CLINICAL TRIAL

REGN5458 for Multiple Myeloma

Recruiting · 18+ · All Sexes · Columbus, OH

First in Human (FIH) Study of REGN5458 in Patients With Relapsed or Refractory Multiple Myeloma

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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. 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
REGN5458
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria. show original
You have a disease that is refractory to treatment. show original
You have a performance status of 1 or 2. show original
You have a confirmed diagnosis of active MM. show original
Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment.
Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. In addition, patients must be penta-exposed (ie, having prior exposure to 2 PIs, 2 IMiDs [lenalidomide and pomalidomide], and 1 anti-CD38 monoclonal antibody).
Key
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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: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
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 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.

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
UP TO 28 DAYS
In the phase 1 portion
Change in patient-reported Global health status/QoL per EORTC QLQ-C30
BASELINE UP TO UP TO 5 YEARS
In the phase 2 portion
Change in patient-reported global health status/QoL per EORTC QLQ-C30
BASELINE UP TO UP TO 5 YEARS
In the phase 2 portion
Incidence and severity of TEAEs with REGN5458
UP TO 5 YEARS
In the phase 2 portion
Effects of REGN5458 on HRQOL and patient-reported symptoms and functioning per Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20])
UP TO 5 YEARS
In the phase 2 portion The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Effects of REGN5458 on HRQOL and patient-reported symptoms and functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
UP TO 5 YEARS
In the phase 2 portion The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
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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 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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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