Ixazomib Citrate for Plasma Cell Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Plasma Cell Myeloma+2 More
Ixazomib Citrate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of drugs may be more effective than a single drug in treating patients with newly diagnosed multiple myeloma.

See full description

Eligible Conditions

  • Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Plasma Cell Myeloma

Study Objectives

This trial is evaluating whether Ixazomib Citrate will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Plasma Cell Myeloma. Measurement will happen over the course of The time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years.

Year 2
Neurotoxicity
Year 2
Overall Survival (OS)
Year 2
Progression free survival
Up to 2 years
Incidence of adverse events
Minor Response Development (MRD)
Overall Response Rate (ORR)
Proportion of patients who achieve a confirmed Complete Response (CR)
Rate of >= Very Good Partial Response (VGPR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Plasma Cell Myeloma

Trial Design

1 Treatment Group

Treatment (ixazomib, lenalidomide, daratumumab, dexamethasone)
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. Ixazomib Citrate 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 2 and have already been tested with other people.

Treatment (ixazomib, lenalidomide, daratumumab, dexamethasone)INDUCTION PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-21. Patients receive daratumumab IV over 3-7 hours on days 1, 8, 15, and 22 of courses 1 and 2, on days 1 and 15 of courses 3, 4, and 5, and on day 1 of courses 7 and beyond. Patients also receive dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Daratumumab
FDA approved
Ixazomib
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Plasma Cell Myeloma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
(>= 0.6) The patient's serum immunoglobulin free light chain is greater than 10 mg/dL and their serum immunoglobulin kappa to lambda free light chain ratio is abnormal (>= 0.6). show original
The total bilirubin is less than 1.5 times the upper limit of normal. show original
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5 times the upper limit of the normal range. show original
The text states that the serum monoclonal protein levels is greater or equal to 1.0 g/dL. show original
A person with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 is able to carry out all of their normal activities. show original
The person has a creatinine clearance of 30 mL/min or more. show original
The patient has an absolute neutrophil count of at least 1500 cells per cubic millimeter. show original
If your platelet count is 75,000 or more per millimeter cubed, you don't need a transfusion. show original
Hemoglobin >= 8.0 g/dL
There was more than 200 mg of monoclonal protein detected in the urine in a 24-hour period by electrophoresis. show original

Patient Q&A Section

What is multiple myeloma?

"Not only may one's risk increase with age and family history, but also the severity of multiple myeloma may also result from genetics and environmental factors. To prevent, evaluate and treat, one should check if the people with high family risk, have abnormal blood screen (particularly the ALT and lactic dehydrogenase) are suspected for multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"The cause of multiple myeloma is unknown. This disease is frequently diagnosed at an advanced stage. The most common cause was a previous or current cancer; however this was not statistically different. The most likely causes were exposure to tobacco and environmental factors." - Anonymous Online Contributor

Unverified Answer

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

"Around 25,000 people could have multiple myeloma a year. Most individuals get multiple myeloma after the age of 60 years (approximately 70%). Multiple myeloma affects about 1 in 10,000 and 1 in 15,000 live in the United States currently, and most cases are not diagnosed between the ages of 20 and 40 years. Although multiple myeloma is more common in males when compared to females, women are more likely to receive multiple myeloma treatment after the age of 55 years." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Treatment of MM is often palliative and includes antimetabolite chemotherapy combinations such as bortezomib + dexamethasone, proteasome inhibitors such as bortezomib + lenalidomide, high dose corticosteroid regimens, and immunomodulatory agents such as thalidomide." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Although several treatment agents have been shown to be effective in the treatment of myeloma in the first-line/conditional/injectable-based treatments are still preferable in the case of refractory disease that is considered a hopeless disease. Long-term survival is associated with remission and overall survival. The best regimen in order to achieve this goal is unclear. However, the presence of myeloma-inhibiting monoclonal antibodies has improved outcomes in these patients." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"More than 50% of multiple myeloma patients have hypercalcaemia. This high prevalence of bone pain and bone pain-associated conditions is a relevant phenomenon. The patients' physical function and quality of life are adversely affected. The patients' condition is not worse during hospitalisation." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ixazomib citrate for therapeutic use?

"Ixazomib is safe and well tolerated for up to 12 months in patients with myeloma and has shown superiority in terms of OS and PFS compared with historical controls. Ixazomib citrate has now been licensed in Europe and the US." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple myeloma?

"The average person diagnosed with MM will die of other causes, typically from cardiovascular disease and lymphoproliferative diseases. Since most people with MM are middle aged or younger, many will not be diagnosed with MM until they reach the age of 70. Because MM is not a lifetime illness, patients and family members should anticipate that the average age of diagnosis of MM will continually rise." - Anonymous Online Contributor

Unverified Answer

What does ixazomib citrate usually treat?

"Ixazomib was effective against patients with MM and was well tolerated, with a high rate of patient satisfaction. Based on these findings, ixazomib appears to show promise as a second-line agent for MM after thalidomide or bortezomib." - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple myeloma?

"As for other MM treatments, the research is advancing at an ever faster rate. Researchers are working tirelessly on finding safe and effective new therapies for treating patients with MM. The most important advances in this area include: (1) the development of effective new drugs and novel combinations, (2) new therapeutic strategies in the use of HDT to treat MM, and (3) the development of novel non-biologic therapies by combining new drugs with previously existing therapies. In summary, recent advances in MM research provide a glimpse into not only the future of MM treatment, but also the research necessary for finding the most effective treatment options for patients with MM." - Anonymous Online Contributor

Unverified Answer

Is ixazomib citrate safe for people?

"The most common adverse effects with ixazomib citrate in people were dizziness and nausea (30% each), headache (5%), fever (5%), constipation (4%), and fatigue (3%; all ≥1%). These symptoms decreased after the first month. There were no serious adverse events; two deaths occurred; one of these was associated with a previous malignancy. Findings from a recent study is the first to assess the risk management and adverse effects of ixazomib citrate." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of multiple myeloma?

"The cause(s) of MM is a contentious issue. The available evidences are inconclusive; thus, it was not possible to definitively identify the cause(s) of the disease. A thorough systematic and conceptual characterization of MMs is lacking and no reliable biomarkers allow a prompt and effective diagnosis." - Anonymous Online Contributor

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