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

NCT02619812 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 15-006205
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Stool Frequency

  Stool frequency was self reported in a daily bowel pattern diary for 30 days.

  30 days

• Stool Consistency

  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.

  30 days

Study Arms (4)

Group A: SBI + Placebo

ACTIVE COMPARATOR

Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day

Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); Other: Double Placebo

Group B: Colesevelam + Placebo

ACTIVE COMPARATOR

Colesevelam 1.875 g + Placebo twice per day

Drug: Colesevelam; Other: Double Placebo

Group C: Colesevelam + SBI

ACTIVE COMPARATOR

Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day

Other: Serum-derived bovine immunoglobulin/protein isolate (SBI); Drug: Colesevelam

Group D: Double Placebo

PLACEBO COMPARATOR

Double placebo twice per day

Other: Double Placebo

Interventions

Serum-derived bovine immunoglobulin/protein isolate (SBI) OTHER

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)

Group A: SBI + Placebo; Group C: Colesevelam + SBI

Colesevelam DRUG

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).

Also known as: Welchol

Group B: Colesevelam + Placebo; Group C: Colesevelam + SBI

Double Placebo OTHER

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).

Group A: SBI + Placebo; Group B: Colesevelam + Placebo; Group D: Double Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Entera Health, Inc: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Limitations and Caveats

This study was terminated early due to difficulty recruiting subjects; pill burden and nausea were barriers to study continuation for subjects accrued. Data were not collected.

Results Point of Contact

• Title: Michael Camilleri
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-284-6218

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 2, 2015
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)