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. 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.

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

What will happen during the trial?

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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