Vitamin D + Lenalidomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byAmany Keruakous, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Amany Keruakous, MD, MS.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amany Keruakous, MD

Principal Investigator

Georgia Cancer Center at Augusta University

Eligibility Criteria

This trial is for adults with multiple myeloma who can take blood clot prevention meds and comply with specific program requirements. They must be eligible for or have completed a stem cell transplant within the last 120 days, able to swallow pills, and not have other cancers or known allergies to Vitamin D supplements.

Inclusion Criteria

I have been diagnosed with multiple myeloma and do not have amyloidosis.

I can swallow pills without any issues.

I am willing to take blood clot prevention medication and follow the lenalidomide program.

See 2 more

Exclusion Criteria

I have been diagnosed with another type of cancer before.

I have had a previous organ or stem cell transplant.

I am allergic to the study drug (Vitamin D3).

Treatment Details

Interventions

Lenalidomide (Immunomodulatory Agent)
Vitamin D - Intensified (Vitamin Supplement)
Vitamin D - Therapeutic (Vitamin Supplement)

Trial OverviewThe study compares two groups: one taking lenalidomide with high-dose Vitamin D (intensified regimen) and another taking lenalidomide with standard-dose Vitamin D (therapeutic regimen). It aims to see how these affect immune recovery post-transplant and survival without disease progression over three years.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Maintenance Vitamin DExperimental Treatment2 Interventions

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.

Group II: No Maintenance Vitamin DActive Control2 Interventions

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.