Tiragolumab for Multiple Myeloma
This study is evaluating whether tiragolumab may be effective in treating multiple myeloma and non-Hodgkin lymphoma.
See full descriptionAbout the trial for Multiple Myeloma
Treatment Groups
This trial involves 5 different treatments. Tiragolumab is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Multiple Myeloma or one of the other 6 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Tiragolumab will improve 1 primary outcome and 7 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Cycles 1, 2, 4, 8, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years).
Patient Q & A Section
Can multiple myeloma be cured?
Patients with stable or minimal myeloma respond well to treatment. Patients with progression/relapse after first-line treatment have poor prognosis and are more likely to develop myeloma-related complications.
What are the signs of multiple myeloma?
The signs of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) typically appear over weeks and months. An increase in circulating blood cells, enlargement of the spleen or lymphomas (both lymphocytic and plasmacytic) should be investigated. The main signs of multiple myeloma are anemia, a low platelet count, anemia of bone marrow or a palpable bone mass. It is necessary to detect myeloma on the basis of symptoms, medical history, and laboratory testing. The main signs of monoclonal gammopathy include the presence of a serum paraprotein and/or plasmacytic, plasma and/or lymphocyte hypersecretion.
What causes multiple myeloma?
Most cases of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) have no known cause. Those with known causes tend to have a longer disease-free interval before developing overt signs and symptoms of the disease, and more bone lesions (radiological evidence of excessive bone destruction) on X-ray when surveyed and are more likely to have plasma cell dyscrasia. These factors suggest that an unknown cause, which can lead to the onset of myeloma in a minority of cases, may contribute to the disease. This view is supported by research showing that a large proportion of cases have abnormalities in their genes that can cause multiple myeloma in families, but not in the general population, who have no family history of multiple myeloma.
What are common treatments for multiple myeloma?
Atypical multiple myeloma patients are often pretreated with one or more corticosteroids. This is followed by therapy with one of the following: Bortezomib, bortezomib plus dexamethasone, or chlorambucil. A majority of older patients who have not responded to bortezomib and bortezomib-plus-dexamethasone are admitted to the intensive care unit for the development of encephalopathy from dexamethasone. In younger patients, autotransplantation is the preferred primary treatment, although bone marrow transplantation may be indicated for patients with high-risk or bulky disease.
What is multiple myeloma?
If myeloma is suspected, the diagnosis is confirmed by a bone scan and measurement of the levels of calcium and creatinine at different points in time. Plasma cell myeloma is more common in Asian and African-American men, multiple myeloma accounts for only 4% of all renal and hematologic malignancies. It is associated with an increased risk of non-Hodgkin-cell lymphoma (NHL), especially chronic lymphocytic leukemia. In patients with multiple myeloma, a serum paraprotein level may be detected in 40-60% of cases and may reflect a specific serum monoclonal protein. The most common paraprotein isoform is IgG lambda.
How many people get multiple myeloma a year in the United States?
About 30,800 people are diagnosed as having multiple myeloma each year. One case every seven million of these cases will be one of those who has multiple myeloma that is due to a nondiagnosis. It is not surprising that these numbers show a large number, because multiple myeloma patients are seldom seen at regular check ups.
What are the common side effects of tiragolumab?
Common side effects of nivolumab included hypersensitivity reactions, headache, back pain, fatigue, nausea, diarrhea, constipation, vomiting, and upper respiratory infections. The majority of hypersensitivity reactions were transient, and the majority of patients receiving nivolumab were able to taper down their dose or discontinue therapy over months to years. If hypersensitivity reactions remain, treatment is usually not necessary and the nivolumab can be restarted.
Who should consider clinical trials for multiple myeloma?
Physicians should consider clinical trial eligibility for all patients with multiple myeloma and those with high-risk relapsed/refractory multiple myeloma in whom (1) the risk of disease progression is relatively low (<24 months), (2) the risk of treatment-related death is relatively low (<45 days), and (3) the risk of therapy-associated amyloidosis is low (<15%). Clinical trials for elderly patients with high risk of death (median not-apparent life expectancy <18 weeks) should be performed on a case-by-case (but not a case by case) basis.
What is tiragolumab?
Tiragolumab is a human monoclonal antibody against PD-L1 that inhibits PD-1 expression, inducing a state of anergy (cellular and humoral) in T cells. Tiragolumab is currently in clinical trials as a multiple myeloma-specific antibody. It can induce regression in multiple myeloma patients, resulting in a significant increase in the average progression free survival of patients (from 17% in the placebo group to 40% in the tiragolumab group). Many patients reported side effects in clinical trials, including diarrhea, fatigue, rash and infusion site reaction, including flushing.
What are the chances of developing multiple myeloma?
The current study shows that multiple myeloma can be a rare disorder. Furthermore, it was revealed that multiple myeloma has an increased trend to present to later stages in life as compared to those patients with non-cancerous plasma cell disorders such as monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. However, the average age at multiple myeloma diagnosis was lower than the age of patients with non-cancerous plasma cell disorders. Findings from a recent study need further study to discover whether cancer-related environmental factors or environmental factors that are present in multiple myeloma patients increase their chances of developing leukemia.
What is the survival rate for multiple myeloma?
Multiple myeloma affects about 1.6% of the U.S. population every year. However, the survival rate for multiple myeloma appears to be good and inversely correlates with the age of the patient.
What does tiragolumab usually treat?
In this retrospective analysis of a diverse sample of clinical trials from a specialty-driven observational database, the majority of patients with MM received therapy with TGN1412. Thus, clinical trial participants may be representative of what patients with MM usually get treated.