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Group C: Colesevelam + SBI for Multiple Myeloma

Phase 2
Waitlist Available
Led By Michael Camilleri, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stool Consistency
Stool Frequency

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Group B: Colesevelam + PlaceboActive Control2 Interventions
Colesevelam 1.875 g + Placebo twice per day
Group II: Group C: Colesevelam + SBIActive Control2 Interventions
Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day
Group III: Group A: SBI + PlaceboActive Control2 Interventions
Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
Group IV: Group D: Double PlaceboPlacebo Group1 Intervention
Double placebo twice per day

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,141 Total Patients Enrolled
80 Trials studying Multiple Myeloma
10,413 Patients Enrolled for Multiple Myeloma
Entera Health, IncIndustry Sponsor
11 Previous Clinical Trials
578 Total Patients Enrolled
Michael Camilleri, MDPrincipal InvestigatorMayo Clinic
38 Previous Clinical Trials
3,268 Total Patients Enrolled
~0 spots leftby Nov 2025
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