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Cancer Vaccine
Myeloma Vaccine + Lenalidomide for Multiple Myeloma
Phase 2
Waitlist Available
Led By Syed A Ali, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients must be MRD positive at 10-4 or greater by NGS sequencing at enrollment
ECOG performance scores 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 5 years
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with multiple myeloma in complete or near complete remission, currently on Revlimid therapy. They must not have high-risk myeloma features, HIV, active infections needing treatment, or other recent investigational drug use. Women must follow strict pregnancy prevention measures and men agree to use condoms.Check my eligibility
What is being tested?
The study tests if adding an allogeneic myeloma vaccine improves the effectiveness of lenalidomide in patients who are already responding well to treatment. It compares progression-free survival between those receiving the vaccine plus lenalidomide and those given a placebo with lenalidomide.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccines, blood clots due to required anticoagulation medication (aspirin or alternatives), and typical side effects of lenalidomide like fatigue, digestive issues, blood cell count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer shows minimal residual disease in tests.
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I can take care of myself and perform daily activities.
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I have multiple myeloma and have completed at least 6 cycles of treatment with lenalidomide for 3 months or more.
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My cancer is in complete remission with specific blood and bone marrow conditions.
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My cancer is almost in complete remission for 3 months, with no measurable M-spike but positive serum.
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I am older than 18 years.
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I am currently taking Revlimid.
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I can take blood thinners like aspirin, warfarin, or heparin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year progression free survival
Secondary outcome measures
Evaluate toxicity of allogenic myeloma vaccine
MRD Conversion Rate
Measure tumor specific immunity and correlate with systemic immunity
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lenalidomide plus GM-CSF Vaccine plus Prevnar13Experimental Treatment3 Interventions
Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.
Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Prevnar vaccine will be administered with the GM-CSF vaccine administration.
Group II: Lenalidomide plus GM-CSF VaccinePlacebo Group3 Interventions
Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.
Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Patients will also be administered a placebo prevnar13 vaccination. Placebo will be saline.
Group III: Lenalidomide OnlyPlacebo Group3 Interventions
Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients will also get placebo GM-CSF vaccine and placebo prevnar13. Placebo will be saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Prevnar13
2016
Completed Phase 4
~2460
Find a Location
Who is running the clinical trial?
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,917 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,809 Patients Enrolled for Multiple Myeloma
Aduro Biotech, Inc.Industry Sponsor
12 Previous Clinical Trials
750 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,846 Total Patients Enrolled
27 Trials studying Multiple Myeloma
1,233 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide plus GM-CSF Vaccine plus Prevnar13
- Group 2: Lenalidomide plus GM-CSF Vaccine
- Group 3: Lenalidomide Only
Awards:
This trial has 0 awards, including: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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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