Study of teclistamab plus drug combination in newly diagnosed multiple myeloma patients eligible for stem cell transplant

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What is this study about?

The study involves patients who have been newly diagnosed with Multiple Myeloma and are considered suitable for stem cell transplantation. The treatment plan includes a combination of medicines that are already used for this disease: oral capsules of lenalidomide, subcutaneous injections of bortezomib and daratumumab, and a pill of dexamethasone. In addition, participants will receive the investigational drug teclistamab, which is given as a subcutaneous injection and is being tested to see if it improves outcomes when added to the standard regimen.

The purpose of the trial is to find out whether the new combination can achieve a higher rate of MRD negativity—meaning that a very sensitive laboratory test cannot detect any remaining cancer cells—compared with the standard therapy. This deep‑response test is performed using NGS, a method that examines tiny pieces of DNA to look for cancer cells. Participants will go through several treatment cycles, followed by a high dose of chemotherapy called high dose melphalan and an autologous stem cell transplant, after which they will begin maintenance therapy to keep the disease under control. The study monitors patients for up to two years to see how well the cancer stays absent and how safe the treatment is.

1 enrollment and baseline assessments

after you consent to join the study, you will undergo initial medical examinations, laboratory tests, and imaging studies to document the status of your multiple myeloma before any treatment is given.

2 start of induction therapy

you will begin the first phase of treatment, called induction therapy. the regimen includes several medicines:

lenalidomide 25 mg taken by mouth each day,

dexamethasone 40 mg taken by mouth on the days specified by the study protocol,

bortezomib (Velcade) 1.3 mg/m² given as a subcutaneous injection on the scheduled days of each cycle,

daratumumab 1800 mg given as a subcutaneous injection according to the study schedule,

and, depending on the randomised group, either:

• teclistamab 3 mg per kilogram of body weight given as a subcutaneous injection on the prescribed days, or

• the standard background drugs without teclistamab.

all injections are performed by trained staff in the clinic.

3 completion of induction cycles

the induction phase consists of six treatment cycles. each cycle lasts about four weeks, so the whole induction period lasts roughly six months.

you will continue to take the oral medicines each day and receive the injections on the days defined by the protocol throughout all six cycles.

regular check‑ups and laboratory tests will be performed to monitor response and safety.

4 high‑dose melphalan conditioning

after the six induction cycles, you will receive a high dose of the chemotherapy drug melphalan to prepare your body for stem cell transplantation.

the melphalan is given intravenously on a single day according to the study schedule.

5 autologous stem cell transplantation

following the high‑dose melphalan, you will undergo autologous stem cell transplantation.

your own previously collected stem cells are infused back into your bloodstream to help restore blood‑forming cells that were damaged by the chemotherapy.

you will stay in the hospital for several days for monitoring and supportive care.

6 start of maintenance therapy

once you have recovered from the transplantation, you will begin the maintenance therapy phase.

maintenance typically includes continued oral lenalidomide at the same dose (25 mg daily) and may include other low‑dose medications as defined by the protocol.

this phase continues until the end of the study or until your physician decides to stop treatment.

Who Can Join the Study?

Be between 18 and 70 years old, inclusive.
If you are male, you must agree not to donate sperm during the study and for three months after your last dose; you may want to store sperm beforehand because the treatment can affect fertility.
You must agree not to donate blood while taking the medicine lenalidomide and for 28 days after you stop taking it.
You must sign an informed consent form (ICF), showing that you understand the study’s purpose and procedures and agree to take part.
You must be willing and able to follow the lifestyle rules described in the study protocol.
You must have a documented diagnosis of Multiple Myeloma (MM) that meets the official International Myeloma Working Group (IMWG) criteria, is untreated, requires systemic therapy, and shows measurable disease. Measurable disease means at least one of the following lab results: a blood (serum) M‑protein level of 1.0 g/dL or higher, a urine M‑protein level of 200 mg per 24 hours or higher, or a blood free light chain level of 10 mg/dL or higher together with an abnormal ratio of kappa to lambda light chains.
Your overall health must be good enough to perform daily activities, measured by an ECOG performance status score of 0, 1, or 2 at screening and right before starting treatment. (ECOG scores range from 0 = fully active to 5 = dead; 0‑2 means you are able to care for yourself.)
Your lab test results must meet the following minimum values:
- Hemoglobin (the part of blood that carries oxygen) ≥ 8 g/dL.
- Platelets (cells that help clot blood) ≥ 75 × 10⁹/L if less than half of your bone‑marrow cells are plasma cells, or ≥ 50 × 10⁹/L if half or more are plasma cells.
- Absolute neutrophil count (a type of white blood cell) ≥ 1.0 × 10⁹/L.
- AST and ALT (liver enzymes) each ≤ 3 times the upper normal limit.
- Total bilirubin (a liver waste product) ≤ 2.0 times the upper normal limit (or, if you have a condition like Gilbert syndrome, direct bilirubin ≤ 1.5 times the limit).
- eGFR (estimated kidney function) ≥ 30 mL/min, calculated with the Cockcroft‑Gault formula or measured by a 24‑hour urine test.
- Corrected calcium (blood calcium adjusted for albumin) ≤ 14 mg/dL, or ionized calcium ≤ 6.5 mg/dL.
You must be considered eligible for high‑dose melphalan chemotherapy and autologous stem cell transplantation (ASCT) by your doctor.
If you are a female who could become pregnant, you must have a negative, highly sensitive pregnancy test at screening and another test within 24 hours before starting treatment, and you must agree to continue pregnancy testing during the study.
Female participants must either be unable to become pregnant or, if they can become pregnant, must use at least one highly effective method of contraception (such as hormonal birth control, intrauterine device, or sterilization) throughout the study.
If you are a female participant, you must agree not to donate or freeze eggs (ova) for assisted reproduction during the study and for six months after your last dose; you may want to preserve eggs before treatment because the therapy can affect fertility.
If you are a male participant, you must use a condom (with or without spermicide) for any sexual activity that could lead to ejaculation to another person during the study and for three months after your last dose.

Who Cannot Join the Study?

Having an ongoing myelodysplastic syndrome (a bone‑marrow disorder) or another B‑cell cancer that is not multiple myeloma.
Having taken a large amount of steroids (equivalent to 160 mg or more of dexamethasone) within the 14 days before the study starts.
Receiving a live, weakened‑virus vaccine (such as measles‑mumps‑rubella) within 4 weeks before the first study dose.
Having major surgery or a serious injury within 2 weeks before treatment, not fully recovered from it, or planning such surgery during the study period.
Having a medical or psychiatric condition that could interfere with the study, including: acute diffuse infiltrative lung disease (a severe lung problem), an active infection that needs antibiotics, antifungal, or antiviral medicines, an autoimmune disease that required strong immune‑suppressing drugs in the past 6 months (except well‑controlled vitiligo, type I diabetes, or thyroid disease), severe mental‑health issues, alcohol or drug abuse, severe dementia, or confusion, any other problem that would make it hard to follow the study procedures or give informed consent, or a history of not following medical advice.
Having a stroke, a mini‑stroke (transient ischemic attack) or a seizure within the past 6 months.
Testing positive for HIV, having active hepatitis B infection, or having active hepatitis C infection (unless hepatitis C was cured and no virus is detectable).
Having moderate to severe chronic lung disease (COPD) or asthma with lung function (FEV1 – the amount of air exhaled in one second) less than 50 % of the predicted normal value.
Having certain heart problems, such as: severe heart failure (New York Heart Association class III or IV), a heart attack, unstable chest pain, or heart bypass surgery within the last 6 months, a significant irregular heartbeat or unexplained fainting not caused by dehydration, uncontrolled heart rhythm problems or major abnormalities on an electrocardiogram (ECG).
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 considered high‑risk for returning and would need systemic therapy.
Currently taking part in another clinical trial or observation study.
Being held in a facility by legal or official order.
Being legally unable to give informed consent.
Having another active cancer that is progressing or needed treatment in the last 24 months (certain cured cancers such as early bladder cancer, non‑melanoma skin cancer, localized cervical cancer, certain breast or prostate cancers, or other cancers considered cured may be exceptions).
Having 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), unless brain imaging and spinal fluid tests are completely normal.
Having previously received BCMA‑directed therapy (a type of targeted treatment).
Having previously received T‑cell redirection therapy (another type of immune‑based treatment).
Having had a prior stem cell transplant (either allogeneic or autologous) or any organ transplant.
Having taken any of the following within the specified time before randomization: a targeted or epigenetic therapy, an investigational drug, or an invasive investigational device within 21 days (or five drug half‑lives); an investigational vaccine within 4 weeks; a monoclonal antibody therapy within 21 days; 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
Gwgtmdmummygxhtuysyou Mzusyegjpyo gequc	Koblenz	Germany
Uwbgwstzuhsbcclsqgxhd Kyjefugtskaepmuehppeuhf Bgkkwi Gduv	Bochum	Germany
Karphuwqbtfe Krlkheokjcq Hkdno Sr Jyzpdo Hfrkmzmw	Hagen	Germany
Cyyjpzz fes Hwczwlqomge uea Ouforespx aw Bwmzomolhrvlzihnkyonh	Frankfurt	Germany
Uucopgtuuzczgpyyfvnpc Dqtzzyayjow Afa	Duesseldorf	Germany
Ubpjxrkibncqylydbbars Mspuazdh Ags	Munster	Germany
Uryiuogfcrdphwrworvwi Welcjyixj Amu	Wuerzburg	Germany
Uramsmkhkzaqmbzrskozw Adgkrkti	Augsburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Lenalidomide is an oral medicine taken in capsule form. In this trial it is part of the standard (background) treatment that all patients receive. It helps to slow the growth of myeloma cells and works together with other drugs to improve the response to therapy.

Teclistamab is given as a subcutaneous injection (under the skin). It is the experimental (test) drug being studied to see if it can increase the number of patients whose disease becomes undetectable. It works by directing the immune system to attack myeloma cells.

Bortezomib is a medication injected under the skin. It is included in the standard treatment regimen. It blocks a process that myeloma cells need to survive, helping to kill the cancer cells.

Daratumumab is also given as an injection under the skin. It is part of the background therapy. This drug is a type of antibody that binds to a protein on myeloma cells, marking them for destruction by the immune system.

Dexamethasone is an oral steroid taken as a pill. It is used in the standard treatment to reduce inflammation and help other anti‑myeloma drugs work better. It also helps control symptoms related to the disease.

Multiple Myeloma – Multiple Myeloma is a cancer of plasma cells that live in the bone marrow. It begins when abnormal plasma cells start to multiply and produce faulty proteins. These cells can push out normal blood‑forming cells, causing reduced blood counts. As the disease advances, the growing tumor cells can damage bone, making it weak or painful. The condition usually progresses slowly, with more abnormal cells and protein appearing in the blood over time. People may notice fatigue, bone pain, or frequent infections as the disease moves forward.

Trial ID:

2025-523990-40-00

Protocol code:

GMMG-HD11/DSMM XXI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of teclistamab plus drug combination in newly diagnosed multiple myeloma patients eligible for stem cell transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?