VitD3 Supplementation in Patients With Multiple Myeloma VITAMIN D

What's the purpose of this trial?

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. 

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Diagnosis of multiple myeloma without amyloidosis.
* Willing and able to take medication to prevent blood clots (example: aspirin, low molecular weight heparin, etc.) and comply with lenalidomide REMS program requirements.
* 18 years or older.
* Eligible for autologous stem cell transplantation or have completed ASCT within 120 days prior to starting the study.
* Be able to take and swallow oral medication (capsules) whole with no impairment of gastrointestinal function.

Exclusion Criteria:

* Prior transplant (solid organ or stem cell)
* Known allergy to study drug (cholecalciferol)
* Other prior cancer diagnosis

Additional Trial Information

Phase 1

Enrollment: 100 patients (estimated)

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Trial Locations

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Georgia

Augusta University Medical Center

Augusta, GA

Not Yet Accepting
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