VitD3 Supplementation in Patients With Multiple Myeloma

February 14, 2024 updated by: Amany Keruakous, MD, MS.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide + intensified VitD
In this arm, patients will receive the standard lenalidomide dose along with an intensified level of Vitamin D maintenance regimen.
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
Other Names:
  • Revlimid
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
Other Names:
  • Cholecalciferol
Active Comparator: Lenalidomide + therapeutic VitD
In this arm, patients will receive the standard lenalidomide dose along with a therapeutic level of Vitamin D regimen.
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
Other Names:
  • Revlimid
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
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]
Time Frame: 120 days
Evaluate absolute lymphocyte count and the difference in subset analysis (absolute CD4 count, absolute CD8 count) 120 days after ASCT
120 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To report the 3-year progression-free survival for both treatment arms - intensified vs. therapeutic Vitamin D supplementation
Time Frame: 3 years
3 years
To report the overall response rate for both treatment arms 120 days after ASCT for adult patients with multiple myeloma.
Time Frame: 120 Days
120 Days
To report the overall response rate for both treatment arms 2 years after transplantation
Time Frame: Two Years
Two Years
To report the 3-year overall survival for the two treatment arms after transplantation.
Time Frame: Three Years
Three Years
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.
Randomization; 120 days after transplantation; two years after 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
Time Frame: Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation
Before autologous stem cell transplant; 120 days after transplantation; three years post-transplantation
To describe the adverse events for the two treatment arms
Time Frame: Three years
Three years
To report time to neutrophil and platelet engraftment as well as transfusion independence after transplantation in both treatment arms
Time Frame: After transplantation, an average of 30 days
After transplantation, an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amany Keruakous, MD, MS.

Investigators

  • Principal Investigator: Amany Keruakous, MD, Georgia Cancer Center at Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCC-22-044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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