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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Lausitz Carl Thiem	Cottbus	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Diakonie-Klinikum Schwaebisch Hall gGmbH	Schwäbisch Hall	Germany
Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität	Nürnberg	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH	Essen	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Westpfalz-Klinikum GmbH	Kaiserslautern	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Rotkreuzklinikum Muenchen gGmbH	Munich	Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
HELIOS Klinikum Bad Saarow GmbH	Bad Saarow	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Staedtisches Klinikum Dessau	Dessau-Roßlau	Germany
Diakonie in Suedwestfalen gGmbH	Siegen	Germany
Rems-Murr-Kliniken gGmbH	Winnenden	Germany
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
Friedrich-Schiller-Universität Jena	Jena	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Gkovhycmgkbtnnqejkguv Mdkirlwtuss gtglt	Koblenz	Germany
Uluunwxwcsgackabkyems Kownarknhznvytrcttmiren Bhjpif Gopn	Bochum	Germany
Kauuljyilvmo Kgrriowwtyx Hnisf Sr Jvepax Hufiiogv	Hagen	Germany
Cyiaxdb fsm Hrsveabtssa uxo Omxcnaqjs ay Bxkotlborzfaxlujdtoig	Frankfurt	Germany
Ujtqmbngqyuobzstyyqym Dokbxplnksj Apa	Duesseldorf	Germany
Unigvcqizhidwpvxeokcr Mlhniqqs Adj	Munster	Germany
Utvmuovfdnltjhwqlqvvn Wjabmkkja Atv	Wuerzburg	Germany
Usslxwnmtheumfoeyykfx Asvsmtxv	Augsburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.06.2026

Trial locations

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.

Investigated diseases:

Plasma cell myeloma

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 ID:

2025-523990-40-00

Protocol code:

GMMG-HD11/DSMM XXI

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?