VitD3 Supplementation in Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05846880
- Lead Sponsor
- Amany Keruakous, MD, MS.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- Prior transplant (solid organ or stem cell)
- Known allergy to study drug (cholecalciferol)
- Other prior cancer diagnosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maintenance Vitamin D Lenalidomide In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D. Maintenance Vitamin D Maintenance Vitamin D In this arm, patients will receive maintenance Vitamin D3 prior to autologous transplantation (ASCT). Within 120 days after ASCT the following will be assessed: vitamin D level, Overall Response Rate (ORR) and Measurable Residual Disease (MRD). Then patients will receive lenalidomide and continuation of maintenance Vitamin D. No Maintenance Vitamin D Lenalidomide In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D. No Maintenance Vitamin D No maintenance Vitamin D In this arm, patients will receive no maintenance vitamin D prior to ASCT. Within 120 days after ASCT the following will be assessed: vitamin D level, ORR, and MRD. Then patients will receive the standard lenalidomide dose along with no maintenance vitamin D.
- Primary Outcome Measures
Name Time Method To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days] 120 days Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
- Secondary Outcome Measures
Name Time Method 3 year progression free survival 3 years To report the 3-year progression-free survival for both treatment arms - maintenance Vitamin D vs. No maintnenace Vitamin D supplementation
Overall Response Rate post 120 days of ASCT 120 Days report the overall response rate for both treatment arms 120 days after ASCT for adult patients with multiple myeloma.
Overall Response Rate after transplantation Two Years To report the overall response rate for both treatment arms 2 years after transplantation
3 Year Overall Survival after transplantation Three Years To report the 3-year overall survival for the two treatment arms after transplantation.
Minimal Residual Disease status Randomization; 120 days after transplantation; two years after transplantation. To report the minimal residual disease status for the two treatment arms at randomization, and within 120 days after transplantation and 2 years after transplantation.
Vitamin D levels Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation To report the vitamin D levels between the two treatments arms before autologous stem cell transplant, within 120 days, and 3-years post-transplantation
Adverse Event Reporting Three years To describe the adverse events for the two treatment arms
Neutrophil and Platelet Engraftment and Transfusion Independence After transplantation, an average of 30 days Time to neutrophil and platelet engraftment as well as transfusion independence after transplantation
Trial Locations
- Locations (1)
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States