What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma that induce an immune response, such as immunotherapies and monoclonal antibodies, often have side effects including fatigue, infections, gastrointestinal issues (nausea, diarrhea), and cytopenias (anemia, neutropenia, thrombocytopenia). Lenalidomide, frequently used in maintenance therapy, can cause side effects like fatigue, rash, diarrhea, and an increased risk of blood clots. These treatments aim to enhance the body's immune response to target cancer cells but can also lead to immune-related adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that focus on inducing an immune response against cancer cells. Notable examples include monoclonal antibodies such as Daratumumab, which targets CD38 on myeloma cells, and Elotuzumab, which targets SLAMF7. Additionally, immunomodulatory drugs like Lenalidomide and Pomalidomide have been approved, which enhance the immune system's ability to fight cancer. These treatments, while not identical, share a similar goal of leveraging the immune system to combat Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to the SVN53-67/M57-KLH peptide vaccine for Multiple Myeloma patients include: 1) Monoclonal antibody therapies such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways and have shown efficacy in various cancers. 2) Oncolytic virus therapies, such as engineered measles virus (MV), which can be genetically modified to target specific cancer cells. 3) Immunotoxins like mHALT-1-scFv, which have demonstrated cytotoxic effects on cancer cells with minimal impact on normal cells. These therapies represent innovative approaches that could be considered in treatment plans for Multiple Myeloma.

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Cancer Vaccine

Cancer Vaccine + Lenalidomide for Multiple Myeloma

Phase 1

Waitlist Available

Led By Jens Hillengass, MD, PhD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11, or HLA-A*24

Patients with newly diagnosed multiple myeloma who have at least a partial response after induction therapy based on the International Working Group (IWG) Uniform Response Criteria

Must not have

Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement

The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a vaccine which targets a protein found in cancer cells may help treat multiple myeloma.

Who is the study for?

This trial is for newly diagnosed multiple myeloma patients who've responded to initial therapy, have specific HLA types (HLA-A*02, A*03, A*11, or A*24), and meet certain health criteria like good organ function and no serious infections. They must not be pregnant or breastfeeding and should agree to the Revlimid REMS® program's requirements.

What is being tested?

The study tests a SVN53-67/M57-KLH peptide vaccine with incomplete Freund's adjuvant plus sargramostim in patients on lenalidomide maintenance therapy. The goal is to see if this combination can stimulate an immune response that targets cancer cells expressing survivin.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms from the immune response such as fever and chills, fatigue due to increased blood cell production by sargramostim, and typical lenalidomide effects like rash or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have one of the required HLA types for the study.

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My multiple myeloma has partially improved after initial treatment.

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I can take care of myself but might not be able to do heavy physical work.

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My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).

Exclusion Criteria

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

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I have had an autoimmune disease that needed strong medication.

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I developed a peeling rash from taking thalidomide or similar medication.

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I am taking more than 2 mg of dexamethasone or its equivalent daily.

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I have been diagnosed with plasma cell leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Toxicity profile of the SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant plus sargramostim, given before or after the start of lenalidomide maintenance

Secondary study objectives

Immune response using interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) and multimer assays

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B (vaccine and week-0 lenalidomide maintenance therapy)Experimental Treatment5 Interventions

Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 4, 6, 8, and 10 for up to 4 doses and then receive a booster in week 16. Beginning in week 0, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.

Group II: Group A (vaccine and week-4 lenalidomide maintenance therapy)Experimental Treatment5 Interventions

Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 0, 2, 4, and 6 for up to 4 doses and then receive a booster in week 12. Beginning in week 4, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2006

Completed Phase 4

~880

Lenalidomide

2005

Completed Phase 3

~2240

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Myeloma include immunomodulatory drugs (e.g., lenalidomide), proteasome inhibitors (e.g., bortezomib), monoclonal antibodies (e.g., daratumumab), and CAR T-cell therapies. These treatments work by enhancing the immune system's ability to recognize and destroy myeloma cells, inhibiting essential cellular processes in cancer cells, and directly targeting specific antigens on myeloma cells. For instance, lenalidomide boosts immune responses and inhibits tumor growth, while CAR T-cell therapies engineer a patient's T-cells to target and kill myeloma cells. These mechanisms are crucial as they offer targeted and effective ways to manage and potentially eradicate the disease, improving patient outcomes.

Current challenges and opportunities in treating adult patients with Philadelphia-negative acute lymphoblastic leukaemia.Current vaccination strategies for the treatment of B-cell lymphoma and multiple myeloma.