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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
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
After replacement of vitamin D deficiency with weekly cholecalcefirol 50,000 units untill levels are \> 30, stop replacement and continue monitoring levels
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
RECRUITINGTo describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
Time frame: 120 days
3 year progression free survival
To report the 3-year progression-free survival for both treatment arms - maintenance Vitamin D vs. No maintnenace Vitamin D supplementation
Time frame: 3 years
Overall Response Rate post 120 days of ASCT
report the overall response rate for both treatment arms 120 days after ASCT for adult patients with multiple myeloma.
Time frame: 120 Days
Overall Response Rate after transplantation
To report the overall response rate for both treatment arms 2 years after transplantation
Time frame: Two Years
3 Year Overall Survival after transplantation
To report the 3-year overall survival for the two treatment arms after transplantation.
Time frame: Three Years
Minimal Residual Disease status
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.
Time frame: Randomization; 120 days after transplantation; two years after transplantation.
Vitamin D levels
To report the vitamin D levels between the two treatments arms before autologous stem cell transplant, within 120 days, and 3-years post-transplantation
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Time frame: Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation
Adverse Event Reporting
To describe the adverse events for the two treatment arms
Time frame: Three years
Neutrophil and Platelet Engraftment and Transfusion Independence
Time to neutrophil and platelet engraftment as well as transfusion independence after transplantation
Time frame: After transplantation, an average of 30 days