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Cancer Vaccine + Lenalidomide for Multiple Myeloma
Study Summary
This trial is testing a new cancer vaccine in patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. The vaccine is made from a survivin peptide and is given with sargramostim and incomplete Freund's adjuvant. Colony-stimulating factors like sargramostim increase the production of blood cells. Lenalidomide may stop the growth of cancer cells. Giving the vaccine before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.
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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Who is running the clinical trial?
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- You have known allergies to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF).You are expected to live for less than 4 months.I have had an autoimmune disease that needed strong medication.Your platelet count is at least 30,000 per cubic millimeter.I haven't had cancer treatments or certain medications in the last 4 weeks.I do not have an active HIV, HBV, or HCV infection, or I am only positive for HBV due to vaccination.My multiple myeloma has partially improved after initial treatment.I can take care of myself but might not be able to do heavy physical work.Your total bilirubin level must be 2 milligrams per deciliter or lower.I developed a peeling rash from taking thalidomide or similar medication.I have one of the required HLA types for the study.I agree to follow the pregnancy testing schedule as required.I have had a stem cell transplant before.I do not have any ongoing infections and haven't taken antibiotics in the last 7 days.I can take aspirin daily or use an alternative anticoagulant if needed.I have been cancer-free for over 2 years, except for some skin cancers or early-stage cervical or breast cancer.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am taking more than 2 mg of dexamethasone or its equivalent daily.Your liver enzymes (AST and ALT) are not more than three times the upper limit of normal.I have been diagnosed with plasma cell leukemia.Your absolute neutrophil count is at least 750 per cubic millimeter.
- Group 1: Group A (vaccine and week-4 lenalidomide maintenance therapy)
- Group 2: Group B (vaccine and week-0 lenalidomide maintenance therapy)
- 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
Is enrollment still open for this investigation?
"Evident from clinicaltrials.gov, the recruitment period for this trial has ended as it was first posted in April 2017 and last updated in June 2022. Nevertheless, there are over a thousand other trials at present actively recruiting patients."
What kind of adverse effects could patients face from being administered SVN53-67/M57-KLH Peptide Vaccine?
"As SVN53-67/M57-KLH Peptide Vaccine is currently in Phase 1, meaning that the safety and efficacy of this vaccine have only been tested on a small scale, our team at Power assigned it a score of one."
What medical conditions has the SVN53-67/M57-KLH Peptide Vaccine been found to help alleviate?
"SVN53-67/M57-KLH Peptide Vaccine is a commonly prescribed therapy for radiation syndrome, yet it may also be effective in managing neutropenia, chronic lymphocytic leukemia and certain types of severe infection."
How many participants are currently taking part in this research?
"This trial has ceased its recruitment of patients, with an initial post date on April 13th 2017 and the last edit made June 21st 2022. For those looking for alternative studies, 819 trials are actively recruiting people with leukemia or plasma cell conditions while 310 require participants to participate in a SVN53-67/M57-KLH Peptide Vaccine study."
What evidence exists concerning the effectiveness of SVN53-67/M57-KLH Peptide Vaccine?
"At present, there are 310 clinical investigations concerning SVN53-67/M57-KLH Peptide Vaccine. Of those running studies, 61 are presently in their third phase of development. Although most trials for this vaccine take place in Chicago, Illinois, 15126 sites across the world have these tests underway."
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