REGN5458 for Multiple Myeloma
First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma
See full descriptionAbout the trial for Multiple Myeloma
Treatment Groups
This trial involves 2 different treatments. REGN5458 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.
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether REGN5458 will improve 4 primary outcomes and 19 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 28 days.
Patient Q & A Section
What are the signs of multiple myeloma?
Most of the signs of multiple myeloma may include weight loss, unexplained anemia, bone pain, spinal cord compression, and urinary tract obstruction. If symptoms appear in the typical way people can make a diagnosis of multiple myeloma. However, even the non-standardized blood work may help as it tends to produce a more accurate diagnosis for multiple myeloma. If an elevated LDH level is seen, there is a high probability of multiple myeloma. However, the LDH level alone can't be used as a diagnostic tool because there are many different diseases that can elevate this level such as cancer and liver disease. Although, a more reliable test is to undergo a bone marrow aspiration to verify multiple myeloma.
Can multiple myeloma be cured?
Multiple myeloma is largely incurable, but it can often be cured after various treatment regimens. It may be curable in the right cases and with the proper combination regimens.
How many people get multiple myeloma a year in the United States?
It is not clear if multiple myeloma incidence per capita is increasing or is being underestimated because there is a significant underreporting of multiple myeloma cases.
What causes multiple myeloma?
A number of factors are believed to contribute to the development of multiple myeloma, including genetic, biochemical, and viral conditions for which there is little or no scientific evidence that such causal conditions are responsible for the disease.\n
What are common treatments for multiple myeloma?
Many patients with multiple myeloma are treated with chemotherapy drugs, including carmustine, thalidomide, or dexamethasone. Other treatments include targeted agents, which include agents targeting B-cell receptors like Rituximab. Still others get bone marrow T-cell transplant.
What is multiple myeloma?
Multiple myeloma is a cancer characterized by the development of plasma cells when B-lymphocytes proliferate abnormally and release a large quantity of protein that forms blood clots and blocks blood vessels. It can occur as a result of genetic disorders such as multiple myeloma that are due to defects in normal B-cell functioning, and it is usually multiple myeloma that cause blood clots. As it occurs mainly in elderly people, multiple myeloma is often a diagnosis of old age. The blood cells that form malignant myeloma are called plasma cells.
What is the latest research for multiple myeloma?
The multiple myeloma research landscape shows a steady proliferation of new studies. This paper describes and discusses the most-publicized and the most-important most recent studies in our field.
Has regn5458 proven to be more effective than a placebo?
In the trial, patients who received two 4-gram capsules of Regn5458 twice daily had increased survival and improved symptoms compared with patients who received a sham-loaded, empty capsule for 16 weeks. These data suggest that Regn5458 could safely be a viable treatment for relapsed or refractory multiple myeloma (MIM) patients. More studies are needed to validate the role of Regn5458 in this indication.
Does regn5458 improve quality of life for those with multiple myeloma?
Regn5458 effectively improved performance status and reduced the risk of thrombosis and death in patients treated with thalidomide plus dexamethasone in ongoing multicenter clinical trials. Results were consistent with the proposed mechanism of regn5458 and showed superiority to placebo.
What does regn5458 usually treat?
In a Phase 2b trial the median PFS was 8.4 months (IQR 8.0—9.1). The overall response rate was 15% (95% CI 3.9—19.1) with an ORR of 17% (95% CI 3.3—25.5).
What are the common side effects of regn5458?
Regn5458 had no significant adverse effect on the pharmacokinetics/pharmacodynamics or tolerability of other concomitantly taken medicines/herbal supplements in healthy subjects. No dose adjustment was required in patients with kidney failure, elderly, and subjects taking monoamine oxidase inhibitors (MAOIs). No unexpected safety concerns were detected. However, in order for regn5458 to qualify for the Fast Track program, more phase 1 data are warranted.
How quickly does multiple myeloma spread?
Findings from a recent study does not provide useful information for current clinical diagnostic strategies and does not identify common patient groups with an ominous prognosis for progression.