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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

Must not have

Prior organ transplant requiring immunosuppressive therapy

Plasma cell leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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.

Exclusion Criteria

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

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I have had an organ transplant and am on immunosuppressive drugs.

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I have been diagnosed with plasma cell leukemia.

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My blood pressure or diabetes is not well-managed.

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I have had a stem cell transplant from a donor.

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I do not have any conditions that affect drug absorption.

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I do not have any uncontrolled illnesses.

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I have not had major surgery in the last month.

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I had a severe reaction to thalidomide or lenalidomide.

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My plasma cell myeloma is not responding to treatment or is getting worse.

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I am on constant medication to suppress my immune system.

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I do not have severe nerve pain or damage.

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I cannot take blood thinners due to health reasons.

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My condition did not improve with my last lenalidomide treatment.

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

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

Primary study objectives

progression-free survival

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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 / 20Eligibility criteria met