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Lenalidomide Maintenance for Multiple Myeloma

Phase 2

Waitlist Available

Led By Alexander Lesokhin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with plasma cell myeloma treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to International Myeloma Workshop Consensus Panel

Men must agree to use a latex condom during sexual contact with a female of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether maintenance therapy can help keep myeloma from coming back in patients who have already been treated and are in remission.

Who is the study for?

This trial is for adults over 18 with plasma cell myeloma who've had prior treatment and are now stable or better. They must practice birth control, have good organ function, agree to a REMS program for drug safety, and take daily blood clot prevention meds. It's not for those with active hepatitis B/C, HIV, recent heart attacks or other cancers within 3 years, pregnant/breastfeeding women, or severe reactions to similar drugs.Check my eligibility

What is being tested?

The study tests Lenalidomide as a maintenance therapy in patients whose myeloma has been treated and is currently under control. The aim is to understand the benefits and risks of using this drug long-term after initial cancer treatment.See study design

What are the potential side effects?

Lenalidomide may cause blood clots which is why anticoagulants are required during the trial. Other side effects can include fatigue, diarrhea, rash or itching; it might also affect white blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My myeloma is stable or better after initial treatment.

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I agree to use a condom during sex if my partner can get pregnant.

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I can take daily medication to prevent blood clots.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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I am not pregnant and will use birth control during the trial.

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I am registered and can follow the Revlimid REMS program requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

progression-free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: LenalidomideExperimental Treatment1 Intervention

Subjects will receive lenalidomide 10 mg by mouth daily on days 1-21 of a 28-day cycle. Subjects may continue lenalidomide until disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or the end of the study (5 years); whatever comes first. Patients who complete at least four cycles of treatment will be considered evaluable.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,514 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,059 Patients Enrolled for Multiple Myeloma

Alexander Lesokhin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

7 Total Patients Enrolled

1 Trials studying Multiple Myeloma

7 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide Clinical Trial Eligibility Overview. Trial Name: NCT02538198 — Phase 2

Multiple Myeloma Research Study Groups: Lenalidomide

Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT02538198 — Phase 2

Lenalidomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT02538198 — Phase 2

Frequently Asked Questions

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

In what instances is Lenalidomide typically prescribed?

"Lenalidomide is typically utilized to treat multiple myeloma, but can potentially benefit patients with relapsed/refractory lymphomas and chronic lymphocytic leukemia that have experienced two prior systemic chemotherapies."

Answered by AI

Has Lenalidomide obtained clearance from the FDA?

"Based on the information available, Lenalidomide is likely to be of medium safety as Phase 2 trials indicate that there are only some data supporting its safety but not efficacy."

Answered by AI

Are there any available slots for individuals to participate in this experimentation?

"Unfortunately, this research project is not recruiting at the moment. It was originally instituted August 31st 2015 and has recently been updated September 1st 2022. However, there are 818 other trials looking for participants with neoplasms or plasma cell disorders as well as 267 studies that involve lenalidomide actively enlisting volunteers."

Answered by AI

How many sites are overseeing this evaluation?

"Currently, 6 sites are open to participants. These include spots in New york and Uniondale plus Commack among others. Prospective enrollees should select the closest location possible so as to avoid unnecessary travel demands if they choose to join this trial."

Answered by AI

Are there any additional investigations of Lenalidomide's efficacy?

"Lenalidomide was first researched in 2004 at Midwest Center for Hematology Oncology with 346 studies since completed. Currently, 267 ongoing clinical trials are underway and many of these experiments are hosted in New york City."

Answered by AI

How many volunteers have signed up for the research project?

"Sadly, recruitment is no longer possible for this particular trial as the last update occurred on September 1st of 2022. However, 818 trials are currently looking to enrol neoplasm and plasma cell participants while 267 other studies are seeking individuals who wish to treat their condition with lenalidomide."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Dynamics of Minimal Residual Disease in Patients with Multiple Myeloma on Continuous Lenalidomide Maintenance: A Single-arm, Single-centre, Phase 2 Trial

Diamond, Benjamin, Neha Korde, Alexander M Lesokhin, Eric L Smith, Urvi Shah, Sham Mailankody, Malin Hultcrantz, et al.. 2021. “Dynamics of Minimal Residual Disease in Patients with Multiple Myeloma on Continuous Lenalidomide Maintenance: A Single-arm, Single-centre, Phase 2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00130-7.

clinicaltrials.govStudy

Lenalidomide Maintenance in Plasma Cell Myeloma

2015. "Lenalidomide Maintenance in Plasma Cell Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02538198.

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