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Immunomodulatory Agent

Vitamin D + Lenalidomide for Multiple Myeloma

Q: Does this research endeavor have any current openings for participants?

<p>As documented on clinicaltrials.gov, this medical investigation is no longer recruiting patients; it was initially posted on May 1st 2023 and edited for the last time on April 26th 2023. Nevertheless, there are 816 other trials that have open enrollment at present.</p>

Phase < 1

Waitlist Available

Led By Amany Keruakous, MD

Research Sponsored by Amany Keruakous, MD, MS.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of multiple myeloma without amyloidosis

Be able to take and swallow oral medication (capsules) whole with no impairment of gastrointestinal function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

Study Summary

This trial will compare two treatments for multiple myeloma, evaluating the progression-free survival, overall response rate, and survival.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Possible side effects include those from Lenalidomide such as diarrhea, itching, rash, tiredness; plus potential issues from high doses of Vitamin D like nausea, constipation, weakness or more serious ones like kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can swallow pills without any issues.

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To describe the lymphocyte subset analysis for the two treatment arms at 120 days post autologous stem cell transplant [120 days]

Secondary outcome measures

To describe the adverse events for the two treatment arms

To report the 3-year overall survival for the two treatment arms after transplantation.

To report the 3-year progression-free survival for both treatment arms - intensified vs. therapeutic Vitamin D supplementation

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lenalidomide + intensified VitDExperimental Treatment2 Interventions

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

Group II: Lenalidomide + therapeutic VitDActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Amany Keruakous, MD, MS.Lead Sponsor

Amany Keruakous, MDPrincipal InvestigatorGeorgia Cancer Center at Augusta University

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05846880 — Phase < 1

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05846880 — Phase < 1

Multiple Myeloma Research Study Groups: Lenalidomide + intensified VitD, Lenalidomide + therapeutic VitD

Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT05846880 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have any current openings for participants?

"As documented on clinicaltrials.gov, this medical investigation is no longer recruiting patients; it was initially posted on May 1st 2023 and edited for the last time on April 26th 2023. Nevertheless, there are 816 other trials that have open enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VitD3 Supplementation in Patients With Multiple Myeloma

Amany Keruakous, MD, MS. 2024. "VitD3 Supplementation in Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05846880.