Clinical Trials Logo

Clinical Trial Summary

This trial investigates the effect of fermented milk supplementation on symptoms of disease and treatment in patients with multiple myeloma. Patients with multiple myeloma may experience symptoms related to the disease and/or treatment that affect quality of life. Supplementing usual diet with a probiotic fermented milk product called kefir may contribute to reducing disease and treatment-related side effects through changing the intestinal bacteria community structure and related metabolism.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Determine the effect of a 3-month randomized dietary intervention with a probiotic kefir beverage in multiple myeloma (MM) patients on biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and quality of life (QoL). SECONDARY OBJECTIVE: I. Determine the effect of kefir supplementation on gut microbial phylotype and predicted bacterial metabolic function, and assess associations with biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and QoL. EXPLORATORY OBJECTIVE: I. Feasibility of a probiotic lifestyle intervention in MM patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients consume commercial kefir beverage daily for 3 months. ARM II: Patients maintain usual diet for 3 months. After completion of study, patients are followed up at 30 days or until resolution of any study related toxicity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04530812
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase N/A
Start date August 24, 2020
Completion date August 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT02513186 - Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Recruiting NCT05497804 - Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial Phase 2
Completed NCT02880228 - Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant Phase 2
Recruiting NCT04782687 - Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma Phase 2
Completed NCT02514668 - A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma Phase 1
Active, not recruiting NCT03417284 - Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation Phase 1/Phase 2
Active, not recruiting NCT05142371 - Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Active, not recruiting NCT03275285 - Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients Phase 3
Completed NCT04100044 - Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma N/A
Active, not recruiting NCT00075478 - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 3
Recruiting NCT05561387 - Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment Phase 3
Completed NCT03317899 - Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma Phase 2
Active, not recruiting NCT05511428 - Home Based Daratumumab Administration for Patients With Multiple Myeloma Early Phase 1
Completed NCT01919619 - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies Phase 2
Terminated NCT02353572 - Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Recruiting NCT04537871 - Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study