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

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.

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