/= 18 years of age at the time of informed consent - Experiencing grade 1 or more diarrhea according to the CTCAE 5.0 criteria for at least 4 out of 7 days preceding screening and study inclusion - Scheduled to receive lenalidomide maintenance cyles at MSK - Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: - Patients with history of bowel obstruction - Patients with serum triglyceride levels >300 mg/dL - Patients wit history of hypertriglyceridemia-induced panreatitis - Patients with known hypersensitivity to colesevelam or any component to the formulation - Patients currently already receiving a bile acid sequestrant or have previously used bile acid sequestrant drugs for diarrhea and had no benefit - Patients with diarrhea secondary to infection. Infections will need to be ruled out (Clostridium difficile PCR when clinically indicated, GI pathogen panel, stool ova and parasites, Giardia and Cryptosporum stool antigen tests) prior to starting treatment in all patients. |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0 [4 weeks]
Δευτερεύοντα αποτελέσματα
1. GI symptom assessment [4 weeks]
