What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly cell therapies like CAR T cells and BiTEs, can cause several side effects. These include cytokine release syndrome (CRS) with symptoms like fever, fatigue, and low blood pressure, and neurological toxicities such as confusion, seizures, and encephalopathy. Hematologic toxicities, including neutropenia, anemia, and thrombocytopenia, increase the risk of infections and bleeding. Gastrointestinal symptoms like nausea, vomiting, and diarrhea are also frequently reported.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including lenalidomide, bortezomib, and daratumumab, which are often used in combination regimens. Lenalidomide and bortezomib are commonly used in initial and maintenance therapies, while daratumumab, an anti-CD38 monoclonal antibody, is used in various combinations for both newly diagnosed and relapsed cases. These drugs are relevant to the ongoing studies in cell therapy, which aim to utilize modified or engineered cells to target and eliminate cancer cells, potentially offering a novel approach to treatment.

What other types of research exist?

Promising novel alternatives to cell therapy for Multiple Myeloma patients in 2024 include: <ol> <li>Elotuzumab combined with lenalidomide and dexamethasone, which has shown extended progression-free survival in the ELOQUENT-2 trial.</li> <li></li> </ol> Daratumumab combined with bortezomib and dexamethasone, which has demonstrated efficacy in the CASTOR trial. 3. Pomalidomide combined with bortezomib and dexamethasone, as evidenced by the OPTIMISMM trial. 4. Selinexor combined with bortezomib and dexamethasone, which has shown positive outcomes in a phase 3 trial. 5. Carfilzomib combined with dexamethasone, which has been effective in the ENDEAVOR trial.

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CAR T-cell Therapy

Cell Therapy for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

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

Must have

Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has 'triple-refractory' disease

Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1

Must not have

Contraindication to fludarabine or cyclophosphamide

Plasma Cell Leukemia or History of Plasma Cell Leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cell therapy for patients with multiple myeloma that has come back or didn't respond to other treatments. The therapy uses specially modified cells to attack the cancer. The study also includes ongoing safety monitoring. This cell therapy has shown promising results in early studies for treating relapsed/refractory multiple myeloma.

Who is the study for?

This trial is for people with multiple myeloma who have tried at least three treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. They should not be severely ill with other conditions or have a history of plasma cell leukemia. Participants need to be relatively healthy otherwise and expected to live more than 12 weeks.

What is being tested?

The study is testing new cell therapies called ARC-T Plus Anti-BCMA SparX and CART-ddBCMA in patients whose multiple myeloma has come back or hasn't responded after several treatments. It's an early-stage trial to see if these therapies are safe and how they work.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells by mistake, infusion-related symptoms like fever or chills, fatigue, nausea, as well as risks associated with bone marrow suppression such as infections.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma has not responded to 3 types of treatments including PI, IMiD, and CD38mab.

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My doctor expects me to live more than 12 weeks and I can do most of my daily activities.

Exclusion Criteria

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

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I cannot take fludarabine or cyclophosphamide due to health reasons.

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I have or had plasma cell leukemia.

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I do not have any severe illnesses or lab results that are out of control.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 24 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)

PK Parameter for Anitocabtagene-Autoleucel: Cmax

PK Parameter for Anitocabtagene-autoleucel: Tmax

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: ARM 1Experimental Treatment1 Intervention

Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma

0 / 6Eligibility 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 like bortezomib, which block the proteasome's ability to break down proteins, leading to cancer cell death; immunomodulatory drugs like lenalidomide, which enhance the immune system's ability to attack cancer cells and inhibit their growth; and corticosteroids like dexamethasone, which reduce inflammation and kill myeloma cells. Additionally, cell therapies such as CAR T-cell therapy involve modifying a patient's T-cells to better recognize and destroy myeloma cells. These treatments are crucial for Multiple Myeloma patients as they target the cancer cells through different mechanisms, improving the chances of remission and managing the disease more effectively.