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

• ClinicalTrials.gov Identifier: NCT02619812
• Recruitment Status: Terminated
• First Posted: December 2, 2015
• Results First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Sponsor: Mayo Clinic
• Collaborator: Entera Health, Inc
• Information provided by (Responsible Party): Michael Camilleri, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); Drug: Colesevelam; Other: Double Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized, Placebo-Controlled, Pilot Study of Colesevelam and Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Diarrhea in Patients With Multiple Myeloma Receiving Conditioning Chemotherapy for Autologous Stem Cell Transplantation (SCT)
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group A: SBI + Placebo; Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day	Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); 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); Other: Double Placebo; 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).
Active Comparator: Group B: Colesevelam + Placebo; Colesevelam 1.875 g + Placebo twice per day	Drug: Colesevelam; 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).; Other Name: Welchol; Other: Double Placebo; 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).
Active Comparator: Group C: Colesevelam + SBI; Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day	Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); 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); Drug: Colesevelam; 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).; Other Name: Welchol
Placebo Comparator: Group D: Double Placebo; Double placebo twice per day	Other: Double Placebo; 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).

Outcome Measures

Primary Outcome Measures :

1. Stool Frequency [ Time Frame: 30 days ]
   Stool frequency was self reported in a daily bowel pattern diary for 30 days.
2. Stool Consistency [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Entera Health, Inc

Investigators

• Principal Investigator: Michael Camilleri, MD; Mayo Clinic

More Information

• Responsible Party: Michael Camilleri, Professor of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02619812
• Other Study ID Numbers: 15-006205
• First Posted: December 2, 2015
• Results First Posted: June 14, 2017
• Last Update Posted: June 14, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Diarrhea; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms, Digestive; Colesevelam Hydrochloride; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunologic Factors; Physiological Effects of Drugs; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents