Rochester, Minnesota 55905


Purpose:

To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.


Study summary:

This is a randomized, double-blind, placebo-controlled pilot study of SBI, colesevelam, and placebo in patients undergoing autologous HSCT for the clinical care of multiple myeloma. The number of adults undergoing hematopoietic stem cell transplant (HSCT) has grown significantly over the past two decades as a result of the availability of therapies for advanced hematologic and solid tumor malignancies, and the broader selection criteria for eligibility to receive these transplants. Generally, the stem cell transplant procedure consists of administration of chemotherapy and/or radiation therapy to ablate all residual malignancy (called conditioning therapy), followed by intravenous infusion of hematopoietic stem cells to restore bone marrow function. Generally, HSCT has a positive effect on survival, despite serious adverse effects and life-threatening complications. Diarrhea can affect up to 91% of patients receiving autologous or allogeneic HSCT and is identified by 9% of the patients as the single most debilitating adverse effect post-HSCT. Other commonly encountered symptoms are nausea and vomiting (13%) and mouth sores (42%). The impact of diarrhea can be significant and result in dehydration, negative impact on quality of life, prolonged hospitalization with an increased cost and risk, and the diarrhea may be potentially life-threatening.


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


NCT ID:

NCT02619812


Primary Contact:

Principal Investigator
Michael Camilleri, MD
Mayo Clinic

Lori Rhodes
Phone: 507-266-1944
Email: RSTDOMCTU@mayo.edu


Backup Contact:

Email: boldingh.amy@mayo.edu
Amy M Boldingh
Phone: 507-538-6599


Location Contact:

Rochester, Minnesota 55905
United States

Lori Rhodes
Phone: 507-266-1944
Email: RSTDOMCTU@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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