Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT02619812
- Run by
- Mayo Clinic
- People needed
- 4
- Starts
- 2016-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-06-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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