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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A: SBI + Placebo

Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams + placebo twice per day

Group Type ACTIVE_COMPARATOR

Serum-derived bovine immunoglobulin/protein isolate (SBI)

Intervention Type OTHER

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

Intervention Type OTHER

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).

Group B: Colesevelam + Placebo

Colesevelam 1.875 g + Placebo twice per day

Group Type ACTIVE_COMPARATOR

Colesevelam

Intervention Type DRUG

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).

Double Placebo

Intervention Type OTHER

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).

Group C: Colesevelam + SBI

Colesevelam 1.875 g + Serum-derived bovine immunoglobulin/protein isolate (SBI) 10 grams twice per day

Group Type ACTIVE_COMPARATOR

Serum-derived bovine immunoglobulin/protein isolate (SBI)

Intervention Type OTHER

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

Intervention Type DRUG

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).

Group D: Double Placebo

Double placebo twice per day

Group Type PLACEBO_COMPARATOR

Double Placebo

Intervention Type OTHER

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).

Interventions

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Serum-derived bovine immunoglobulin/protein isolate (SBI)

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)

Intervention Type OTHER

Colesevelam

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).

Intervention Type DRUG

Double Placebo

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).

Intervention Type OTHER

Other Intervention Names

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Welchol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No