Clinical trial NCT02619812
Conditions: Multiple Myeloma
Sponsor: Mayo Clinic
Start date: 2016-04-01; Completion date: 2016-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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.

Detailed description:
This was 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.

Arms: arm 1: Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day arm 2: Colesevelam 1.875 g + Placebo twice per day arm 3: Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day arm 4: Double placebo twice per day
Interventions: intervention 1: Serum-derived bovine immunoglobulin/protein isolate (SBI) intervention 2: Colesevelam intervention 3: Double Placebo
Intervention descriptions: intervention 1: SBI 10 grams (The subject will take a total of 4 packets of SBI; taken as two packets of SBI twice a day mixed with water or blended with certain foods) intervention 2: Colesevelam 1.875 g (The subject will take a total of 12 capsules of Welchol 1.875g per day; taken as 6 capsules twice a day by mouth). intervention 3: Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).

Protocol documents: