Clinical trial · Interventional
Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty recruiting; pill burden and nausea were barriers
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colesevelam | Drug | — | UNRESOLVED |
| Double Placebo | Other | — | UNRESOLVED |
| Serum-derived bovine immunoglobulin/protein isolate (SBI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Group A: SBI + Placebo
- description
- Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
- interventionNames
- Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
- Other: Double Placebo
- type
- ACTIVE_COMPARATOR
- label
- Group B: Colesevelam + Placebo
- description
- Colesevelam 1.875 g + Placebo twice per day
- interventionNames
- Drug: Colesevelam
- Other: Double Placebo
- type
- ACTIVE_COMPARATOR
- label
- Group C: Colesevelam + SBI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available