TerminatedPhase 2

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

Stopped: Difficulty recruiting; pill burden and nausea were barriers

United States4 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Stool Frequency

Timeframe: 30 days

Stool Consistency

Timeframe: 30 days

Trial details

NCT IDNCT02619812

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2017-01-27