What is the mechanism of action of this treatment?

The most common treatments for Multiple Myeloma include proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and high-dose chemotherapy followed by autologous stem cell transplantation. Proteasome inhibitors, such as bortezomib, disrupt protein degradation in cancer cells, leading to cell death. Immunomodulatory drugs like lenalidomide enhance the immune system's ability to attack myeloma cells. Monoclonal antibodies, such as daratumumab, target specific proteins on myeloma cells, marking them for destruction by the immune system. High-dose chemotherapy, often followed by autologous stem cell transplantation, aims to eradicate myeloma cells and allow for the regeneration of healthy blood cells. Localized high-dose radiation, as studied in the trial, targets and destroys cancerous cells in specific areas, which is crucial for managing disease activity and reducing tumor burden in relapsed/refractory cases. These treatments are vital for Multiple Myeloma patients as they address different aspects of the disease, improving survival rates and quality of life.

What side effects are associated with this type of intervention?

Localized high-dose radiation therapy for Multiple Myeloma, such as that used in salvage radiation treatment, can lead to side effects including fatigue, skin irritation at the treatment site, and potential damage to surrounding tissues. Other common treatments for Multiple Myeloma, like chemotherapy, can cause nausea, vomiting, hair loss, and increased risk of infections. Biologic agents may lead to side effects such as infusion reactions, low blood counts, and increased risk of infections. Combining these treatments can sometimes exacerbate these side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of multiple myeloma, including bortezomib, thalidomide, lenalidomide, and combinations such as bortezomib/liposomal doxorubicin. These approvals have significantly improved responses to salvage therapy and overall survival in patients with relapsed and refractory multiple myeloma. While the trial on Salvage Radiation Treatment focuses on localized high-dose radiation, the mentioned drugs are systemic therapies that target the disease more broadly. However, these systemic treatments can be part of a comprehensive approach that may include localized therapies like radiation for specific areas of disease activity.

What other types of research exist?

Promising novel alternatives to Salvage Radiation Treatment for Multiple Myeloma patients include: 1) High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation, 2) Maintenance therapy with lenalidomide or proteasome inhibitors, 3) Chimeric Antigen Receptor T-cell (CAR-T) therapy targeting BCMA, and 4) New drug combinations with higher dose density and intensity currently being evaluated in clinical trials.

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Radiation Therapy for Multiple Myeloma

Phase 2

Recruiting

Led By Penny Fang, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Subject is diagnosed with multiple myeloma

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)

Must not have

Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment

Subject is undergoing active treatment for another malignancy other than multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a type of radiation therapy for patients with multiple myeloma who did not respond to a previous cell therapy. The radiation aims to kill the remaining cancer cells by damaging their DNA.

Who is the study for?

This trial is for adults over 18 with relapsed refractory multiple myeloma (RRMM) who have had standard BCMA CAR-T cell therapy but still show active disease on scans. They must be able to consent and have at least one treatable myeloma lesion. Pregnant women or those planning chemotherapy within two weeks of radiation are excluded.

What is being tested?

The study tests the safety and effectiveness of salvage radiation treatment after BCMA CAR-T therapy in patients with RRMM. Up to five areas can receive radiation, with doses adjusted by the physician. The main goals are to see how many respond to treatment and how long their response lasts.

What are the potential side effects?

Potential side effects from salvage radiation may include skin irritation, fatigue, nausea, loss of appetite, and localized pain where the radiation is targeted. Long-term risks could involve damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma.

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I am 18 years old or older.

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I have a myeloma lesion treatable with radiation.

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I have been treated with BCMA CAR-T cell therapy before.

Exclusion Criteria

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

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I am scheduled for chemotherapy within 2 weeks after finishing radiation.

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I am currently being treated for a cancer that is not multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Duration of response (DoR) among responders

Overall response rate (ORR)

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: Radiation TherapyExperimental Treatment1 Intervention

Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

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, immunomodulatory drugs, monoclonal antibodies, and high-dose chemotherapy followed by autologous stem cell transplantation. Proteasome inhibitors, such as bortezomib, disrupt protein degradation in cancer cells, leading to cell death. Immunomodulatory drugs like lenalidomide enhance the immune system's ability to attack myeloma cells. Monoclonal antibodies, such as daratumumab, target specific proteins on myeloma cells, marking them for destruction by the immune system. High-dose chemotherapy, often followed by autologous stem cell transplantation, aims to eradicate myeloma cells and allow for the regeneration of healthy blood cells. Localized high-dose radiation, as studied in the trial, targets and destroys cancerous cells in specific areas, which is crucial for managing disease activity and reducing tumor burden in relapsed/refractory cases. These treatments are vital for Multiple Myeloma patients as they address different aspects of the disease, improving survival rates and quality of life.

Treatment of Smoldering Multiple Myeloma: Expectant Observation Should Still Be the Standard.Treatment of relapsed and refractory multiple myeloma in the era of novel agents.How to treat patients with relapsed/refractory multiple myeloma: evidence-based information and opinions.