What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, carfilzomib, lenalidomide, and pomalidomide, are associated with several side effects. These include hematologic toxicities like neutropenia, thrombocytopenia, and anemia. Non-hematologic adverse events often reported are neuropathy, fatigue, gastrointestinal issues (such as diarrhea and nausea), and infections. Specifically, for CAR-T cell therapies like PHE885, potential side effects may include cytokine release syndrome and neurotoxicity, although these were not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including BCMA-directed therapies and CAR-T cell therapies. One notable BCMA-directed CAR-T cell therapy is idecabtagene vicleucel (Abecma), which targets the B-cell maturation antigen (BCMA) and has shown efficacy in relapsed or refractory Multiple Myeloma. Another similar therapy is ciltacabtagene autoleucel (Carvykti), also targeting BCMA. These therapies represent significant advancements in the treatment of Multiple Myeloma, offering new options for patients with relapsed or refractory disease.

What other types of research exist?

Promising, novel alternatives to PHE885 for Multiple Myeloma patients include: 1) Anti-BCMA CAR-T cell therapy combined with lenalidomide, which has shown feasibility and effectiveness in patients refractory to previous CAR-T treatments. 2) Selinexor, an oral selective inhibitor of nuclear export, which has demonstrated efficacy in combination with bortezomib and dexamethasone. 3) Daratumumab, a monoclonal antibody targeting CD38, used in combination with carfilzomib and dexamethasone, which has shown improved outcomes in relapsed or refractory multiple myeloma.

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CAR T-cell Therapy

CAR-T Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening

Must not have

POEMS syndrome

Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment where a patient's immune cells are modified to fight multiple myeloma in adults who haven't responded to other treatments. The modified cells target and kill the cancer cells. This approach has shown promise in treating multiple myeloma.

Who is the study for?

Adults over 18 with multiple myeloma that's come back or hasn't responded after at least three treatments, including specific drugs like IMiDs and proteasome inhibitors. They must have measurable disease, be in good physical condition (ECOG 0-1), and have cells ready for making the CAR-T therapy. Not eligible if they've had certain other myeloma treatments, recent bone marrow transplants, plasma cell leukemia, CNS involvement by cancer, autoimmune neurological conditions, or poor organ function.

What is being tested?

The trial is testing PHE885 CAR-T therapy on adults with relapsed/refractory multiple myeloma. It's a Phase II study to see how well it works and its safety when made using a new process. Participants will receive this single-agent treatment to evaluate its effectiveness against their cancer.

What are the potential side effects?

Potential side effects of PHE885 may include immune system reactions leading to symptoms in various organs (like fever or fatigue), infusion-related reactions where the therapy is given into the vein, blood count changes increasing infection risk; exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My leukapheresis material is approved for use.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I've had 3+ treatments for my condition, including specific drugs, and my disease is still getting worse.

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.

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I have previously received genetically modified cell therapy, including BCMA CAR-T.

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I have previously received BCMA-targeted therapy.

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My condition is not multiple myeloma but another plasma cell disorder.

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My cancer has spread to my brain or spinal cord.

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I have an active neurological autoimmune or inflammatory disorder.

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My heart, kidneys, liver, or blood are not functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Heart rate

Secondary study objectives

Cellular kinetics parameter: AUC

Cellular kinetics parameter: Cmax

Cellular kinetics parameter: Tmax

+15 more

Other study objectives

Key Measure

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PHE885Experimental Treatment1 Intervention

Patients will receive PHE885

0 / 11Eligibility 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

The most common treatments for Multiple Myeloma include proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and BCMA-directed therapies. Proteasome inhibitors (e.g., bortezomib, carfilzomib) block the proteasome's function, leading to the accumulation of proteins that induce cancer cell death. Immunomodulatory drugs (e.g., lenalidomide, pomalidomide) enhance the immune system's ability to attack myeloma cells and inhibit their growth. Monoclonal antibodies (e.g., daratumumab, isatuximab) target specific proteins on myeloma cells, marking them for destruction by the immune system. BCMA-directed therapies, such as CAR-T cells, involve engineering a patient's T cells to target and kill myeloma cells expressing the BCMA protein. These treatments are crucial as they offer targeted approaches to eliminate myeloma cells, improve response rates, and extend the duration of remission for patients.

How best to use new therapies in multiple myeloma.