VitD3 Supplementation in Patients With Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amany Keruakous, MD, MS.
• Treatments: Cholecalciferol; Ergocalciferols; Lenalidomide; Vitamin D; Vitamins

Criteria

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