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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

Must not have

Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma and amyloidosis

History of an active malignancy other than myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 5 years

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with POEMS syndrome, plasma cell leukemia, CNS involvement, non-secretory myeloma, or amyloidosis.

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I have had cancer other than myeloma.

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I am currently being treated for an autoimmune disease.

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I have had a transplant from a donor.

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My myeloma is high-risk based on specific genetic features or a quick relapse.

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My condition worsened after I stopped taking corticosteroids, shown by specific blood or urine tests.

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My cancer does not show up in a highly sensitive blood test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-year progression free survival

Secondary study objectives

Evaluate toxicity of allogenic myeloma vaccine

MRD Conversion Rate

Progression Free Survival (PFS)

+2 more

Trial 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

~2240

Prevnar13

2016

Completed Phase 4

~2460