Radiation Therapy for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Other malignancy, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Radiation Therapy for Multiple Myeloma?
Intraoperative radiotherapy (IORT), a component of radiation therapy, has shown effectiveness in improving local control and survival rates in various cancers, such as breast cancer and recurrent colorectal cancers, by delivering precise radiation doses during surgery. This suggests potential benefits for its use in treating multiple myeloma, although specific data for this condition is not provided.
12345Is radiation therapy generally safe for humans?
Radiation therapy is generally safe for humans, but it can cause side effects. Studies show that advanced techniques like intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) can reduce some side effects, but there are still risks of gastrointestinal and genitourinary issues, especially with higher doses.
678910How does radiation therapy differ from other treatments for multiple myeloma?
Radiation therapy for multiple myeloma is unique because it is primarily used to relieve symptoms like bone pain and to help strengthen bones, rather than directly targeting the cancer cells. Unlike other treatments such as immunomodulatory drugs and proteasome inhibitors, which aim to control the disease itself, radiation therapy focuses on improving quality of life by managing pain and preventing complications.
1112131415Eligibility Criteria
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.Inclusion Criteria
My scan 30 days after CAR-T therapy shows the cancer is still active.
I have been diagnosed with multiple myeloma.
I am 18 years old or older.
+3 more
Exclusion Criteria
Pregnant women will be excluded from this study.
I am scheduled for chemotherapy within 2 weeks after finishing radiation.
I am currently being treated for a cancer that is not multiple myeloma.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Treatment
Radiation treatment to bony or soft tissue plasmacytomas in up to five fields with doses of 10-20Gy
2-3 weeks
Follow-up
Participants are monitored for safety and effectiveness after radiation treatment
6 months
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Intraoperative radiotherapy: review of techniques and results. [2020]Intraoperative radiotherapy (IORT) is a technique that involves precise delivery of a large dose of ionising radiation to the tumour or tumour bed during surgery. Direct visualisation of the tumour bed and ability to space out the normal tissues from the tumour bed allows maximisation of the dose to the tumour while minimising the dose to normal tissues. This results in an improved therapeutic ratio with IORT. Although it was introduced in the 1960s, it has seen a resurgence of popularity with the introduction of self-shielding mobile linear accelerators and low-kV IORT devices, which by eliminating the logistical issues of transport of the patient during surgery for radiotherapy or building a shielded operating room, has enabled its wider use in the community. Electrons, low-kV X-rays and HDR brachytherapy are all different methods of IORT in current clinical use. Each method has its own unique set of advantages and disadvantages, its own set of indications where one may be better suited than the other, and each requires a specific kind of expertise. IORT has demonstrated its efficacy in a wide variety of intra-abdominal tumours, recurrent colorectal cancers, recurrent gynaecological cancers, and soft-tissue tumours. Recently, it has emerged as an attractive treatment option for selected, early-stage breast cancer, owing to the ability to complete the entire course of radiotherapy during surgery. IORT has been used in a multitude of roles across these sites, for dose escalation (retroperitoneal sarcoma), EBRT dose de-escalation (paediatric tumours), as sole radiation modality (early breast cancers) and as a re-irradiation modality (recurrent rectal and gynaecological cancers). This article aims to provide a review of the rationale, techniques, and outcomes for IORT across different sites relevant to current clinical practice.
Intraoperative radiation therapy. [2022]Intraoperative radiation therapy (IORT) is the delivery of irradiation at the time of an operation. This is performed by different techniques including intraoperative electron beam techniques and high-dose rate brachytherapy. IORT is usually given in combination with external-beam radiation therapy with or without chemotherapy and surgical resection. IORT excludes part or all dose-limiting sensitive structures, thereby increasing the effective dose to the tumor bed (and therefore local control) without significantly increasing normal tissue morbidity. Despite best contemporary therapy, high rates of local failure occur in patients with locally advanced or recurrent rectal cancer, retroperitoneal sarcoma, select gynecologic cancers, and other malignancies. The addition of IORT to conventional treatment methods has improved local control as well as survival in many disease sites in both the primary and locally recurrent disease settings. More recently, there has been interest in the use of IORT as a technique of partial breast irradiation for women with early breast cancer. Given newer and lower cost treatment devices, the use of IORT in clinical practice will likely grow, with increasing integration into the treatment of nonconventional malignancies. Optimally, phase III randomized trials will be carried out to prove its efficacy in these disease sites.
Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. [2021]Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters.
Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]Intraoperative radiotherapy (IORT) permits accurate delivery of radiation therapy directly to the tumor bed. We report local, regional, and distant recurrence data along with overall and breast cancer-specific survival for 1400 tumors treated with x-ray IORT.
Intraoperative radiotherapy boost as part of breast-conservation therapy for breast cancer: a single-institution retrospective analysis. [2022]There are currently no data from randomized controlled trials on the use of intraoperative radiotherapy (IORT) as a tumor bed boost as part of a breast-conservation approach for breast cancer. This study retrospectively reviewed the safety and efficacy of IORT as a boost treatment at a tertiary cancer center.
Adverse events of local treatment in long-term head and neck rhabdomyosarcoma survivors after external beam radiotherapy or AMORE treatment. [2015]Radiotherapy is a well-known cause of adverse events (AEs). To reduce AEs, an innovative local treatment was developed in Amsterdam: Ablative surgery, MOuld brachytherapy and surgical REconstruction (AMORE).
A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. [2022]To compare the toxicity and biochemical outcomes of intensity-modulated radiation therapy (IMRT) and (125)I transperineal permanent prostate seed implant ((125)I) for patients with low-risk prostate cancer.
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]Intensity-modulated radiation therapy (IMRT) is a major therapeutic option for localized prostate cancer. Image-guided radiation therapy (IGRT) allows tumor visualization and corrects the errors caused by daily internal movement of the prostate. The current study retrospectively compared the acute toxicities and biochemical tumor control outcomes of prostate IMRT achieved using two IGRT techniques: bony structure-based IGRT (B-IGRT) and prostate-based IGRT (P-IGRT).
Tools for risk assessment in radiation therapy. [2019]Radiotherapy has unquestionable benefits, but it is also associated with unique and specific safety issues. It is the only application of radiation in which humans are intentionally delivered very high doses. Safety in radiotherapy remains heavily dependent on human actions. A step-by-step approach is suggested for the prevention of accidental exposures in radiation therapy: (1) allocation of responsibilities to qualified professionals, and design of a quality and safety programme - no radiotherapy practice should be operated without these key elements; (2) use of the lessons from accidental exposures to test whether the quality and safety programme is sufficiently robust against these types of events -publications by the International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency provide a collection of lessons to facilitate this step; and (3) find other latent risks by posing the questions 'What else could go wrong?' or 'What other potential hazards might be present?' in a systematic, anticipative manner - methods to do so are described briefly in ICRP Publication 112.
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p
Current role of radiation therapy for multiple myeloma. [2022]Radiation therapy (RT) is a treatment modality traditionally used in patients with multiple myeloma (MM), but little is known regarding the role and effectiveness of RT in the era of novel agents, i.e., immunomodulatory drugs and proteasome inhibitors.
Real-world Utilization of Radiation Therapy in Multiple Myeloma: An Analysis of the Connect® MM Registry. [2023]Radiation therapy (RT) is an important treatment modality for patients with multiple myeloma (MM). While patients are living longer with MM, they are more likely to suffer from comorbidities related to treatment such as bone pain; however, RT can provide symptom relief. To date, the characterization of patients who have received RT in the real-world setting has been limited.
The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions. [2022]Radiotherapy is required to overcome pain and to promote recalcification in multiple myeloma (MM) patients. The aim of our prospective study was to evaluate the impact of one fraction of 8 Gy regimen in palliative treatment of MM.
Fracture rate after conventional external beam radiation therapy to the spine in multiple myeloma patients. [2023]Conventional external beam radiation therapy (cEBRT) is used in multiple myeloma (MM) to treat severe pain, spinal cord compression, and disease-related bone disease. However, radiation may be associated with an increased risk of vertebral compression fractures (VCFs), which could substantially impair survival and quality of life. Additionally, the use of the Spinal Instability Neoplastic Score (SINS) in MM is debated in MM.
[Palliative radiation therapy for multiple myeloma]. [2011]Radiation therapy is a useful palliative modality for refractory lesions of multiple myeloma. It has been reported that total doses of 10 to 20 Gy are usually adequate to obtain some degree of pain relief. However, there are many patients who need additional doses to obtain sufficient pain relief. In this study, we retrospectively analyzed the records of patients with multiple myeloma irradiated at our department, in an attempt to develop an effective treatment policy for this disease.