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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02619812
• Other study ID #: 15-006205
• Status: Recruiting
• Phase: Phase 2
• First received: November 19, 2015
• Last updated: May 2, 2016
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2016
• Source: Mayo Clinic
• Contact: Lori Rhodes
• Phone: 507-266-1944
• Email: RSTDOMCTU[@]mayo.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• SBI
SBI 10 grams (You 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
Welchol 1.875 g (You will take a total of 12 capsules of Wechol 1.875g per day; taken as 6 capsules twice a day by mouth).

Other:
• Double Placebo
Double placebo twice per day (You 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).

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Entera Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for the study is a comparison among the three therapy groups of stool frequency during treatment period	Number of Daily bowel movements	30 days	No
Primary	The primary endpoint for the study is a comparison among the three therapy groups of stool consistency during treatment period	Stool consistency	30 days	No