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

2 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
Hospital Universitario De Leon	Leon	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Le Mans	Le Mans	France
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Semmelweis University	Budapest	Hungary
Karolinska University Hospital	Solna	Sweden
Fktsqjpsj Pqqm Lv Iwedhgwkyzbwn Bptedmndd Dsy Hfszzzzb Uuesnrasqjjvb Lr Pxd	Madrid	Spain
Hnfetmgh Urnllmmwrctvy Dr Pbsng Apfyixqzkr	Valencia	Spain
Hwspjhyo Dh Lg Smdqg Cdml I Show Prg	Barcelona	Spain
Cmttlq Hlqzqvcilne Iftdrrerewgwx Da Cyfnzyggylu	Quimper	France
Cyjqvf Hnpzvhewlxo Dw Ly Cwid Bmcssv	Bayonne	France
Ceirsl Hverkgbvhmr Vsmgfy Dbjozz	Argenteuil	France
Mvxtic Cyfwkw Cxvgny Hazbabpu Oe Porajbo	Piraeus	Greece
Ubqiopytee Gxmdgcq Htjvncio Op Arjomoobgylmzq	Alexandroupoli	Greece
Apvmxaktz Hfaxmert	Athens	Greece
2rr Awf Frxsj Gkhemiw Hdkpovsy	Athens	Greece
Hspjnoaatfvs Hddvonuq	Athens	Greece
Tyxjgreain Csrcdz Htsdruhn	Thessaloniki	Greece
Gawzzzo Uopfebytvk Hwnvxvzr Oy Pjfygu	Patras	Greece
Cmuw Cvbmdj Cvddsmy Afxqsnomp Bwxlf Alcnapxdek	Braga	Portugal
Hmtexfjh Cat Dyhijkqekdk Svqg	Lisbon	Portugal
Cntjah Hkopaohkyu Ulzqicuzrifup Dg Szemj Anqymfj Ekktrx	Porto	Portugal
Uimaejp Lmqiw Di Sskxh Dh Gpuigpzuaxkt Ezfthw	Vila Nova De Gaia	Portugal
Ohzfkfcr Oaqtecrogg Itnvokw	Budapest	Hungary
Uncdomsxnc Od Sghuuo	Szeged	Hungary
Uiakbwlkpm Op Dkharehi	Debrecen	Hungary
Ujgvikyjtl On Perq	Pecs	Hungary
Rsombf Dvprduu	Falun	Sweden
Qycmy Smusoc Cwowduuml Hceulmvi &uyvczo Svjtsgezpoh Uawsmdgnei Hqbxalkj &bzekvc Vlkwnyw Gpavszlzznwzmivneh	Gothenburg	Sweden
Roymvd Sbtjd Sytnko Uswhfnvlexwohjnstqu	Lund	Sweden
Ufabddo Ugedffgzap Hqtfeivh	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	09.08.2026
Greece	Not yet recruiting	09.08.2026
Hungary	Not yet recruiting	09.08.2026
Portugal	Not yet recruiting	09.08.2026
Spain	Not yet recruiting	09.08.2026
Sweden	Not yet recruiting	09.08.2026

Trial locations

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.

Investigated Diseases:

Plasma cell myeloma refractory

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.

Trial ID:

2025-524793-42-00

Protocol code:

79635322MMY2002

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?