CLINICAL TRIAL

Total Marrow Irradiation for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18 - 65 · All Sexes · Ottawa, Canada

This study is evaluating whether a higher dose of radiation can be given to patients with multiple myeloma without increasing the toxicity to normal tissues.

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About the trial for Multiple Myeloma

Eligible Conditions
Neoplasms, Plasma Cell · Multiple Myeloma

Treatment Groups

This trial involves 2 different treatments. Total Marrow Irradiation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Total Marrow Irradiation
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Marrow Irradiation
2014
Completed Phase 1
~20

Eligibility

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person must have primary refractory or relapsed multiple myeloma. show original
The subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse. show original
Subject must meet institutional guidelines for autologous HSCT show original
If you want to receive an autologous hematopoietic stem cell transplant, you must have more than 2.5 million CD34+ cells per kg of your body weight frozen and ready for the procedure. show original
The subject must be at least 18 years old and have a stable medical condition show original
The subject must be able to comply with the protocol's visit schedule and other requirements. show original
The subject must be at least 18 years old, but no more than 60 years old. show original
Subject must have an ECOG performance score of 0, 1, or 2 in order to be eligible for the study show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Beyond 6 months after transplantaton
Screening: ~3 weeks
Treatment: Varies
Reporting: Beyond 6 months after transplantaton
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Beyond 6 months after transplantaton.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Total Marrow Irradiation will improve 1 primary outcome and 4 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 30 days from the time of aSCT.

To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
30 DAYS FROM THE TIME OF ASCT
30 DAYS FROM THE TIME OF ASCT
The frequency and timing of engraftment following TMI and aHSCT
WITHIN 30 DAYS OF AHSCT
WITHIN 30 DAYS OF AHSCT
The early morbidity and mortality associated with TMI and aHSCT
30 DAYS FROM AHSCT
30 DAYS FROM AHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
100 DAYS FROM AHSCT
100 DAYS FROM AHSCT
The late morbidity of TMI
BEYOND 6 MONTHS AFTER TRANSPLANTATON
BEYOND 6 MONTHS AFTER TRANSPLANTATON

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for multiple myeloma?

There is a wide range of therapies options in multiple myeloma treatment. Many recent research studies on multiple myeloma and its drugs are published in “Hematology” and “Current Research in Oncology” journals. For example, there are many new drugs being studied as treatment options for multiple myeloma, such as bortezomib, ixabepilone and others. The advent of the next-generation therapies such as immunotherapy, bortezomib, lenalidomide, and carfilzomib as treatment options has dramatically improved multiple myeloma patient's survival and progression-free survival.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a blood cancer that almost always begins with a nondiagnostic bone marrow biopsy. Treatment typically entails systemic anticancer therapy, most prominently bortezomib and lenalidomide. More than half of the patients receiving bortezomib and lenalidomide ultimately succumb to those drugs. Survival is often improved when patients are managed by a myeloma specialist. Patient groups that require attention are those whose disease is highly progressive, has relapsed after initial bortezomib and lenalidomide treatments, or whose disease has progressed after either bortezomib-based and lenalidomide and dexamethasone-based treatments.

Anonymous Patient Answer

What causes multiple myeloma?

The risk of development of multiple myeloma is increased in individuals who have antibodies present against hepatitis C virus, in individuals with a single family member with multiple myeloma, in individuals who are first-degree relatives of a person with multiple myeloma, and in individuals of black or Hispanic ethnicity in the United States. Further studies are needed to identify the genetic susceptibility and the etiological factors for this disease, and to determine the usefulness of screening individuals for hepatitis C virus antibody status, genetic testing of family members, and surveillance of risk factors to identify individuals who are at increased risk for multiple myeloma.

Anonymous Patient Answer

What are the signs of multiple myeloma?

In a patient with symptomatic MM, the most common signs are appetite loss, weight loss, thrombocytosis, and anemia. More than 60% of patients have evidence of osteolysis. Other features of the disease in the skeleton may include lytic bone lesions, pathologic fractures, and pathologic fractures from bone pain or pain originating from metastases. Pain arising from iliopsoas and adhesions can also cause bone pain. Osteoexcitability, as evidenced by pathologic fractures from trauma, is less common in the skeleton compared with the soft tissues of the skull and maxillofacial area.

Anonymous Patient Answer

How many people get multiple myeloma a year in the United States?

This is the first estimate of the number of cases of MM in the United States that was determined from Medicare claim data. The number and age distributions of people with MM in the United States are similar to the global burden of disease.

Anonymous Patient Answer

Can multiple myeloma be cured?

MM can be cured, but patients with multiple relapses or who are amyloidosis negative will be very likely to relapse. In the early stages, as with other B-cell malignancies, remission is achievable with good induction regimens, frequently combined with peripheral stem cell mobilization and a consolidation chemotherapy regimen.

Anonymous Patient Answer

How serious can multiple myeloma be?

Survival and progression-free survival are not predictive of progression-free survival as a endpoint in IMiD-treated MM. Patients are unlikely to benefit from IMiD therapy if they have detectable myeloma plasma cells or disease that is in the symptomatic stage.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

In the present population-based study of 1045 MM patients, [myeloma-free survival, clinical stage, and treatment were the most significant prognostic factors that were significantly associated with risk of death] (http://www.european-medicine.info/content.cfm?tid=638). All of these were significant prognostic factors for overall survival, irrespective of age or disease duration.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

The primary spread of MM is, at present, through hematogenous spread from bone lesions (osseous), which is likely due to the blood-testis barrier disrupting normal hematopoiesis to cause spread throughout the blood stream via the lymphatic drainage system. There is also evidence that MM in bone marrow may be able to escape hematogenous barriers and spread via the bloodstream. While the precise mechanisms of MM spreading remain unclear, current research efforts aim at developing novel and effective treatments to impede these processes.

Anonymous Patient Answer

How does total marrow irradiation work?

Despite the dramatic differences between different studies in the use of TBI in patients with MM, few patients are left with disease-free disease following TBI therapy. Most patients will relapse following this treatment. TBI is a powerful antineoplastic therapy that provides the best survival for patients following initial treatment with myeloma medications. However, TBI therapies are accompanied by a high rate of late toxicity, most notably marrow failure. New approaches to treat this side effect are necessary to improve the benefit of TBI therapy.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

[A prospective study] involving over 4000 individuals aged 40 years and aged 65 years and over with a newly established diagnosis of multiple myeloma showed that [some people] with symptomatic multiple myeloma at the time of diagnosis had a 2·5 times greater chance of developing [myeloma] after 20 years of follow-up, as compared with the general population. [A 2008 prospective study] found [a 5 years survival rate of 5·8% for patients with symptomatic multiple myeloma; and a 12 years survival rate of 12·5% for those with newly diagnosed, asymptomatic disease.

Anonymous Patient Answer

Does multiple myeloma run in families?

The prevalence of MM in families with MM is similar to the prevalence of MM in patients with MM. A possible clue that the familial occurrence of MM is hereditary is a report by some of the first families in which a parent (father) with MM had spawned at least two affected sons within a relatively short period.

Anonymous Patient Answer
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