VitD3 Supplementation in Patients With Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05846880
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amany Keruakous, MD, MS.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amany Keruakous, MD
Principal Investigator Affiliation	Georgia Cancer Center at Augusta University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Lenalidomide + intensified VitD

In this arm, patients will receive the standard lenalidomide dose along with an intensified level of Vitamin D maintenance regimen.

Active Comparator: Lenalidomide + therapeutic VitD

In this arm, patients will receive the standard lenalidomide dose along with a therapeutic level of Vitamin D regimen.

Interventions

Drug: - Lenalidomide

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

Drug: - Vitamin D - Intensified

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

Drug: - Vitamin D - Therapeutic

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Augusta, Georgia

Status

Address

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912

Site Contact

Kelly Jenkins, MSN, RN

kejenkins@augusta.edu

706-721-1206

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