Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

For patients who receive a hematopoietic cell transplant (HCT), there is a risk of developing a diarrhea secondary to the chemotherapy which we give. Diarrhea is usually harmless in healthy adults; however, in transplant patients, diarrhea can result in dehydration, negative impact on quality of life, and prolonged hospitalization. The purpose of this study was to see if Colesevelam (Welchol) and Serum-derived bovine immunoglobulin-protein (SBI) result in a change in the frequency or consistency of your bowel movements.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Entera Health, Inc
• Treatments: Antibodies; Colesevelam Hydrochloride; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• Age ≥18 years, male or female

• Diagnosis: multiple myeloma undergoing Autologous Stem Cell Transplantation (SCT)

• Planning to receive conditioning chemotherapy (Melphalan) for autologous stem cell transplantation and standard prophylactic antibiotics treatment.

• Can drink 200ml of mannitol and agrees to undergo stool, urine, and blood checks 3 times during the study.

• Agrees and able to take the investigational products or placebo starting from the day of completing conditioning therapy for a total of 4 weeks

Exclusion Criteria:

• Patients with history of inflammatory bowel disease will be excluded from the study.

• Patients with prior GI tract surgical (small or large bowel) resections

• The concurrent presence of systemic light chain amyloidosis

• Subject has known allergy or intolerance to beef or to any ingredient used in the product

• Women who are pregnant, breast-feeding and of child-bearing potential