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Immunomodulatory Agent
Lenalidomide + Melphalan for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Roger Pearse, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation
Patients must have histologically or cytologically confirmed relapsed, primary refractory, or relapsed and refractory multiple myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death or a maximum of 3 years, whichever occurs first
Awards & highlights
Study Summary
This trial is testing the addition of lenalidomide to standard treatment for multiple myeloma to see if it improves response rates and duration of response.
Who is the study for?
This trial is for adults over 18 with relapsed multiple myeloma who've had at least one prior treatment. They must have measurable disease, adequate organ/marrow function, and a good performance status. Participants need to agree to birth control measures and anticoagulation therapy. Exclusions include recent myeloma therapy, HIV/hepatitis infection, uncontrolled illnesses, pregnancy/lactation, history of thrombosis or allergies to the drugs tested.Check my eligibility
What is being tested?
The study aims to find the highest safe dose of lenalidomide combined with high-dose melphalan before stem cell transplantation in Phase 1. In Phase 2, it tests if this combination followed by maintenance lenalidomide can improve response rates and duration in relapsed multiple myeloma patients.See study design
What are the potential side effects?
Potential side effects may include blood disorders (like low white cells/platelets), liver issues (elevated enzymes), heart problems (reduced ejection fraction), kidney impairment (low clearance rate), risk of clotting due to prophylactic anticoagulation therapy, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have enough CD34+ stem cells collected for a transplant.
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My multiple myeloma has come back or did not respond to initial treatment.
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I am 18 years old or older.
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I am able to become pregnant and will use two forms of birth control or abstain from sex.
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I can take low-dose aspirin daily without any issues.
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I have undergone at least one treatment for my condition.
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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 willing to take blood thinner medication as required.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until death or a maximum of 3 years, whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or a maximum of 3 years, whichever occurs first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of overall response (DoR)
Maximum tolerated dose (MTD) of lenalidomide that can be added to melphalan
Secondary outcome measures
Mean Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score
Overall Response Rate
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: all patientsExperimental Treatment2 Interventions
subjects will receive daily doses of lenalidomide starting on Day -5 of transplant and melphalan on Days -2 and -1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melphalan
1994
Completed Phase 3
~3530
lenalidomide
2012
Completed Phase 3
~3920
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,246 Total Patients Enrolled
18 Trials studying Multiple Myeloma
719 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
637 Previous Clinical Trials
129,462 Total Patients Enrolled
143 Trials studying Multiple Myeloma
41,429 Patients Enrolled for Multiple Myeloma
Roger Pearse, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are normal.I have enough CD34+ stem cells collected for a transplant.I have not had a blood clot in the last 60 days.My multiple myeloma has come back or did not respond to initial treatment.I am 18 years old or older.I am able to become pregnant and will use two forms of birth control or abstain from sex.I agree to use a latex condom during sex with a female capable of becoming pregnant.I can take low-dose aspirin daily without any issues.I haven't had myeloma treatment in the last 14 days and have recovered from any previous treatment side effects.I am positive for HIV or hepatitis B/C.I do not have any uncontrolled illnesses that could affect my participation.I have undergone at least one treatment for my condition.I can take care of myself but might not be able to do heavy physical work.I am willing to take blood thinner medication as required.
Research Study Groups:
This trial has the following groups:- Group 1: all patients
Awards:
This trial has 1 awards, including:- 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.
What conditions is melphalan commonly used to address?
"Melphalan has been prescribed to alleviate the symptoms of a variety of diseases, such as amyloidosis, muscular dystrophy, and those requiring hematopoietic stem cell transplantation. It is usually recommended after two prior systemic chemotherapy regimens have proven unsuccessful."
Answered by AI
Is this research endeavor actively seeking participants?
"This medical experiment is no longer open to recruitment. The trial was posted on August 1st 2010 and its last update was April 12th 2022. At the moment, 807 studies with multiple myeloma as their focus are recruiting patients while 369 trials focusing on melphalan are actively seeking participants."
Answered by AI
How many individuals are currently involved in this clinical experiment?
"No longer actively seeking participants, this trial was initially listed on August 1st 2010 and most recently updated April 12th 2022. For those looking into other studies, 807 trials that treat multiple myeloma are currently recruiting while 369 clinical experiments related to melphalan search for patients."
Answered by AI
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