- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619812
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a randomized, double-blind, placebo-controlled pilot study of SBI, colesevelam, and placebo in patients undergoing autologous HSCT for the clinical care of multiple myeloma.
The number of adults undergoing hematopoietic stem cell transplant (HSCT) has grown significantly over the past two decades as a result of the availability of therapies for advanced hematologic and solid tumor malignancies, and the broader selection criteria for eligibility to receive these transplants. Generally, the stem cell transplant procedure consists of administration of chemotherapy and/or radiation therapy to ablate all residual malignancy (called conditioning therapy), followed by intravenous infusion of hematopoietic stem cells to restore bone marrow function. Generally, HSCT has a positive effect on survival, despite serious adverse effects and life-threatening complications.
Diarrhea can affect up to 91% of patients receiving autologous or allogeneic HSCT and is identified by 9% of the patients as the single most debilitating adverse effect post-HSCT. Other commonly encountered symptoms are nausea and vomiting (13%) and mouth sores (42%). The impact of diarrhea can be significant and result in dehydration, negative impact on quality of life, prolonged hospitalization with an increased cost and risk, and the diarrhea may be potentially life-threatening.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A: SBI + Placebo
Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
|
SBI 10 grams (The subject will take a total of 4 packets of SBI; taken as two packets of SBI twice a day mixed with water or blended with certain foods)
Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
Active Comparator: Group B: Colesevelam + Placebo
Colesevelam 1.875 g + Placebo twice per day
|
Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
Colesevelam 1.875 g (The subject will take a total of 12 capsules of Welchol 1.875g per day; taken as 6 capsules twice a day by mouth).
Other Names:
|
Active Comparator: Group C: Colesevelam + SBI
Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day
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SBI 10 grams (The subject will take a total of 4 packets of SBI; taken as two packets of SBI twice a day mixed with water or blended with certain foods)
Colesevelam 1.875 g (The subject will take a total of 12 capsules of Welchol 1.875g per day; taken as 6 capsules twice a day by mouth).
Other Names:
|
Placebo Comparator: Group D: Double Placebo
Double placebo twice per day
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Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool Frequency
Time Frame: 30 days
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Stool frequency was self reported in a daily bowel pattern diary for 30 days.
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30 days
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Stool Consistency
Time Frame: 30 days
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The subjects rated their stool consistency using the Bristol Stool Scale.
The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types.
Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.
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30 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Signs and Symptoms, Digestive
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Diarrhea
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Immunologic Factors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- Colesevelam Hydrochloride
Other Study ID Numbers
- 15-006205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Cedars-Sinai Medical CenterEntera Health, IncCompletedUse of SBI in IBS Subjects Following a Successful Treatment of Small Intestinal Bacterial OvergrowthSmall Intestinal Bacterial Overgrowth | Diarrhea Predominant Irritable Bowel SyndromeUnited States
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Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingFemale Reproductive CancerUnited States
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Entera Health, IncCompletedHIV-associated EnteropathyUnited States
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Mayo ClinicCompletedDiarrhea-predominant Irritable Bowel SyndromeUnited States
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Northwestern UniversityEntera Health, IncTerminatedClostridium DifficileUnited States
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Entera Health, IncCompleted
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Entera Health, IncCompletedDiarrhoea Predominant Irritable Bowel SyndromeUnited States
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St. Louis UniversityAmerican College of Gastroenterology; Entera Health, IncCompletedAscites | Spontaneous Bacterial Peritonitis | Cirrhosis of the LiverUnited States
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Connecticut Children's Medical CenterCompletedDiarrhea Predominant Irritable Bowel SyndromeUnited States