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Immunomodulatory Agent

Lenalidomide for Smoldering Multiple Myeloma

Phase 3

Waitlist Available

Led By Sagar Lonial

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have no prior or concurrent systemic or radiation therapy for the treatment of myeloma

Be older than 18 years old

Must not have

Patients must not have grade 2 or higher peripheral neuropathy

Patients with monoclonal gammopathy of undetermined significance are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares lenalidomide to observation in treating patients with asymptomatic high-risk multiple myeloma. It is not yet known whether lenalidomide is more effective than observation alone.

Who is the study for?

This trial is for patients with high-risk smoldering multiple myeloma who haven't had previous systemic or radiation therapy. They should have measurable M-protein levels and meet certain blood and biochemical standards. Women of childbearing age must follow strict pregnancy testing and contraception rules. HIV+ individuals can join if they meet additional criteria, but those with active infections, severe neuropathy, advanced heart failure, or immediate need for chemotherapy are excluded.

What is being tested?

The study is examining the effectiveness of lenalidomide compared to just watching and waiting in patients with asymptomatic high-risk smoldering multiple myeloma. It's a randomized trial where some people will receive the drug while others won't get any treatment unless their condition worsens.

What are the potential side effects?

Lenalidomide may cause side effects like fatigue, diarrhea, constipation, low blood counts leading to increased infection risk or bleeding problems, rash or itching skin. There might also be more serious risks like blood clots.

Eligibility Criteria

Inclusion Criteria

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

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I have not received any treatment for myeloma before.

Exclusion Criteria

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

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I do not have severe numbness or pain in my hands or feet.

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I do not have a condition known as monoclonal gammopathy of undetermined significance.

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I do not have any ongoing, untreated infections.

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My heart functions well enough for most activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)

Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)

Secondary study objectives

1-year Progression-free Survival (PFS) Rate (Phase III Secondary Endpoint)

2-year Overall Survival (OS) Rate (Phase III Secondary Endpoint)

2-year Progression-free Rate (Phase III Secondary Endpoint)

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