RecruitingEarly Phase 1NCT05846880

VitD3 Supplementation in Patients With Multiple Myeloma

EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE

Sponsor

Amany Keruakous, MD, MS.

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether vitamin D3 supplementation can improve outcomes — including immune function and quality of life — in patients with multiple myeloma (a type of blood cancer) who are deficient in vitamin D. Many myeloma patients have low vitamin D, and this study aims to understand whether correcting that deficiency matters. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of multiple myeloma - You are in reasonably good health and able to carry out daily activities - You have low or deficient vitamin D levels - You are currently receiving treatment for myeloma or are being monitored **You may NOT be eligible if...** - You have high calcium levels in your blood - You have severe kidney disease - You are already taking high-dose vitamin D supplements - You have conditions that prevent you from absorbing vitamin D properly - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenalidomide

For first three cycles, taken orally once daily for 28 days at 10mg/day dose. After cycle 4, taken orally once daily at 15 mg/day dose

DRUGMaintenance Vitamin D

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, will start maintenance therapy with Monthly replacement with 50,000 IU

DRUGNo maintenance Vitamin D

After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels

Locations(1)

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

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NCT05846880

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