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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 belowSelect...
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:Select...
I do not have severe numbness or pain in my hands or feet.
Select...
I do not have a condition known as monoclonal gammopathy of undetermined significance.
Select...
I do not have any ongoing, untreated infections.
Select...
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
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)
+2 moreAwards & Highlights
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,879 Previous Clinical Trials
41,013,020 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,129 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not urgently need chemotherapy.I do not have a condition known as monoclonal gammopathy of undetermined significance.You must have a detectable amount of M-protein in your blood.I am HIV positive and meet the specific health criteria.I meet the medication and medical history requirements.I was diagnosed with a high-risk type of early-stage multiple myeloma within the last 5 years.I do not have severe numbness or pain in my hands or feet.I am following the required pregnancy prevention measures.I have not received any treatment for myeloma before.I do not have any ongoing, untreated infections.I do not have any excluded medical conditions.My heart functions well enough for most activities.I had cancer before but meet specific criteria for this trial.Patients must have certain blood and body chemistry levels within a specific range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (lenalidomide)
- Group 2: Arm B (observation)
Awards:
This trial has 4 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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