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Immunomodulatory Agent

Lenalidomide for Smoldering Multiple Myeloma

Q: Are there historical examples of Lenalidomide's effectiveness?

<a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> was first trialled in 2004 at Ascension Alexian Brothers - Elk Grove Village. In the 16 years since, there have been 347 completed trials. At the moment, there are 272 trials actively recruiting patients, with a large portion of these studies based in Dayton, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Q: How many individuals are receiving care as part of this research project?

Unfortunately, this trial is no longer actively recruiting patients. The study was first posted on 2011-01-24 and had its last update on 2021-04-29. For individuals still interested in participating in research, there are 828 studies currently searching for patients with smoldering <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a> and 272 trials for <a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> that are actively looking for participants.

Q: In how many areas is this research being conducted?

One hundred medical facilities are currently running this study. In addition to Dayton, Sunset Hills and Portland, the other participating 100 cities are also conducting this research. If you enroll, try to choose a location that is close to you to limit travel.

Q: What are the primary benefits of Lenalidomide?

<a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> is most often given to patients with <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>. However, it has also been shown to help those struggling with relapsed and/or refractory <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, <a href="https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia">chronic lymphocytic leukemia</a>, and who have undergone at least two different systemic chemotherapy regimens.

Q: Can people with the specified medical condition join this clinical trial at this time?

This study is not currently recruiting participants anymore. The clinical trial was first posted on 2011-01-24 and was last updated on 2021-04-29. If you are searching for for other studies, there are currently 828 clinical trials actively admitting participants with smoldering <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a> and 272 studies for <a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> actively enrolling participants.

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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I have not received any treatment for myeloma before.

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

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

Primary outcome measures

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 outcome measures

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)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (lenalidomide)Experimental Treatment2 Interventions

Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (observation)Active Control2 Interventions

Patients undergo observation until progression to symptomatic myeloma.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,927 Total Patients Enrolled

578 Trials studying Multiple Myeloma

188,504 Patients Enrolled for Multiple Myeloma

Sagar LonialPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

8 Total Patients Enrolled

1 Trials studying Multiple Myeloma

8 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01169337 — Phase 3

Multiple Myeloma Research Study Groups: Arm A (lenalidomide), Arm B (observation)

Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01169337 — Phase 3

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01169337 — Phase 3

Frequently Asked Questions

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

Are there historical examples of Lenalidomide's effectiveness?

"Lenalidomide was first trialled in 2004 at Ascension Alexian Brothers - Elk Grove Village. In the 16 years since, there have been 347 completed trials. At the moment, there are 272 trials actively recruiting patients, with a large portion of these studies based in Dayton, Ohio."

Answered by AI

How many individuals are receiving care as part of this research project?

"Unfortunately, this trial is no longer actively recruiting patients. The study was first posted on 2011-01-24 and had its last update on 2021-04-29. For individuals still interested in participating in research, there are 828 studies currently searching for patients with smoldering multiple myeloma and 272 trials for Lenalidomide that are actively looking for participants."

Answered by AI

In how many areas is this research being conducted?

"One hundred medical facilities are currently running this study. In addition to Dayton, Sunset Hills and Portland, the other participating 100 cities are also conducting this research. If you enroll, try to choose a location that is close to you to limit travel."

Answered by AI

What are the primary benefits of Lenalidomide?

"Lenalidomide is most often given to patients with multiple myeloma. However, it has also been shown to help those struggling with relapsed and/or refractory lymphoma, chronic lymphocytic leukemia, and who have undergone at least two different systemic chemotherapy regimens."

Answered by AI

Can people with the specified medical condition join this clinical trial at this time?

"This study is not currently recruiting participants anymore. The clinical trial was first posted on 2011-01-24 and was last updated on 2021-04-29. If you are searching for for other studies, there are currently 828 clinical trials actively admitting participants with smoldering multiple myeloma and 272 studies for Lenalidomide actively enrolling participants."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma

Lonial, Sagar, Susanna Jacobus, Rafael Fonseca, Matthias Weiss, Shaji Kumar, Robert Z. Orlowski, Jonathan L. Kaufman, et al.. 2020. “Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.01740.

clinicaltrials.govStudy

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

2011. "Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01169337.

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