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

Phase 2

Terminated

Interventions: Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
Drug: Colesevelam
Other: Double Placebo

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group A: SBI + Placebo	Double Placebo	Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
Group A: SBI + Placebo	Serum-derived bovine immunoglobulin/protein isolate (SBI)	Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
Group C: Colesevelam + SBI	Serum-derived bovine immunoglobulin/protein isolate (SBI)	Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day
Group B: Colesevelam + Placebo	Double Placebo	Colesevelam 1.875 g + Placebo twice per day
Group D: Double Placebo	Double Placebo	Double placebo twice per day
Group B: Colesevelam + Placebo	Colesevelam	Colesevelam 1.875 g + Placebo twice per day
Group C: Colesevelam + SBI	Colesevelam	Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day

Primary Outcome Measures

Name	Time	Method
Stool Consistency	30 days	The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.
Stool Frequency	30 days	Stool frequency was self reported in a daily bowel pattern diary for 30 days.

Secondary Outcome Measures