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Pomalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma (POM MM 014 Trial)
POM MM 014 Trial Summary
This trial will evaluate the efficacy of pomalidomide and low-dose dexamethasone or the combination of pomalidomide, daratumumab, and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma.
POM MM 014 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOM MM 014 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT02011113POM MM 014 Trial Design
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- Your platelet count is too low, depending on the percentage of a certain type of cells in your bone marrow.You are allergic to mannitol, corticosteroids, monoclonal antibodies, human proteins, or mammalian-derived products.I have severe heart failure.I do not have unstable or poorly controlled chest pain.Your blood calcium levels are higher than 11.5 mg/dL.I have been treated with pomalidomide or daratumumab before.I am currently using medication to treat myeloma.I do not have a stomach or bowel condition that affects how my body absorbs medication.I cannot or do not want to take blood clot prevention medication.My hemoglobin level is below 8 g/dL, but I may have had a blood transfusion or used erythropoietin.I agree to use a condom during sexual activity while in the study and for some time after.I agree not to donate semen during and up to 3 months after treatment.I agree not to donate blood during and for 28 days after the study.I have had 2 previous treatments for my myeloma.I have had 1 or 2 treatments for my myeloma before.My myeloma has worsened despite my last treatment.I can take care of myself and am up and about more than 50% of my waking hours.I have provided a bone marrow sample to check for specific blood cell changes.I agree to use two forms of birth control or abstain from sex, and undergo regular pregnancy tests if I join the study.I had a bone marrow or stem cell transplant less than a year ago and am still on immunosuppressants.I have HIV or active/chronic hepatitis A, B, or C.I have had hepatitis C but with no detectable virus for 6 months.I need dialysis due to severe kidney problems.I have not had a heart attack in the last 12 months.Your body has very low levels of a type of white blood cell called neutrophils.Your liver enzymes are more than three times the normal level.I have been treated with LEN or a LEN-containing regimen for at least 2 cycles recently.I have not had major surgery recently, except for kyphoplasty.You are allergic to thalidomide, LEN, or dex, or have had a severe rash from taking thalidomide or LEN before.I am an adult with MM and have measurable levels of M-protein in my blood or urine.Your blood test shows high levels of bilirubin, which may be a sign of liver problems.
- Group 1: Pomalidomide + Dexamethasone + Daratumumab
- Group 2: Pomalidomide + dexamethasone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Pomalidomide received official recognition from the FDA?
"While there is some evidence backing Pomalidomide's safety, as this is a Phase 2 trial, there is no clinical data supporting its efficacy. Consequently, it received a score of 2."
Could you please list other research studies in which Pomalidomide has been used?
"Although first studied in 2002, there has been a proliferation of clinical trials involving pomalidomide since then. Out of the 1157 completed trials, 647 are active, many of which are based in Denver, Colorado."
For what purpose is Pomalidomide most often prescribed?
"Pomalidomide is most often given to patients to help with ophthalmia, sympathetic. However, it can also be used as a form of treatment for branch retinal vein occlusion, macular edema, and communicable diseases."
Are there any patients currently being accepted into the trial?
"As of right now, this particular clinical trial is no longer looking for new participants. It was first posted on May 29th, 2014 and was edited most recently on November 3rd, 2022. There are 826 trials actively enrolling patients with multiple myeloma and 647 studies for Pomalidomide that are currently accepting new patients."
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