VitD3 Supplementation in Patients With Multiple Myeloma

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate post-transplant immune reconstitution and lymphocyte recovery as well as the 3-year progression-free survival of patients with multiple myeloma in two treatment arms. One arm will receive lenalidomide and an intensified regimen of maintenance VitD, and the other arm will receive lenalidomide and a therapeutic regimen of VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms.

Clinical Trial Description

Management of multiple myeloma (MM) has changed significantly over the past 10 years. The use of three drug induction therapy followed by autologous stem cell transplantation (ASCT) has become standard of care for transplant eligible patients with MM since randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with three drugs, albeit in the non-transplant setting. Evidence suggests Vitamin D deficiency is correlated with poorer outcomes in this population; however, it is unknown if intensified Vitamin D supplementation improves outcomes. This clinical trial aims to address this question and will postulate the impact of Vitamin D on immunoregulatory functions and the hematopoietic niche microenvironment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05846880
Study type	Interventional
Source	Augusta University
Contact	Kelly Jenkins, MSN, RN
Phone	706-721-1206
Email	kejenkins@augusta.edu
Status	Not yet recruiting
Phase	Early Phase 1
Start date	April 2024
Completion date	May 2028

View Details

See also
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