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Elotuzumab + Mezigdomide + Dexamethasone for Multiple Myeloma
Phase 1
Recruiting
Led By Abdullah M Khan, MBBS, MSc
Research Sponsored by Abdullah Khan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Calculated creatinine clearance of >= 45ml/min using Modification of Diet in Renal Disease (MDRD) formula
Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests a combo of drugs for treating multiple myeloma in those who have relapsed or not responded to other treatments. Elotuzumab, CC-92480 and dexamethasone are used to target proteins on myeloma cells and help the body's immune system kill them.
Who is the study for?
Adults with relapsed or refractory multiple myeloma who've had at least two prior treatments including lenalidomide, a proteasome inhibitor, anti-CD38 antibody, and BCMA-targeted therapy. They must have proper heart function, be able to swallow pills, and have adequate blood counts and liver/kidney function. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of CC-92480 with elotuzumab and dexamethasone for safety, side effects, and optimal dosage in patients whose multiple myeloma has returned or resisted treatment. These drugs work together to target cancer cells more effectively.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to elotuzumab targeting specific proteins on cancer cells; CC-92480 may cause cell death leading to various symptoms; dexamethasone can affect water/chemical balance regulated by kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys work well enough, with a creatinine clearance of 45ml/min or more.
Select...
I am 18 or older with myeloma that has come back or didn’t respond to treatment.
Select...
I have been treated with at least 2 therapies including lenalidomide, a proteasome inhibitor, an anti-CD38 antibody, and BCMA-targeted therapy.
Select...
I do not have any heart rhythm problems that aren't under control.
Select...
I do not have severe heart failure.
Select...
I can do all or most of my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
The recommended phase 2 dose of mezigdomide (CC-92480) in combination with elotuzumab and dexamethasone
Secondary outcome measures
Changes in expression of CRBN, Ikaros, and Aiolos with therapy
Changes in immunophenotype of multiple myeloma cells
Changes in lymphocyte subsets with therapy
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (elotuzumab, CC-92480, dexamethasone)Experimental Treatment10 Interventions
Patients receive elotuzumab IV on days 1, 8, 15, and 22 of cycles 1 and 2 and then on day 1 of each subsequent cycle. Patients also receive CC-92480 PO on days 1-21 of each cycle and dexamethasone IV or PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo an ECHO during screening and undergo MRI, CT, or x-ray imaging during screening and on study as clinically indicated. Patients also undergo blood sample collection as well as bone marrow biopsy and aspiration during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Computed Tomography
2017
Completed Phase 2
~2720
Mezigdomide
2023
Completed Phase 1
~40
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Elotuzumab
2016
Completed Phase 3
~800
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
Abdullah KhanLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Multiple Myeloma
1 Patients Enrolled for Multiple Myeloma
Abdullah M Khan, MBBS, MScPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Multiple Myeloma
1 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ECG test shows a QT interval of less than or equal to 470 milliseconds.I do not have high-risk heart conditions.I am taking corticosteroids for reasons other than basic bodily functions.Your liver enzymes (AST, ALT, and alkaline phosphatase) should be less than 2.5 times the upper limit of normal.My kidneys work well enough, with a creatinine clearance of 45ml/min or more.I am using two reliable birth control methods or abstaining from sex.I am not using alternative medicines that could affect the study's drug results.I have had GI surgery that may affect how I absorb or swallow medication.I am 18 or older with myeloma that has come back or didn’t respond to treatment.Your hemoglobin level must be 7g/dL or higher.Your absolute neutrophil count is 1000 or higher.Your platelet count is at least 70,000 per microliter.Your total bilirubin level is within a certain range.I haven't taken any experimental or targeted cancer drugs in the last 2 weeks or recovered from their side effects.I have been treated with at least 2 therapies including lenalidomide, a proteasome inhibitor, an anti-CD38 antibody, and BCMA-targeted therapy.You have certain health issues that could make breathing risky.Your heart's pumping function is not too low.I do not have any heart rhythm problems that aren't under control.I do not have severe heart failure.I can swallow pills.I had major surgery less than 2 weeks ago or am still dealing with its side effects.I do not have an active, significant cancer other than my current diagnosis, except for non-melanoma skin cancer or carcinoma in situ of the cervix or breast.I have been diagnosed with Waldenstrom macroglobulinemia, AL amyloidosis, primary plasma cell leukemia, or POEMS syndrome.You have HIV or hepatitis C.I do not have severe nerve damage or pain from it.I will not donate sperm during and for 6 months after the study.I agree to use birth control during and up to 6 months after the study.I can do all or most of my daily activities without help.You have had a serious allergic reaction to elotuzumab, lenalidomide, or pomalidomide in the past.I haven't taken strong CYP3A modulators or proton-pump inhibitors in the last 2 weeks.You currently have active hepatitis B, as shown by a positive HBsAg test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (elotuzumab, CC-92480, dexamethasone)
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.
Has the combination of elotuzumab, CC-92480 and dexamethasone been sanctioned by the FDA?
"Our team has assigned the treatment of elotuzumab, CC-92480, and dexamethasone a score of 1 due to its lack of clinical data that proves safety or efficacy."
Answered by AI
Are investigators currently recruiting for this research project?
"Per clinicaltrials.gov, this study is not currently seeking participants. The trial was initially announced on September 1st 2023 and its status has been updated to reflect that it is no longer recruiting as of August 1st 2023. However, 820 other trials are actively looking for candidates at present."
Answered by AI
What are the end goals of this research experiment?
"This clinical trial will span up to 28 days, with the primary objective being to evaluate adverse events. Secondary outcomes including Time To Progression (TTP), Time To Response (TTR) and Duration Of Response (DOR). IMWG response criteria will be used for assessment of antitumor activity, while Gray's test and Kaplan-Meier methods are employed for analysis of TTP and DOR respectively. 95% CIs and log-rank tests shall also be utilized in comparison between patient subgroups."
Answered by AI
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