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Corticosteroid
Dexamethasone + Elotuzumab + Pomalidomide for Multiple Myeloma
Phase 2
Waitlist Available
Led By Sikander Ailawadhi, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Pathologically confirmed diagnosis of multiple myeloma and noted to have progressive disease (International Myeloma Working Group [IMWG] criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with multiple myeloma that hasn't responded to previous treatment. The drugs work in different ways to stop the growth of cancer cells.
Who is the study for?
Adults with multiple myeloma that hasn't improved after treatment can join this trial. They must have had at least one prior therapy, be in decent physical shape, and not be pregnant or breastfeeding. Participants need to agree to birth control use and follow specific drug safety programs. People who've had certain recent surgeries, severe lung conditions, heart issues, liver disease, active infections or other cancers within the last 3 years cannot join.Check my eligibility
What is being tested?
The trial is testing a combination of dexamethasone (a steroid), elotuzumab (an immune system-boosting antibody), and pomalidomide (a drug that blocks tumor blood vessel growth) on patients whose multiple myeloma has resisted previous treatments. The goal is to see if this combo is more effective for these patients.See study design
What are the potential side effects?
Possible side effects include weakened immune response leading to infections, allergic reactions from the antibody treatment, potential blood clots due to pomalidomide's effect on blood vessels, fatigue from dexamethasone as well as risks of bone marrow suppression which could lead to anemia or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My multiple myeloma is worsening according to IMWG criteria.
Select...
I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) defined as a partial response, very good partial response, complete response (CR) or stringent CR (sCR)
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Percentage of patients achieving CR
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dexamethasone, elotuzumab, pomalidomide)Experimental Treatment3 Interventions
Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Pomalidomide
FDA approved
Elotuzumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,231 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,090 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,819 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,670 Patients Enrolled for Multiple Myeloma
Sikander Ailawadhi, M.D.Principal InvestigatorMayo Clinic
3 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Multiple Myeloma
60 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting tests are normal or within the target range if I'm on blood thinners.I am willing to follow the Revlimid/Pomalyst REMS program requirements.I have severe COPD or asthma with less than 60% of the normal lung function.You must have measurable disease within 14 days before joining the study.My condition did not improve with pomalidomide treatment.I am 18 years old or older.I do not have severe heart problems or recent heart attacks.I am not willing to use birth control.I have previously been treated with elotuzumab.My multiple myeloma is worsening according to IMWG criteria.Your platelet count needs to be at least 50,000 cells/mm^3 if you have less than 50% bone marrow plasmacytosis, or at least 30,000 cells/mm^3 if you have 50% or more bone marrow plasmacytosis. This will be checked within 14 days before you join the study.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.My condition is either non-secretory MM or AL amyloidosis.Your total bilirubin level should be no more than 1.5 times the upper limit of normal, unless you have Gilbert's syndrome, in which case your direct bilirubin level should also be no more than 1.5 times the upper limit of normal.I have not had any other cancer within the last 3 years.I have not had a stroke or brain bleed in the last 6 months.I have not needed IV antibiotics for an infection in the last 2 weeks.I have not had major surgery in the last 4 weeks.I have received at least one treatment for my condition before.My condition worsened while on or shortly after daratumumab treatment.My white blood cell count is healthy without needing medication.I am immunocompromised or HIV positive and on antiretroviral therapy.Your liver enzymes (ALT and AST) are not more than three times the upper limit of normal.I have severe nerve damage or POEMS syndrome.I have severe liver problems.I am able to care for myself and perform daily activities.Women who could become pregnant need to have a negative pregnancy test within 14 days before joining the study.Your kidney function, as measured by creatinine clearance, is at least 30 ml/min.My multiple myeloma has spread to the lining of my brain and spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dexamethasone, elotuzumab, pomalidomide)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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 researchers actively looking for participants in this experiment?
"This particular study, which was first announced on December 19th 2018 and last updated September 23rd 2022, is not currently seeking new enrollees. Although this may be the case, there are 1431 other trials that are still recruiting patients."
Answered by AI
What is the mortality rate for patients who undergo this treatment?
"Since this is a phase 2 trial, and therefore there is only anecdotal evidence for the safety of the proposed treatment (dexamethasone, elotuzumab, pomalidomide), it received a score of 2."
Answered by AI
What condition does this dexamethasone, elotuzumab, pomalidomide treatment target?
"Dexamethasone, elotuzumab, and pomalidomide are often used to treat ophthalmia. They can also help patients with branch retinal vein occlusion, macular edema, and other conditions affecting the eye."
Answered by AI
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