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Myeloma Vaccine + Lenalidomide for Multiple Myeloma
Study Summary
This trial is testing whether adding an allogeneic myeloma vaccine to lenalidomide treatment can improve outcomes for patients in near complete or complete remission.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a history of specific proteins in your blood or urine.Your absolute neutrophil count is above 1000 per microliter.You are expected to live for at least 12 more months.Your corrected serum calcium level is less than 11 mg/dL, and you don't have any symptoms of high calcium levels.Your blood creatinine level is less than 2 mg/dl.Your platelet count is higher than 100,000 per microliter.Your liver enzymes (AST and ALT) are not more than 3 times the upper limit of normal.My cancer shows minimal residual disease in tests.I have been diagnosed with POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma, or amyloidosis.Your total bilirubin level is within a certain range.I do not have HIV or any active infections needing treatment within the last 2 weeks.I have had cancer other than myeloma.I am currently being treated for an autoimmune disease.I have had a transplant from a donor.I can take care of myself and perform daily activities.My myeloma is high-risk based on specific genetic features or a quick relapse.I agree to continue my treatment with lenalidomide alongside the vaccine until my condition worsens.My condition worsened after I stopped taking corticosteroids, shown by specific blood or urine tests.My light chain myeloma is in complete remission according to 2016 IMWG criteria.My light chain myeloma is almost in complete remission according to 2016 criteria.I have been cancer-free for 5 years, except for certain skin cancers or localized cancers of the uterus, cervix, or breast.I agree to follow the pregnancy testing schedule as required.I am not pregnant, will use two forms of birth control, and agree to regular pregnancy tests while taking lenalidomide.I have multiple myeloma and have completed at least 6 cycles of treatment with lenalidomide for 3 months or more.I have multiple myeloma and haven't taken corticosteroids for 4 weeks.My cancer is in complete remission with specific blood and bone marrow conditions.My cancer is almost in complete remission for 3 months, with no measurable M-spike but positive serum.I am older than 18 years.I had a stem cell transplant for my multiple myeloma over a year ago.I am currently taking Revlimid.My cancer does not show up in a highly sensitive blood test.I can take blood thinners like aspirin, warfarin, or heparin.
- Group 1: Lenalidomide plus GM-CSF Vaccine plus Prevnar13
- Group 2: Lenalidomide plus GM-CSF Vaccine
- Group 3: Lenalidomide Only
- 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 the GM-CSF vaccine been given regulatory clearance by the FDA?
"Our team at Power has assigned a safety rating of 2 out of 3 to the GM-CSF vaccine, as its Phase 2 status suggests preliminary evidence for safety but no definitive proof is available yet."
What has been the primary application of GM-CSF vaccine?
"GM-CSF vaccine is frequently prescribed to patients with multiple myeloma, as well as those undergoing chemotherapy for various other conditions such as relapsed and/or refractory lymphomas and chronic lymphocytic leukemias."
Are there any open slots available for enrolment in this trial?
"According to clinicaltrials.gov, the recruitment process for this trial has concluded; it was first posted on September 23rd 2019 and last updated on September 12th 2022. Although no longer open for enrollment, there are still 1,075 other medical studies actively searching for candidates at present."
How numerous are the participants in this investigation?
"Unfortunately, this research project has surpassed its recruitment phase. Originally posted in September of 2019 and most recently edited 12 months ago, it is no longer open to new patients. However, there are 807 clinical trials for multiple myeloma that require participants as well as 268 studies about GM-CSF vaccines currently seeking enrolment."
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