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NCT02619812 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-06-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Stool Frequency

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outcome · POSTED

Stool Consistency

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day
    intervention Names
    1. Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
    2. Other: Double Placebo
    label
    Group A: SBI + Placebo
    type
    ACTIVE_COMPARATOR
  2. description
    Colesevelam 1.875 g + Placebo twice per day
    intervention Names
    1. Drug: Colesevelam
    2. Other: Double Placebo
    label
    Group B: Colesevelam + Placebo
    type
    ACTIVE_COMPARATOR
  3. description
    Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day
    intervention Names
    1. Other: Serum-derived bovine immunoglobulin/protein isolate (SBI)
    2. Drug: Colesevelam
    label
    Group C: Colesevelam + SBI
    type
    ACTIVE_COMPARATOR
  4. description
    Double placebo twice per day
    intervention Names
    1. Other: Double Placebo
    label
    Group D: Double Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Group A: SBI + Placebo
    2. Group C: Colesevelam + SBI
    description
    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)
    name
    Serum-derived bovine immunoglobulin/protein isolate (SBI)
    type
    OTHER
  2. arm Group Labels
    1. Group B: Colesevelam + Placebo
    2. Group C: Colesevelam + SBI
    description
    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).
    name
    Colesevelam
    other Names
    1. Welchol
    type
    DRUG
  3. arm Group Labels
    1. Group A: SBI + Placebo
    2. Group B: Colesevelam + Placebo
    3. Group D: Double Placebo
    description
    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).
    name
    Double Placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
4
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Stool frequency was self reported in a daily bowel pattern diary for 30 days.
    measure
    Stool Frequency
    time Frame
    30 days
  2. description
    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.
    measure
    Stool Consistency
    time Frame
    30 days
Full study description
brief 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.
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.
Source references
Source notices and limitations
    Discovery and provenance
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      true
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      occurrences
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      793598f6c2a098ab5c2759f4316d7a14e4a7ecea7c64d7775813f56b7e2b5752

    Preserved source evidence · Not medical advice