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Immunomodulatory Agent
Melphalan + Prednisone + Thalidomide/Lenalidomide for Multiple Myeloma
Phase 3
Waitlist Available
Led By Alexander K Stewart
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 a confirmed diagnosis of symptomatic myeloma with specific criteria for bone marrow plasmacytosis or biopsy proven plasmacytoma
Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Awards & highlights
Study Summary
This trial compares melphalan/prednisone with thalidomide to melphalan/prednisone with lenalidomide to see which is more effective in treating newly diagnosed multiple myeloma.
Who is the study for?
This trial is for patients with newly diagnosed multiple myeloma. Eligible participants are those over 65 who declined alternative treatments, or adults under 65 not suitable for stem cell transplantation. They must have an ECOG performance status of <=2, no severe peripheral neuropathy, uncontrolled illnesses, active infections, or recent malignancies (with exceptions). Women of childbearing age must test negative for pregnancy and follow strict birth control measures.Check my eligibility
What is being tested?
The study compares two treatment combinations: melphalan and prednisone with thalidomide versus the same chemotherapy drugs with lenalidomide. The goal is to determine which combination better halts cancer growth by either killing cells or blocking blood flow to them. Participants will be randomly assigned to one of these treatment groups.See study design
What are the potential side effects?
Potential side effects include reactions from chemotherapy like nausea and hair loss; thalidomide may cause drowsiness or nerve damage; lenalidomide can lead to blood clots or fatigue. Both medications could increase the risk of birth defects if taken during pregnancy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with symptomatic myeloma confirmed by bone marrow or biopsy tests.
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I started treatment because my symptoms were affecting my organs when I was first diagnosed.
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I can take care of myself but might not be able to do heavy physical work.
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I am able to have children, not pregnant, and agree to use birth control.
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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 any ongoing, untreated infections.
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I am willing to take aspirin or another blood thinner as directed.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
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 (PFS)
Secondary outcome measures
Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
Overall Survival
Very Good Partial Response (VGPR) Rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (lenalidomide)Experimental Treatment4 Interventions
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.
Group II: Arm I (thalidomide)Active Control5 Interventions
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Lenalidomide
2005
Completed Phase 3
~1480
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,847 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,424 Patients Enrolled for Multiple Myeloma
Alexander K StewartPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have myeloma and haven't been treated for it, except for short-term specific medications.I am willing to use a condom during and after treatment as required.I do not have smoldering myeloma or MGUS without symptoms.I am over 65 and have declined other treatments, or I am 18-64, cannot have a stem cell transplant, or have declined it.I do not have any severe illnesses that would stop me from following the study's requirements.I have been diagnosed with symptomatic myeloma confirmed by bone marrow or biopsy tests.I started treatment because my symptoms were affecting my organs when I was first diagnosed.I can take care of myself but might not be able to do heavy physical work.I am able to have children, not pregnant, and agree to use birth control.I haven't been treated for another cancer besides this one in the last 2 years.You have had Stevens Johnson syndrome before.I do not have severe numbness or pain in my hands or feet.I am taking bisphosphonates or erythropoietin for my multiple myeloma.I do not have any ongoing, untreated infections.I am willing to take aspirin or another blood thinner as directed.I am not pregnant or breastfeeding.I do not have any severe illnesses that would stop me from following the study's requirements.All my required tests were done within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (thalidomide)
- Group 2: Arm II (lenalidomide)
Awards:
This trial has 2 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has lenalidomide been cleared for use by the FDA?
"Lenalidomide's safety is well supported by clinical data, and thus it received a score of 3."
Answered by AI
Could you provide a ballpark number of the hospitals testing this new treatment?
"100 different medical facilities are hosting this clinical trial, for example Porter Adventist Hospital in Denver, Syracuse Veterans Administration Medical Center in Syracuse, and Saint Joseph's Hospital - Healtheast in Saint Paul."
Answered by AI
Does Lenalidomide boast a long and effective history?
"Lenalidomide was first studied in 2001 at Hulston Cancer Center. So far, 1974 clinical trials have been completed with 713 more currently active. A majority of these studies are based out of Denver, Colorado."
Answered by AI
How many participants are in this trial?
"The clinical trial was last updated on September 23rd, 2022 and is not presently looking for patients. However, there are 838 other trials for multiple myeloma and 713 trials involving Lenalidomide that are actively recruiting participants."
Answered by AI
Are there any current vacancies for participants in this trial?
"Unfortunately, this trial is no longer recruiting patients according to the latest information on clinicaltrials.gov. The study was initially posted on 2/29/2008 and updated for the last time on 9/23/2022. However, there are still 1551 other trials that need participants right now."
Answered by AI
For what medical reasons is Lenalidomide most often prescribed?
"Lenalidomide can be used to treat ophthalmia, sympathetic, scalp structure, and at least two prior systemic chemotherapy regiments."
Answered by AI
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