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Accelerating improvement with teclistamab plus standard drug combination in newly diagnosed transplant‑eligible multiple myeloma patients

Fast replyRegistered drugNo placebo
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What is this trial about?

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

The trial focuses on patients who have been newly diagnosed with Multiple Myeloma, a cancer that starts in the cells that make blood in the bone marrow. Participants will receive either a new combination that includes teclistamab together with the standard drugs lenalidomide, bortezomib, daratumumab and dexamethasone (called Tec‑DRd), or the usual regimen of lenalidomide, bortezomib, dexamethasone and melphalan (DVRd) followed by a high‑dose chemotherapy and autologous stem cell transplantation, where a patient’s own blood‑forming cells are collected, stored, and later returned after intensive treatment.

The purpose of the study is to compare how well the two treatment plans clear the disease before patients start long‑term maintenance therapy. After an initial series of treatment cycles, patients undergo the transplant procedure, then receive a maintenance phase that can last up to two years, with regular check‑ups along the way.

Researchers will look for MRD negativity, which means no cancer cells can be found using a very sensitive test, indicating a deep response to treatment. The study will track how many participants achieve this level of response and whether it stays low for at least a year during the maintenance period.

The research process

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

  1. Step 1

    Start of treatment

    On the first day after joining the study, baseline assessments are performed and the medication schedule begins.

    The oral medication lenalidomide is taken at a dose of 25 mg each day.

    The oral medication dexamethasone is taken at a dose of 40 mg according to the study schedule.

    Subcutaneous injections are given as follows:

    teclistamab at 3 mg per kilogram of body weight, or bortezomib at 1.3 mg per square meter, depending on the assigned treatment arm.

    daratumumab is administered as a single subcutaneous injection of 1800 mg.

  2. Step 2

    Induction therapy (six cycles)

    The patient receives six consecutive cycles of treatment, each cycle lasting approximately four weeks.

    During each cycle the oral doses of lenalidomide (25 mg) and dexamethasone (40 mg) are continued as instructed.

    Subcutaneous injections of teclistamab (3 mg/kg) or bortezomib (1.3 mg/m²) and daratumumab (1800 mg) are given on the days specified by the protocol.

    The purpose of these six cycles is to reduce disease activity before further therapy.

  3. Step 3

    High‑dose melphalan and autologous stem cell transplantation

    After completing induction, the patient undergoes collection of his or her own stem cells.

    A high dose of the chemotherapy drug melphalan is administered to eliminate remaining cancer cells.

    The previously collected stem cells are then infused back into the patient (autologous stem cell transplantation) to restore normal blood cell production.

  4. Step 4

    Assessment before maintenance

    Once recovery from transplantation is sufficient, tests are performed to determine mrd negativity (minimal residual disease at a sensitivity of 10⁻⁶).

    The results guide whether the patient proceeds to the next phase of the study.

  5. Step 5

    Maintenance therapy

    If the assessment is completed, the patient begins a maintenance phase that can continue for up to 24 months.

    The same oral medications (lenalidomide 25 mg and dexamethasone 40 mg) are taken as prescribed, and any additional study drugs are given according to the maintenance schedule.

    Regular follow‑up visits are scheduled to monitor disease status and safety.

Who can join the trial?

13 criteria

  • Be between 18 and 70 years old (inclusive).
  • If you are male, you must agree not to donate sperm for making a baby during the study and for three months after your last dose; you may want to save sperm before treatment because the cancer drugs can affect fertility.
  • You must agree not to donate blood while you are taking the drug lenalidomide and for 28 days after you stop taking it.
  • You must sign an informed consent form showing that you understand the study and agree to take part.
  • You must be willing and able to follow the lifestyle rules listed in the study protocol.
  • You must have a confirmed diagnosis of multiple myeloma that meets international (IMWG) criteria, has not been treated before, and shows measurable disease, which means at least one of the following: a blood test showing an M‑protein level of ≥ 1.0 g/dL, a urine test showing an M‑protein level of ≥ 200 mg in 24 hours, or a blood test showing a free light‑chain level of ≥ 10 mg/dL together with an abnormal kappa/lambda ratio.
  • Your overall health must allow you to perform daily activities, measured by an ECOG performance status of 0, 1, or 2 (0 = fully active, 2 = up and about more than half the day).
  • Your recent lab tests must meet these minimum values: hemoglobin ≥ 8 g/dL (measure of red blood cells), platelet count ≥ 75 × 10⁹/L if less than half of bone‑marrow cells are cancer cells or ≥ 50 × 10⁹/L if half or more are cancer cells (helps blood clot), absolute neutrophil count ≥ 1.0 × 10⁹/L (type of white blood cell), liver enzymes AST and ALT ≤ 3 times the normal upper limit, total bilirubin ≤ 2.0 times the normal upper limit (or special rule for certain conditions), kidney function eGFR ≥ 30 mL/min, and calcium level in blood ≤ 14 mg/dL (or ionized calcium ≤ 6.5 mg/dL).
  • You must be considered suitable for high‑dose melphalan chemotherapy and autologous stem cell transplantation (using your own stem cells), as judged by the investigator.
  • If you are a female who could become pregnant, you must have a negative pregnancy test at screening and again within 24 hours before starting treatment, and you must agree to continue pregnancy testing during the study.
  • If you are a female of child‑bearing potential, you must either be not able to become pregnant, or you must use at least one highly effective method of contraception (such as birth control pills, IUD, etc.) throughout the study.
  • If you are a female, you must agree not to donate or freeze eggs for assisted reproduction during the study and for six months after your last dose; you may want to preserve eggs before treatment because the cancer drugs can affect fertility.
  • If you are a male, you must use a condom (with or without spermicidal product) during any sexual activity that could lead to ejaculation reaching another person during the study and for three months after your last dose.

Who cannot join the trial?

22 criteria

  • Having an ongoing myelodysplastic syndrome or another B‑cell malignancy (cancer of certain white blood cells) besides multiple myeloma.
  • Receiving a high dose of corticosteroids (equivalent to dexamethasone ≥ 160 mg) within 14 days before the study starts.
  • Getting a live, weakened‑virus vaccine (a live attenuated vaccine) within 4 weeks before the first dose of the study drug.
  • Having major surgery or a serious injury within 2 weeks before treatment, not being fully recovered from it, planning major surgery during the study, or having surgery within 2 weeks after the last dose.
  • Having a medical or psychiatric condition that could interfere with the study, such as acute lung disease, an active infection that needs medication, an autoimmune disease needing strong immune‑suppressing drugs in the past 6 months (except stable vitiligo, controlled type I diabetes, or treated thyroid disease), severe mental health problems, alcohol or drug abuse, severe dementia, or any issue that makes the treatment unsafe or hard to follow.
  • Experiencing a stroke, mini‑stroke (transient ischemic attack), or seizure within the last 6 months.
  • Testing positive for HIV, hepatitis B, or having an active hepatitis C infection (unless hepatitis C has been cured and is undetectable).
  • Having chronic obstructive pulmonary disease (COPD) with lung function (FEV1) less than 50 % of normal, or having moderate to severe asthma in the past 2 years or uncontrolled asthma.
  • Having certain heart problems, including advanced heart failure (NYHA class III or IV), a heart attack, unstable chest pain, or heart bypass surgery within the past 6 months, serious irregular heart rhythms or unexplained fainting, or uncontrolled heart rhythm issues or important ECG (heart‑test) abnormalities.
  • Being pregnant, breastfeeding, or planning to become pregnant during the study or for 6 months after the last dose.
  • Planning to father a child during the study or for 3 months after the last dose.
  • Having a known allergy (hypersensitivity) to the study drug, any similar medication, or any ingredient in the drug formulation.
  • Having a history of another cancer that is likely to return and needs systemic (body‑wide) therapy.
  • Currently participating in another clinical trial or having a competing study observation period.
  • Being held in a facility by legal or official order.
  • Being legally unable to give informed consent.
  • Having any active cancer (other than multiple myeloma) that has progressed or required a treatment change in the last 24 months, except for specific cancers considered cured (such as certain non‑muscle‑invasive bladder cancers, non‑melanoma skin cancers, localized cervical cancer, certain breast or prostate cancers, or other cancers judged to have minimal risk of coming back).
  • Having certain plasma‑cell disorders such as plasma cell leukemia, smoldering multiple myeloma, Waldenström’s macroglobulinemia, POEMS syndrome, or primary light‑chain amyloidosis.
  • Showing signs that the disease has spread to the brain or spinal fluid (meningeal involvement) without a negative whole‑brain MRI and spinal fluid test.
  • Having previously received therapy that targets BCMA (a protein on myeloma cells) or any T‑cell redirection therapy.
  • Having had a previous stem cell transplant (allogeneic or autologous) or any organ transplant.
  • Having recent exposure (within the specified time frames) to certain investigational treatments or radiation, including targeted or epigenetic therapy or any investigational drug/device within 21 days or five half‑lives, an investigational vaccine within 4 weeks, a monoclonal antibody therapy within 21 days, or radiation therapy within 14 days (or focal radiation within 7 days).
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Investigated drugs

  • Lenalidomide

    is an oral medicine that helps slow the growth of myeloma cells. In this study it is used as part of the standard treatment backbone for patients with newly diagnosed multiple myeloma. It works together with other drugs to keep the disease under control before patients receive a stem‑cell transplant.

  • Bortezomib

    is a medication given by injection under the skin. It belongs to a class of drugs that block a process cancer cells need to survive, helping to kill myeloma cells. In the trial it is included in the standard regimen that serves as a comparison for the new therapy.

  • Daratumumab

    is a drug that is injected under the skin and targets a protein found on myeloma cells. By binding to this protein, it helps the immune system recognize and destroy the cancer cells. It is part of both the standard treatment and the experimental treatment being tested.

  • Dexamethasone

    is a steroid taken by mouth that reduces inflammation and can help cancer cells die. It is used together with the other medicines to improve their effectiveness and to manage side effects during treatment.

  • Teclistamab

    is a newly developed injectable medicine that directs the immune system to attack myeloma cells. In the trial it is the experimental component added to the standard regimen to see if it can improve the depth of response compared with the existing standard treatment.

What is already known about the treatment

  • Lenalidomide

    This medication is taken as a hard capsule by mouth. It is an approved drug that is widely used and studied for treating multiple myeloma. Lenalidomide works by changing the activity of immune cells and the environment around cancer cells, helping the body fight the disease. It belongs to the class of immunomodulatory imide drugs (IMiDs).

  • Teclistamab

    Teclistamab is given as a subcutaneous injection in a liquid solution. It is currently under investigation in clinical trials for multiple myeloma and is not yet fully approved. The drug is a bispecific antibody that connects T‑cells to cancer cells, prompting the immune system to kill the myeloma cells. It is classified as a bispecific T‑cell engager.

  • Bortezomib

    Bortezomib is administered by subcutaneous injection as a powder that is mixed into a solution. It is an approved proteasome inhibitor used for multiple myeloma treatment. The medication blocks the cell’s protein‑degrading system, causing cancer cells to accumulate damaged proteins and die. It belongs to the proteasome inhibitor class.

  • Daratumumab

    Daratumumab is given as a subcutaneous injection in a ready‑to‑use solution. It is an approved monoclonal antibody for multiple myeloma therapy. The drug binds to the CD38 protein on myeloma cells, marking them for destruction by the immune system. It is classified as a monoclonal antibody.

  • Dexamethasone

    Dexamethasone is taken orally as a tablet. It is a well‑known and approved corticosteroid used in many diseases, including multiple myeloma. The medication reduces inflammation and can directly trigger death of myeloma cells by suppressing certain immune pathways. It belongs to the glucocorticoid class.

Investigated diseases

Multiple Myeloma - Multiple Myeloma is a cancer that starts in the plasma cells of the bone marrow. Abnormal plasma cells multiply and crowd out normal blood‑forming cells, leading to reduced red blood cells and weakened immunity. The disease often produces excess abnormal antibodies that can damage the kidneys. As the cancer grows, it can cause bone pain, weaken bones, and create areas of bone loss that may result in fractures. Over time, the accumulation of malignant cells can affect the function of several organ systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523990-40-00Protocol codeGMMG-HD11/DSMM XXIEstimated enrolment399 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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