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Corticosteroid
Lenalidomide + Dexamethasone +/- Thalidomide for Multiple Myeloma
Phase 3
Waitlist Available
Led By S. V Rajkumar
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
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Must have specified renal and hepatic function within defined limits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 4 weeks for 16 weeks during step 1
Awards & highlights
Study Summary
This trial is testing lenalidomide and dexamethasone with or without thalidomide to treat multiple myeloma.
Who is the study for?
This trial is for adults recently diagnosed with symptomatic multiple myeloma. They should have certain blood and marrow conditions, not be pregnant or breastfeeding, and can't have had previous systemic therapy for the disease (except bisphosphonates). People with severe illnesses, uncontrolled infections, a history of blood clots without anticoagulation therapy, or significant neuropathy cannot join.Check my eligibility
What is being tested?
The study compares lenalidomide combined with low or standard doses of dexamethasone against the same regimen plus thalidomide in treating multiple myeloma. It aims to see which combination is more effective at stopping cancer growth by affecting the immune system and cutting off cancer's blood supply.See study design
What are the potential side effects?
Potential side effects include risk of infection, blood clots, nerve damage (neuropathy), fatigue, constipation, rash and may affect liver function. Thalidomide specifically can cause birth defects; hence strict contraception measures are required.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
Select...
My kidney and liver functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed every 4 weeks for 16 weeks during step 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 4 weeks for 16 weeks during step 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Patients With Objective Response (First Phase, Step 1)
Secondary outcome measures
Proportion of Patients With Objective Response (First Phase, Step 2)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (thalidomide, low-dose dexamethasone)Experimental Treatment3 Interventions
Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Group II: Arm II (lenalidomide, low-dose dexamethasone)Experimental Treatment3 Interventions
Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Group III: Arm III (thalidomide, dexamethasone)Active Control3 Interventions
Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Group IV: Arm I (lenalidomide, dexamethasone)Active Control3 Interventions
Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Thalidomide
2001
Completed Phase 4
~3050
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,701 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,278 Patients Enrolled for Multiple Myeloma
S. V RajkumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Arm IV (thalidomide, low-dose dexamethasone)
- Group 2: Arm II (lenalidomide, low-dose dexamethasone)
- Group 3: Arm III (thalidomide, dexamethasone)
- Group 4: Arm I (lenalidomide, dexamethasone)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there different research institutions conducting this trial in different states?
"There are over one-hundred locations where this study is accepting patients, some of which include Montana Cancer Consortium NCORP in Billings, Montana, Ascension Alexian Brothers - Elk Grove Village in Elk Grove Village, Illinois, and Franciscan Health Indianapolis in Indianapolis, Indiana."
Answered by AI
Could you list any other times Lenalidomide has been tested in a clinical setting?
"In 2002, the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba first studied lenalidomide. Since the initial study, there have been a total of 1960 completed studies. Right now, there are 736 active trials, with a large concentration in Billings, Montana."
Answered by AI
Has the FDA cleared Lenalidomide for therapeutic use?
"Lenalidomide is considered safe according to our team's 3-point scale. This is due to the fact that Lenalidomide has undergone multiple Phase 3 trials, providing support for both its efficacy and safety."
Answered by AI
What are some common treatments that Lenalidomide is used for?
"Lenalidomide has been approved by the FDA to treat ophthalmia, sympathetic. Additionally, it can be used off-label to treat branch retinal vein occlusion, and macular edema in patients that have failed at least two prior systemic chemotherapy regimens."
Answered by AI
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