A Study to Evaluate Diarrhea in Patients with Multiple Myeloma Receiving Conditioning Chemotherapy for Autologous Stem Cell Transplantation (SCT)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009118
Sponsor Protocol Number: 16-009118
About this study
The purpose of this study is to evaluate the changes in bowel movements in patients with multiple myeloma receiving conditioning cheomotherapy for autologous stem cell transplantation (SCT).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥18 years, male or female
- Diagnosis: multiple myeloma undergoing Autologous Stem Cell Transplantation (SCT)
- Planning to receive conditioning chemotherapy with Melphalan (140 – 200 mg/m2) alone 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.
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
- Women who are pregnant or breast-feeding
- Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Camilleri, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available