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JNJ-79635322 versus Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma After at Least 3 Prior Treatments

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What is this trial about?

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

This study is being done in Relapsed or Refractory Multiple Myeloma, a type of blood cancer that has come back or has not responded well to past treatment. The study compares JNJ-79635322 with teclistamab, which are both given as injections under the skin. The purpose of the study is to see which treatment works better for people with this disease.

Participants are assigned to one of the study treatments and receive injections over time during regular study visits. The study team follows how the cancer responds and watches for side effects and other health changes. It also looks at how long the treatment effects last and how the treatments affect daily well-being and symptoms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the study
You join a phase 3 randomized study for people with relapsed or refractory multiple myeloma. This means the cancer has come back or has not responded well to treatment.
You are assigned to receive one of the study treatments by chance. The study compares JNJ-79635322 with an anti-bcmaxcd3 bispecific antibody. A bispecific antibody is a treatment designed to attach to two different targets.
The study treatment is given by subcutaneous use, which means it is injected under the skin.
The medicine listed for the study is teclistamab or JNJ-79635322. The source data does not provide a dose, frequency, or duration of administration, so those details are not specified here.
Step 2
During treatment
You receive the assigned study medicine by subcutaneous injection during the trial.
The trial measures how well the treatment works by looking at overall response rate, which means how many people have their cancer shrink or improve, and progression-free survival, which means the length of time before the disease gets worse.
The trial also checks other results, including how long the response lasts, whether there is a very strong response called complete response, and whether there are no signs of disease using a test called mrD or minimal residual disease. This means checking for very small amounts of cancer that may remain after treatment.
Step 3
Safety checks and tests
During the trial, your safety is monitored. The study records side effects, including how often they happen and how severe they are.
The study also checks laboratory results, which are test results from blood or other samples.
The study measures the amount of JNJ-79635322 in your blood, if you receive that treatment.
The study checks for adas, which are antidrug antibodies. These are proteins your body may make against the study medicine. It also checks for neutralizing antibodies, which can block the medicine from working.
Step 4
Questionnaires during the study
You complete questionnaires about how you feel during the trial.
These questionnaires measure quality of life, symptoms, and how well you are able to function in daily life.
The study uses the mysim-q, eortc qlq-c30, and eq-5d-5l. These are forms that ask about symptoms, daily activities, and general health.
The study also checks how much of a burden the side effects feel like using the eortc il46 questionnaire.
Step 5
Follow-up of study outcomes
The study continues to track whether the cancer gets worse again after treatment, whether a response lasts, and whether treatment leads to better disease control over time.
It also looks at overall survival, which means how long people live during the study period, and time to next treatment, which means how long it takes before another cancer treatment is needed.
The study period is planned to run from 2026-05-14 to 2031-09-30.

Who can join the trial?

29 criteria

Be an adult at the time of signing consent, meaning 18 years or older, or at least the legal adult age in the place where the study is done.
Have a confirmed diagnosis of multiple myeloma based on the study’s required medical criteria.
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Have measurable disease at screening, meaning there must be enough disease markers in blood or urine to measure, such as:
- Serum M-protein of at least 0.5 g/dL in blood.
- Serum free light chains of at least 10 mg/dL with an abnormal kappa/lambda ratio. Free light chains are small protein pieces made by plasma cells.
- Urine M-protein of at least 200 mg/24 hours in urine collected over 24 hours.
- Have already received at least 3 earlier lines of treatment for multiple myeloma. A line of treatment means a course of therapy given for the disease.
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  Have previously received all of the following types of treatment:
  - A proteasome inhibitor (a medicine that blocks a cell protein system used by cancer cells).
  - An IMiD, which means an immunomodulatory drug that helps the immune system fight the disease.
  - An anti-CD38 antibody, which is a medicine that targets a protein called CD38 on myeloma cells.
  - Have relapsed or refractory disease, meaning the disease came back after treatment or did not respond well enough to the last treatment. A partial response or better means the disease improved enough to count as a response.
  - Have stopped any other cancer treatment, including non-curative radiation therapy, and stopped any other experimental treatment.
  - Have side effects from earlier cancer treatment that have improved to Grade 1 or better, except for certain long-lasting effects that are allowed if they are Grade 2 or better. Grade means how severe a side effect is, with higher numbers meaning worse symptoms.
  - Have an ECOG performance status of 0 to 2 at screening and right before treatment starts. This is a measure of how well a person can do daily activities.
  - Have kidney function with an eGFR greater than 30 mL/min. eGFR is an estimate of how well the kidneys filter blood.
  - Have liver test results within the allowed range during screening and within 1 day before treatment starts:
    
    AST less than 2.5 times the upper limit of normal. AST is a liver enzyme.
    ALT less than 2.5 times the upper limit of normal. ALT is another liver enzyme.
    Total bilirubin less than 1.5 times the upper limit of normal. Bilirubin is a substance made when the body breaks down red blood cells.
    If the person has Gilbert’s syndrome, a harmless inherited condition that can raise bilirubin, the test rules above may be different as described in the study.
    Have blood test results within the allowed range during screening and within 1 day before treatment starts:
    
    Hemoglobin of at least 7.5 g/dL, without a blood transfusion or growth factor medicine in the previous 7 days. Hemoglobin is the part of blood that carries oxygen.
    Neutrophils of at least 0.75 x 10^3/μL, with the required time off certain growth factor medicines before the test. Neutrophils are a type of white blood cell that helps fight infection.
    Platelets of at least 50 x 10^3/μL, without a transfusion or growth factor medicine in the previous 7 days. Platelets help blood clot.
    Agree to follow the pregnancy, breastfeeding, contraception, and donation rules during the study treatment and for 6 months after the last dose:
    
    Do not be pregnant or breastfeed.
    Do not donate eggs or sperm, and do not freeze them for future assisted reproduction.
    If sperm or semen can be passed to a partner, use an external condom.
    If the participant can become pregnant, have a negative pregnancy test at screening and within 24 hours before the first dose, and have further pregnancy tests as required.
    If the participant can become pregnant, use at least one highly effective birth control method. If oral birth control pills are used, a barrier method such as a condom must also be used.
    If the participant can produce sperm and their partner can become pregnant, the partner must also use a highly effective birth control method.
    Be willing and able to follow all lifestyle restrictions in the study plan.
    Give informed consent, meaning the person understands the study and agrees to take part by signing the consent form.

Who cannot join the trial?

21 criteria

Any serious medical condition that could make the study unsafe, including an active infection that needs treatment with antiviral, antifungal, or antibiotic medicine and is still clinically important at the time of the first dose.
Any active autoimmune disease that needed systemic immunosuppressive therapy within the past 6 months. An autoimmune disease is when the immune system attacks the body’s own tissues. Exceptions: vitiligo, type 1 diabetes, or past autoimmune thyroiditis that is now normal are allowed.
Clear signs of dementia or altered mental status, meaning confusion or a major change in thinking or awareness.
Within the past 6 months: severe or unstable chest pain (angina), heart attack, seizure, major blood clot such as a pulmonary embolism, stroke, or TIA (a short-lived stroke-like event), serious irregular heart rhythms, or heart failure that limits normal activity to class III or IV.
Active hepatitis from infection, including hepatitis B with a positive HBsAg test, or hepatitis B with detectable HBV-DNA on confirmatory testing. HBsAg is a blood test showing current hepatitis B infection. People with only vaccine-related antibodies are not excluded.
Hepatitis C infection, or a positive hepatitis C antibody test unless a follow-up hepatitis C RNA test is negative, showing no active virus.
Other active infectious liver disease.
HIV-positive patients who have any of the following: detectable virus in the blood, CD4 count of 300 cells/mm3 or less, an AIDS-defining opportunistic infection within 6 months, or a change to HIV treatment that is not allowed by the study rules. CD4 count is a measure of immune cells.
Plasma cell leukemia at screening, or a diagnosis of Waldenström’s macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
Known or suspected central nervous system involvement by the cancer, or signs that the cancer may involve the meninges, which are the coverings around the brain and spinal cord.
Another active blood cancer, such as myelodysplastic syndrome or a B-cell malignancy other than the study disease.
A past cancer, other than the study disease, that has a high risk of coming back and would need systemic treatment. Some very low-risk or cured cancers are allowed, as listed in the study rules.
Known or suspected allergy, hypersensitivity, or intolerance to JNJ-79635322 or any of its ingredients.
Major surgery within 2 weeks before the first dose, not fully recovered from surgery, or surgery planned during the study period. Surgery under local anesthesia is allowed.
Known or suspected allergy, hypersensitivity, or intolerance to teclistamab or any of its ingredients.
Previous or current treatment with certain immune-based cancer therapies within the required time limits, including CAR-T or a bispecific antibody within 6 months, prior treatment with both BCMA- and GPRC5D-targeted therapy, or prior treatment with a BCMA-directed bispecific antibody.
An allogeneic stem cell transplant within 6 months before treatment, or not being off immunosuppressive medicines for at least 6 weeks, or having signs of graft-versus-host disease. An allogeneic transplant uses stem cells from another person, and graft-versus-host disease means the donated cells attack the body.
A high dose of corticosteroids in the 14 days before the first dose, equal to 140 mg or more of prednisone. Corticosteroids are anti-inflammatory medicines.
Recent use of another investigational drug, investigational treatment, investigational vaccine, or an invasive investigational medical device within 28 days or within 5 half-lives of that treatment, whichever is longer. Investigational means not yet approved for routine use.
Receiving, planning to receive, or having received a live, weakened vaccine within 4 weeks before treatment, during treatment, or within 90 days after the last dose. Live vaccines are not allowed because they contain a small amount of live germ.
Any other condition that, in the investigator’s judgment, would not be in the patient’s best interest or could make study results harder to interpret.

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Verified sites

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Akershus University Hospital
Lorenskog, Norway
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

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Investigated drugs

teclistamab
This is a medicine given under the skin that helps the immune system attack myeloma cells. It is a type of bispecific antibody that brings T cells, which are part of the body’s defense system, close to the cancer cells so they can be destroyed.
JNJ-79635322
This is an experimental medicine given under the skin in the study. It is designed to help the immune system find and kill myeloma cells by linking T cells to targets on the cancer cells. The trial is testing how well it works compared with another similar immune-based medicine.

What is already known about the treatment

teclistamab
Teclistamab is given as a solution for injection under the skin, so it is administered by subcutaneous injection. It is an approved medicine in some countries and is also widely discussed in medical literature as a treatment for relapsed or hard-to-treat multiple myeloma. It is a bispecific antibody that binds to BCMA on myeloma cells and CD3 on T cells, bringing these cells together so the immune system can attack the cancer cells; it is used mainly for relapsed or refractory multiple myeloma after other treatments have failed.
JNJ-79635322
JNJ-79635322 is given as a solution for injection under the skin, using subcutaneous administration. It is an investigational medicine in clinical trials and is not yet a standard approved treatment in routine medical practice, although it is being studied closely in medical literature for multiple myeloma. It is a trispecific monoclonal antibody that targets CD3 on T cells, BCMA on myeloma cells, and GPRC5D on myeloma cells, helping immune cells find and kill the cancer; it belongs to the class of immune-based antibodies for relapsed or refractory multiple myeloma.

Investigated diseases

Relapsed or Refractory Multiple Myeloma - A form of multiple myeloma in which abnormal plasma cells return after treatment or no longer respond well to treatment. It usually begins in the bone marrow and can gradually spread within the bones and other parts of the body. As it progresses, the number of abnormal plasma cells increases and can crowd out normal blood-forming cells. This can lead to worsening bone damage, anemia, and higher levels of abnormal protein in the blood or urine.