Multiple Myeloma Clinical Trial
Official title:
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)
To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.
This is 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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