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Ramantamig (JNJ-79635322) with drug combination versus standard therapy in newly diagnosed multiple myeloma patients not eligible for stem cell transplant

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What is this trial about?

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

The trial involves adults with newly diagnosed Multiple Myeloma, a cancer of the bone marrow that produces abnormal plasma cells. The experimental therapy combines ramantamig, an investigational agent, with the antibody daratumumab. The comparison arms use standard regimens that include the chemotherapy drug bortezomib, the oral agent lenalidomide, and the steroid dexamethasone, either together with the antibody or without the chemotherapy.

The purpose of the study is to assess whether the new combination can prolong the period without disease worsening and increase the proportion of patients achieving a deep response after one year. Participants are randomly assigned to receive either the experimental combination or one of the standard regimens. Treatments are given by injection or oral tablets according to a schedule, and patients undergo regular clinic visits and laboratory tests to monitor disease status. The primary outcomes include PFS, defined as the time from the start of treatment until the disease shows signs of progression or the patient dies, and the 12‑month MRD-negative complete response rate, meaning no cancer cells are detectable with highly sensitive testing and the patient meets criteria for a complete response.

The study continues for several years, with follow‑up visits at defined intervals to collect information on safety and effectiveness.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After you agree to join the study, you will be assigned a random treatment group. the randomization decides whether you receive ramantamig plus daratumumab or the investigator's choice of standard therapy.

  2. Step 2

    Baseline assessments

    Before treatment starts, you will have blood tests, imaging scans, and other examinations to record your health status. these results are used to compare later changes.

  3. Step 3

    Starting study medication

    You will begin taking the medicines assigned to your group. the study drugs may include:

    ramantamig (given as a subcutaneous injection under the skin),

    daratumumab (also given as a subcutaneous injection),

    bortezomib (injected either under the skin or into a vein),

    lenalidomide (taken by mouth as a hard capsule), and

    dexamethasone (taken by mouth as a tablet).

    The exact dose, how often you take each medicine, and how long you continue are specified in the study protocol and will be explained by the study team.

  4. Step 4

    Regular clinic visits

    You will attend scheduled visits at the clinic. during each visit you will:

    Receive any required injections,

    Provide blood samples for safety and effectiveness checks,

    Report any side effects you have experienced,

    And have your doctors assess how the disease is responding.

  5. Step 5

    Continuing treatment cycles

    Treatment is given in repeated cycles according to the study plan. each cycle may last several weeks, and you will keep taking the oral medicines and receiving injections as instructed until the protocol defines the end of treatment or until your doctor decides to stop early.

  6. Step 6

    12‑month disease evaluation

    Around twelve months after treatment started, you will undergo a detailed assessment to determine if you have achieved a complete response without detectable disease (called MRD‑negative CR). this involves additional blood and bone‑marrow tests.

  7. Step 7

    Follow‑up for progression‑free survival

    After the treatment period ends, you will continue to be monitored for signs of disease progression or death. follow‑up visits may be less frequent but will include regular health checks and imaging as required by the study.

Who can join the trial?

13 criteria

  • Be at least 18 years old or the legal adult age in your country at the time you sign the consent form.
  • Have a confirmed diagnosis of newly diagnosed multiple myeloma that meets the standard guidelines used by doctors (called the IMWG criteria).
  • Show measurable disease in the lab, which means one of the following:
    • Blood test shows a protein called M‑protein at a level of 1.0 g/dL or higher, or
    • Blood test shows a level of free light chains (a type of antibody fragment) of 10 mg/dL or more **and** an abnormal ratio between the two types (kappa and lambda), or
    • Urine test shows M‑protein of 200 mg in a 24‑hour collection if the free light chain test is not available.
    • Not be a candidate for high‑dose chemotherapy with a stem‑cell transplant because of advanced age or other health problems that would make the treatment unsafe.
    • Have an ECOG performance status score of 0, 1, or 2, which means you are able to carry out daily activities with at most some limitation.
    • Have adequate kidney function, measured by an eGFR (estimated glomerular filtration rate) of at least 30 mL/min/1.73 m², a test that estimates how well your kidneys filter waste.
    • Have acceptable liver function, shown by:
      • Blood levels of AST and ALT (liver enzymes) less than 2.5 times the normal upper limit, and
      • Total bilirubin (a waste product processed by the liver) less than 1.5 times the normal upper limit, unless you have a harmless condition like Gilbert’s syndrome, in which case a different bilirubin limit applies.
      • Have adequate blood counts, including:
        • Hemoglobin (the protein that carries oxygen) of at least 7.5 g/dL, without a red‑blood‑cell transfusion in the past 7 days,
        • Platelet count of at least 75 × 10⁹/L (or at least 50 × 10⁹/L if a high percentage of your bone‑marrow cells are plasma cells), without a platelet transfusion or medication that raises platelets in the past 7 days,
        • Absolute neutrophil count (a type of white blood cell) of at least 1.0 × 10⁹/L.

Who cannot join the trial?

23 criteria

  • If your Myeloma Frailty Score is 2 or higher (except when the score is 2 only because of age), you cannot join the study.
  • If you have an active hepatitis infection (a liver disease caused by a virus), you are not eligible.
  • If you have already received any treatment for multiple myeloma or smoldering myeloma, except a short emergency course of steroids, you cannot participate. Steroid use must not exceed 160 mg of dexamethasone (or an equivalent dose).
  • If you have had radiation therapy to the bone lesions that can be measured, you are excluded, unless the radiation covered only a very small part (5% or less) of your bone marrow and was given for pain relief.
  • If you had a plasma‑exchange procedure (called plasmapheresis) within 28 days before randomization, you cannot join.
  • If you have any uncontrolled illness, such as:
  • Severe lung disease that spreads widely (acute diffuse infiltrative pulmonary disease),
  • Chronic obstructive pulmonary disease (COPD) with lung function less than 50% of normal (measured as FEV1),
  • Moderate or severe asthma that has not been controlled in the past two years,
  • Active infection that needs antiviral, antifungal, or antibacterial medicines,
  • Active autoimmune disease that needed strong immune‑suppressing drugs in the last six months,
  • Serious mental health problems (like alcohol or drug dependence, severe dementia, or confused mental state),
  • A stroke, mini‑stroke (transient ischemic attack), or seizure within the last six months.
  • If you are allergic or intolerant to any of the study drugs or their inactive ingredients, you cannot take part.
  • If you had major surgery (requiring general anesthesia) or a serious injury within two weeks before the first dose, or you have not fully recovered, or you plan to have surgery during the study period, you are excluded.
  • If you have had any of the following heart problems within six months before the first dose: severe or unstable chest pain (angina), heart attack (myocardial infarction), major blood clot events, dangerous heart rhythm problems (ventricular arrhythmias), or advanced heart failure (class III‑IV), you cannot join.
  • If you have another cancer condition, such as:
  • Ongoing myelodysplastic syndrome (a bone‑marrow disorder) or a B‑cell blood cancer other than multiple myeloma,
  • A past cancer that is considered high‑risk for coming back and would need systemic therapy,
  • An active cancer that is still progressing or needed a treatment change in the last 24 months, except for cancers that are considered cured with very low risk of returning.
  • If you have plasma cell leukemia, Waldenström’s macroglobulinemia, POEMS syndrome (a group of symptoms including nerve problems, organ enlargement, hormone issues, a specific protein, and skin changes), or systemic light‑chain amyloidosis, you are not eligible.
  • If you have current or past involvement of the central nervous system (brain or spinal fluid) with myeloma, or show signs that the disease may have spread to the brain membranes, you cannot participate. This would require a clear brain MRI and spinal fluid test.
  • If you have poorly controlled HIV infection, you are excluded.
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Investigated drugs

  • Ramantamig

    is an experimental medicine being tested in this study. It is given together with daratumumab to see if the combination can keep the disease from getting worse for a longer time and increase the chance of a deep response. Researchers want to know if adding ramantamig improves outcomes compared with the standard treatments.

  • Daratumumab

    is a targeted antibody that helps the immune system recognize and kill myeloma cells. In this trial it is used in two ways: together with ramantamig in the experimental group, and as part of the standard treatment options (either with bortezomib, lenalidomide, and dexamethasone, or with lenalidomide and dexamethasone) in the control groups. It is given by injection under the skin.

  • Bortezomib

    is a medicine that blocks a protein‑degrading system inside cancer cells, leading to their death. In the study it is one of the standard drugs that can be chosen by the investigator (the “DVRd” regimen) for patients who cannot receive a stem‑cell transplant. It is given by injection, either into a vein or under the skin.

  • Lenalidomide

    is an oral drug that modifies the immune system and directly attacks myeloma cells. It is part of the standard treatment options (both “DVRd” and “DRd” regimens) that doctors may select for patients in the control arm. Patients take it as a capsule taken by mouth.

  • Dexamethasone

    is a steroid that reduces inflammation and helps kill cancer cells. It is combined with other medicines in the standard regimens (either “DVRd” or “DRd”) that serve as the comparator treatments. It is taken as a tablet taken by mouth.

  • JNJ-79635322

    is a laboratory‑created antibody that can bind to three different targets on immune and myeloma cells at once. It is being tested as a new therapy in this trial and is given as a subcutaneous injection. The study will evaluate whether this novel antibody can improve disease control compared with the standard treatment choices.

What is already known about the treatment

  • Lenalidomide

    This medication is taken by mouth as hard capsules. It is an approved immunomodulatory drug used mainly for treating multiple myeloma and certain blood disorders. It works by changing the activity of immune cells, stopping the growth of cancer cells, and reducing new blood‑vessel formation that feeds tumors. Lenalidomide belongs to the class of immunomodulatory imide drugs (IMiDs).

  • Dexamethasone

    Dexamethasone is a tablet taken orally. It is a widely approved corticosteroid used to reduce inflammation and to help control cancer‑related symptoms in multiple myeloma. It acts by binding to glucocorticoid receptors, which lowers the activity of immune cells and decreases swelling. Its pharmacological class is glucocorticoid steroid.

  • Daratumumab

    Daratumumab is given as a subcutaneous injection in a solution for injection. It is an approved monoclonal antibody indicated for multiple myeloma, often used in combination with other drugs. The antibody attaches to the CD38 protein on myeloma cells, signaling the immune system to destroy those cells. It is classified as a CD38‑targeted monoclonal antibody.

  • Bortezomib

    Bortezomib is supplied as a powder that is reconstituted and given by intravenous or subcutaneous injection. It is an approved proteasome inhibitor used to treat multiple myeloma and mantle‑cell lymphoma. It blocks the proteasome, a cellular complex that breaks down proteins, causing a buildup of faulty proteins that leads to cancer‑cell death. Its class is proteasome inhibitor.

  • JNJ‑79635322

    JNJ‑79635322 is administered as a subcutaneous injection of a sterile solution. It is an investigational trispecific monoclonal antibody currently in clinical trials and has orphan‑drug designation for multiple myeloma. The antibody is designed to bind three targets: CD3 on T‑cells, BCMA on myeloma cells, and GPRC5D, directing T‑cells to attack the cancer cells. It belongs to the class of trispecific immune‑engaging antibodies.

Investigated diseases

Multiple Myeloma - Multiple myeloma is a cancer of plasma cells that live in the bone marrow. Abnormal plasma cells multiply and produce large amounts of a single type of antibody. The excess cells crowd out normal blood‑forming cells, leading to anemia, infections, and reduced platelets. They also cause bone damage, resulting in pain and fractures. Over time the disease can spread to other bones and organs, and the abnormal protein can affect kidney function. The condition is considered newly diagnosed when it is first recognized.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526654-14-01Protocol code79635322MMY3004Estimated enrolment1 000 patientsSponsorJanssen Cilag International

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