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Prophylactic Tocilizumab to Prevent Cytokine Release Syndrome in Relapsed/Refractory Multiple Myeloma Patients Receiving JNJ-79635322 and Human Normal Immunoglobulin (IV)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on a type of blood cancer called Multiple Myeloma that has returned or does not respond to earlier treatments. A known complication of the therapy used for this condition is a rapid immune reaction called Cytokine Release Syndrome, which can cause fever, low blood pressure, and breathing problems.

The purpose of the study is to determine whether giving a single dose of Tocilizumab before the cancer drug ramantamig can lower the chance of this immune reaction compared with a placebo. Participants are randomly assigned to receive either the active medication or the inactive solution, and neither the medical team nor the participants know which one is given. After the injection, participants receive the cancer treatment and are observed for about four weeks for any signs of the immune reaction or other side effects.

The trial follows a double‑blind design, meaning the assignment is concealed, and it lasts until the end of the monitoring period after the first dose of the cancer drug. Safety checks, blood tests, and regular visits are used to record any problems that arise during the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and receipt of study medication
After you consent to join the study, you will be randomly assigned to receive either tocilizumab or a matching placebo. the assignment is done by the study staff and you will not know which one you receive.
The study medication is prepared for intravenous infusion, which means it will be delivered through a vein.
Step 2
Intravenous infusion of tocilizumab or placebo
You will receive a single intravenous infusion of tocilizumab (or placebo) before any other study drug is given. the infusion is administered in a clinic setting and lasts for a short period of time.
The exact amount of the drug is defined by the study protocol; it is given only once, on the day of randomization.
Step 3
Subcutaneous administration of ramantamig
Following the infusion, you will receive the investigational drug ramantamig by subcutaneous injection, which means the medication is placed just under the skin.
The first dose may be a step‑up dose, after which additional doses are given according to the study schedule. the frequency and total duration are defined by the protocol and are followed for the remainder of the treatment period.
Step 4
Monitoring for cytokine release syndrome
After the ramantamig dose, you will be observed for signs of cytokine release syndrome (crs), a condition where the immune system becomes over‑active.
Monitoring includes clinic visits, vital‑sign checks, and laboratory tests. this monitoring continues for at least 28 days from the day of the ramantamig step‑up dose.
Step 5
Regular safety and efficacy assessments
Throughout the 28‑day monitoring period, you will have scheduled visits or phone contacts to record any side effects, infections, or changes in blood counts.
The study team will also evaluate your response to treatment using standard criteria for multiple myeloma.
Step 6
Final study visit at day 28
On day 28 after the ramantamig step‑up dose, you will attend a final visit where all remaining assessments are completed.
The data collected at this visit are used to determine whether the prophylactic use of tocilizumab reduced the occurrence of crs compared with placebo.

Who can join the trial?

5 criteria

You must have a confirmed diagnosis of Multiple Myeloma that meets the International Myeloma Working Group (IMWG) diagnostic criteria and show measurable disease, which means one of the following lab results: a blood test showing M‑protein level at least 0.5 g/dL, or a blood test showing free light chain (FLC) level at least 10 mg/dL with an abnormal kappa/lambda ratio, or a urine test showing M‑protein at least 200 mg in a 24‑hour collection.
You must have received at least one previous line of therapy (treatment) for your myeloma.
Your disease must be either relapsed (it got better with earlier treatment but then got worse again, confirmed by standard criteria more than 60 days after stopping the previous treatment) or refractory (it never responded well to prior treatment or got worse again within 60 days after stopping that treatment).
You need an ECOG performance status score of 0 to 2 at screening and before starting the study drug. This score rates how well you can carry out daily activities, where 0 means fully active and 2 means up and about more than 50% of waking hours. Participants with a score of 2 or 3 may be eligible if the limitation is stable and not caused by myeloma or its treatment.
You must be an adult (the study includes the adult age groups) and can be either male or female.

Who cannot join the trial?

9 criteria

Concurrent use of other anticancer treatment: You cannot be taking any other cancer therapy, including non‑palliative radiation or experimental drugs. If you have had an allogeneic stem cell transplant (a transplant from another person), it must have been at least 6 months ago, you must have stopped all medicines that suppress the immune system for at least 6 weeks, and you must have no signs of graft‑versus‑host disease (where the new immune cells attack your body). Any side effects from previous cancer treatment must have improved to a mild level (called Grade 1 or better), except for hair loss, skin changes, dry mouth, hearing loss, hormone problems that are being treated, or nerve problems, which may be a little more severe (up to Grade 2).
Serious underlying medical conditions:
- a. Active infection (viral, fungal, or bacterial) that needs medication.
- b. Active autoimmune disease (where the immune system attacks the body) that required strong immune‑suppressing medicines within the past 6 months. Exceptions are vitiligo, type 1 diabetes, or past autoimmune thyroid disease that is currently normal.
- c. Clear evidence of dementia or altered mental status.
- d. Major heart or blood‑vessel problems in the past 6 months, such as severe or unstable chest pain (unstable angina), heart attack (myocardial infarction), seizure, major blood clots (e.g., pulmonary embolism, stroke), serious heart rhythm problems (ventricular arrhythmias), or advanced heart failure (classified as New York Heart Association Class III‑IV). A simple deep‑vein clot is allowed.
- Other cancers that exclude participation:
  - a. Ongoing myelodysplastic syndrome (a blood disorder) or any B‑cell cancer other than multiple myeloma.
  - b. A past cancer (other than multiple myeloma) considered high risk of returning and needing systemic therapy (treatment that affects the whole body).
  - c. An active cancer (other than multiple myeloma) that is high risk of recurrence and requires systemic therapy, except for certain low‑risk cancers such as specific non‑muscle‑invasive bladder cancers, non‑melanoma skin cancers, non‑invasive cervical cancer, certain early‑stage breast or prostate cancers, or cancers that are judged to be cured with minimal risk of return.
  - Central nervous system (CNS) involvement: You cannot have active or past involvement of the brain or spinal fluid by multiple myeloma, or any signs that it may be affecting the meninges (the covering of the brain). If this is suspected, a brain MRI and spinal fluid test must be negative.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Alexandra Hospital
Verified
Athens, Greece
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Semmelweis University
Responsive
Budapest, Hungary

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Investigated drugs

Tocilizumab
is given through an IV line. It works by blocking a protein called interleukin‑6 that can cause strong inflammation. In this study it is used before the cancer drug is given to try to stop a sudden, intense immune reaction called cytokine release syndrome.
JNJ-79635322
is an experimental medicine given as a subcutaneous injection. It is a special type of antibody that can attach to three different targets: a T‑cell receptor (CD3), a protein on myeloma cells (BCMA), and another cell‑surface receptor (GPRC5D). By linking immune cells to the cancer cells, it helps the body’s immune system find and kill the myeloma cells. This drug is being tested as a new treatment for multiple myeloma.
Human normal immunoglobulin (IV)
is a preparation of antibodies taken from many healthy donors and given through an IV. It provides a broad supply of immune proteins that can help protect the body’s defenses, especially when a patient’s own immune system is weakened.

What is already known about the treatment

Tocilizumab
This medication is given by intravenous infusion. It is already approved for conditions such as rheumatoid arthritis and cytokine release syndrome, and is being tested to prevent CRS in multiple myeloma patients. It works by blocking the interleukin‑6 receptor, which reduces inflammation. It belongs to the class of interleukin‑6 receptor antagonists.
JNJ‑79635322
This experimental drug is administered as a subcutaneous injection. It is not yet approved and is being studied for relapsed/refractory multiple myeloma. The antibody is designed to attach to three targets – CD3 on T‑cells, BCMA on B‑cells, and GPRC5D – helping the immune system recognize and kill cancer cells. It is classified as a trispecific monoclonal antibody.
Human normal immunoglobulin (IV)
This product is given by intravenous infusion. It is a widely used preparation that provides a broad mix of antibodies for people with immune deficiencies or certain infections. It works by supplying the body with antibodies that can help fight germs. It belongs to the class of immune‑globulin preparations.
Placebo
This control solution is given by intravenous infusion. It contains only an inert fluid and no active drug, serving as a comparison for the active treatments. It is classified as an intravenous solution additive.

Investigated diseases

Relapsed/refractory multiple myeloma - Multiple myeloma is a cancer that starts in the plasma cells of the bone marrow. When it is relapsed or refractory, the disease has returned after previous treatment or does not respond to therapy. Abnormal plasma cells continue to grow and replace normal marrow, leading to weaker bones, low blood counts, and kidney problems. The condition can spread within the marrow, causing increasing fatigue, bone pain, and susceptibility to infections. Over time, the amount of cancer‑produced protein in the blood may rise, reflecting disease activity.