VitD3 Supplementation in Patients With Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT05846880
Trial Phases:		Protocol IDs:	GCC-22-044 (primary)
Eligibility:	, Male and Female	Study Type:
Study Sponsor:	Augusta University
NCI Full Details:	https://clinicaltrials.gov/study/NCT05846880

Summary

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.

Objectives

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 Maintenance Vitamin D and the other arm will receive no maintenance Vitamin D prior to ASCT. Post ASCT arm 1 will have lenalidomide and maintenance VitD, and arm 2 will receive lenalidomide and no maintenance VitD. This clinical trial will also evaluate the overall response rate and survival for both treatment arms

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.