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Immunomodulatory Agent

Vitamin D + Lenalidomide for Multiple Myeloma

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

Must not have

Other prior cancer diagnosis

Prior transplant (solid organ or stem cell)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with another type of cancer before.

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I have had a previous organ or stem cell transplant.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

3 Year Overall Survival after transplantation

3 year progression free survival

Adverse Event Reporting

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

0 / 7Eligibility criteria met