Study of Linvoseltamab in Adults with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called relapsed or refractory multiple myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study is testing a new treatment called REGN5458, which is a special type of medication known as a bispecific antibody. This medication is designed to target specific proteins on cancer cells to help the immune system fight the cancer more effectively.

The purpose of the study is to evaluate the safety and effectiveness of REGN5458 in patients with multiple myeloma who have already tried other treatments. The study is divided into two phases. In the first phase, the medication is given through an intravenous (IV) infusion to find the best dose that patients can tolerate. In the second phase, the study looks at how well the medication works in controlling the cancer. Some patients may also receive a pre-treatment with a medication that targets a protein called IL-6R to help manage side effects.

Throughout the study, participants will receive either the new treatment or a placebo. The study will monitor the participants’ response to the treatment, including any side effects they may experience. The goal is to determine if REGN5458 can be a safe and effective option for treating relapsed or refractory multiple myeloma. The study will continue until the researchers have enough information to make a conclusion about the treatment’s effectiveness and safety.

1 initial treatment phase

Upon joining the study, the initial treatment involves receiving dexamethasone sodium phosphate as a 4 mg/ml solution for injection or infusion. This is administered through an intravenous (IV) infusion.

The purpose of this phase is to prepare the body for the main treatment and to assess initial reactions to the medication.

2 main treatment phase

The main treatment involves the administration of linvoseltamab, a solution for injection. This is given as a solution for infusion.

The treatment is designed to target specific proteins associated with multiple myeloma, aiming to reduce the progression of the disease.

3 supportive care

During the trial, supportive care includes taking diphenhydramine hydrochloride 25 mg tablets orally. This medication helps manage potential allergic reactions.

Additionally, paracetamol 500 mg film-coated tablets are taken orally to manage any pain or fever that may occur during the treatment.

4 monitoring and assessment

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any adverse effects and measuring the response to the medication.

The study aims to determine the optimal dosage and to evaluate the overall response rate to the treatment.

5 conclusion of treatment

At the end of the treatment phase, a final assessment is conducted to evaluate the overall impact of the treatment on the disease.

The results are used to determine the potential for future use of the medication in treating relapsed or refractory multiple myeloma.

Who Can Join the Study?

Patients must have a confirmed diagnosis of active Multiple Myeloma, a type of blood cancer.
Patients should have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but can still do light work.
The myeloma must be measurable according to specific criteria set by experts in the field.
For Phase 1, Part 1: Patients must have tried all available treatments that could help, and their disease must have worsened after at least 3 different treatments, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 antibody, or they must not have responded to these treatments.
For Phase 1, Part 2: Patients must have tried at least 3 different treatments, including a PI, an IMiD, and an anti-CD38 antibody, or they must not have responded to these treatments.
For Phase 2, Cohorts 1 and 2: Patients must have tried at least 3 different treatments, including a PI, an IMiD, and an anti-CD38 antibody, or they must not have responded to these treatments.
For Phase 2, Cohort 3: Patients must have tried at least 3 different treatments, including a PI, an IMiD, and an anti-CD38 antibody, or they must not have responded to these treatments.
If patients have relapsed after receiving BCMA-directed CAR-T cellular therapy, a type of treatment that uses modified immune cells, they must have shown some improvement from this therapy, and it must have been at least 60 days since they received it.
Other specific criteria defined in the study protocol may also apply.
Both male and female patients are eligible to participate.
Patients must be adults, as the study includes age ranges for adults only.

Who Cannot Join the Study?

Patients who have not experienced a return of their disease or whose disease has not stopped responding to treatment.
Patients who have not tried at least three different treatments for their condition.
Patients who are not resistant to three specific types of treatments: a proteasome inhibitor (a drug that blocks the action of proteasomes, which are part of the cell’s machinery for breaking down proteins), an immunomodulatory imide drug (IMiD) (a drug that modifies the immune system), and an anti-CD38 monoclonal antibody (a type of drug that targets a specific protein on the surface of certain cells).
Patients who have not previously relapsed after receiving BCMA directed chimeric antigen receptor (CAR)-T cellular therapy (a treatment that uses modified immune cells to target cancer cells).
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Hoccqldq Uezrkwqednono Dw Ln Ptjxofdi	Madrid	Spain
Ckvihnvtf Ujnveexnstpqws Skxdlpxcb	Woluwe-Saint-Lambert	Belgium
Hfolhpbo Du Ln Swmkh Cgsf I Sizd Pbt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	23.01.2019
Spain	Recruiting	23.01.2019

Trial locations

Investigated drugs:

REGN5458 is a bispecific antibody designed to target two specific proteins: BCMA and CD3. It is being studied as a treatment for patients with multiple myeloma that has returned or is not responding to other treatments. The trial is exploring how safe and tolerable this medication is when given either intravenously or subcutaneously, and aims to find the best dosing regimen for future studies.

Anti-IL-6R is a pre-treatment used in the trial to help prevent a side effect known as cytokine release syndrome (CRS) in patients receiving REGN5458. This therapy works by blocking the IL-6 receptor, which is involved in the inflammatory response that can lead to CRS. The study is assessing whether this pre-treatment can improve the safety and effectiveness of REGN5458 in patients who have already tried other treatments without success.

Relapsed or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease returns after treatment or does not respond to standard therapies. It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease is characterized by the uncontrolled growth of abnormal plasma cells, leading to a decrease in the production of normal blood cells. Over time, this can result in complications like anemia, bone fractures, and kidney problems.

Trial ID:

2024-511454-45-00

Protocol code:

R5458-ONC-1826

NCT ID:

NCT03761108

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Linvoseltamab in Adults with Relapsed or Refractory Multiple Myeloma

What is this study about?

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