Not yet recruitingRare disease

Teclistamab drug combination versus daratumumab and lenalidomide in MRD‑positive multiple myeloma patients after stem cell transplant

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What is this trial about?

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

Multiple Myeloma is a cancer that starts in the cells that make antibodies and grows in the bone marrow. Even after a high‑dose treatment called autologous hematopoietic stem cell transplantation, some patients still have a very small amount of disease that can be found with special laboratory tests, known as minimal residual disease. The study looks at people whose disease is still detectable after this transplant.

One group of participants receives two new medicines, teclistamab and talquetamab, which are given as injections under the skin. The other group receives the already‑approved drug daratumumab, also given by injection, together with the oral pill lenalidomide. All participants continue the assigned therapy for about a year while being checked regularly.

The purpose of the study is to see which maintenance approach is better at achieving a state where no disease can be detected and the patient has a complete response after 12 months. Participants visit the clinic at scheduled intervals for injections, take oral medication as directed, and undergo blood tests and occasional bone‑marrow examinations to determine if the cancer has become undetectable and to monitor safety.

The research process

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

Step 1
Enrollment and randomization
After joining the study, you will be assigned by chance to one of two treatment groups. the assignment is made by the study team and you will not know which group you are in.
The two possible groups are: the test group that receives teclistamab and talquetamab, or the comparator group that receives daratumumab and lenalidomide.
Step 2
Start of maintenance therapy
Once randomization is complete, you will begin the maintenance phase of treatment. this phase begins after your autologous stem cell transplant and continues for the duration of the study.
The specific medicines you receive depend on the group to which you were assigned.
Step 3
Subcutaneous injections
If you are in the test group, you will receive two separate subcutaneous (under the skin) injections: teclistamab and talquetamab. each dose is calculated based on your body weight (milligrams per kilogram for teclistamab and micrograms per kilogram for talquetamab) as defined by the study protocol.
If you are in the comparator group, you will receive a subcutaneous injection of daratumumab at a fixed dose of 1800 mg each time it is scheduled.
Step 4
Oral medication (comparator only)
Participants assigned to the comparator group will also take an oral capsule of lenalidomide at a dose of 15 mg. the medication is taken as directed by the study protocol.
Step 5
Regular clinic visits and assessments
Throughout the maintenance period you will attend scheduled clinic visits. during each visit, healthcare staff will check for side effects, measure blood counts, and perform other safety tests.
The study also includes disease assessments to monitor the level of myeloma cells in your body.
Step 6
Month‑12 evaluation for mr d‑negative complete response
At month 12 of the maintenance phase, a special evaluation is performed to determine whether the disease is undetectable (mr d‑negative) and whether you have achieved a complete response. this measurement is the primary goal of the study.
Step 7
Ongoing follow‑up until study end
After the month‑12 evaluation, you will continue to be monitored for additional outcomes such as progression‑free survival, overall survival, and any serious adverse events.
The study is planned to continue until the estimated end date in 2033, and you will remain in follow‑up according to the schedule defined by the protocol.

Who can join the trial?

8 criteria

Be an adult (18 years or older) with a confirmed diagnosis of multiple myeloma, a type of blood cancer, based on the guidelines set by the International Myeloma Working Group (IMWG criteria).
Have recently been diagnosed and already completed a single or double autologous stem cell transplantation (ASCT), which is a procedure that uses your own stem cells after strong initial (induction) treatment that included an anti‑CD38 antibody (a medicine that targets a protein on cancer cells), an immunomodulatory drug (a drug that helps the immune system fight cancer), and a proteasome inhibitor (a drug that blocks a process cancer cells need to grow).
Show a positive result for measurable residual disease (MRD) in the bone marrow at a very sensitive level of 10⁻⁵, meaning a very small number of cancer cells are still detectable after the transplant and before being randomly assigned to a treatment group.
Be within the study’s specific time period after the transplant, whether or not you received additional “consolidation” therapy (extra treatment given to strengthen the response).
Have an adequate performance status, meaning you are able to carry out daily activities: a Karnofsky score of 50% or higher (a scale that rates your ability to function) or an ECOG score of 2 or lower (another scale that measures how disease affects your daily life).
Have sufficient organ health, including blood (hematologic), kidney (renal), liver (hepatic), and calcium levels, as defined by the study’s safety rules.
Agree to follow any required birth‑control measures during the trial, if applicable, to prevent pregnancy.
Provide written, informed consent, meaning you understand the study and agree to take part before any study procedures begin.

Who cannot join the trial?

9 criteria

Having serious nerve problems, such as painful tingling or numbness that is moderate to severe (Grade 2 or higher) or having multiple myeloma spread to the brain or spinal cord.
Having serious lung disease, such as severe asthma that is not well‑controlled or chronic obstructive pulmonary disease (COPD) that makes breathing difficult.
Having another cancer that is currently active or likely to return, unless that cancer is considered completely cured according to the study rules.
Having blood‑related disorders other than multiple myeloma, such as plasma cell leukemia, Waldenström’s macroglobulinemia, POEMS syndrome, or AL amyloidosis.
Having serious heart problems, such as uncontrolled heart failure, a recent heart attack, dangerous heart rhythm problems (arrhythmias), or abnormal results on an electrocardiogram (ECG).
Having other medical or mental health conditions that could increase risk, make it hard to follow the study, or affect the results, such as ongoing serious infections or autoimmune diseases (unless the study specifically allows them).
Being allergic, overly sensitive, or unable to tolerate any of the study medicines or other required drugs.
Having received certain treatments or procedures that are not allowed, such as recent prohibited therapies, plasmapheresis (plasma exchange), major surgery, or live vaccines within the time limits set by the study.
Having an active viral infection, such as HIV, hepatitis B, or hepatitis C.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie
Verified
Lublin, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

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Investigated drugs

Talquetamab
is an experimental medicine given as a liquid that is injected under the skin. In this study it is used as part of the new “Tec‑Tal” maintenance treatment. The drug is designed to help the immune system recognize and attack myeloma cancer cells after a stem cell transplant.
Teclistamab
is another experimental medicine that comes as a liquid for subcutaneous injection. It is also part of the “Tec‑Tal” maintenance regimen. Like talquetamab, it works by directing the body’s immune cells to find and kill multiple myeloma cells.
Daratumumab (Darzalex)
is an approved antibody therapy that is injected under the skin. In this trial it serves as the comparator drug in the standard “DR” maintenance approach. Daratumumab helps the immune system target myeloma cells and is given together with lenalidomide.
Lenalidomide (Revlimid)
is a pill taken by mouth. It is used in the standard “DR” maintenance arm alongside daratumumab. Lenalidomide works by modifying the immune environment and slowing the growth of myeloma cells.

What is already known about the treatment

Talquetamab
This medication is given as a subcutaneous injection in a liquid solution. It is still being studied in clinical trials and has orphan‑drug status for multiple myeloma. Talquetamab works by attaching to a protein called GPRC5D on myeloma cells and to CD3 on T‑cells, bringing the immune cells close enough to destroy the cancer cells. It belongs to the class of bispecific T‑cell‑engaging antibodies.
Daratumumab
Daratumumab is administered as a subcutaneous injection of a ready‑to‑use solution. It is an approved, marketed drug and also carries orphan‑drug designation for multiple myeloma. The drug binds to the CD38 protein on myeloma cells, marking them for attack by the immune system. It is classified as an anti‑CD38 monoclonal antibody.
Lenalidomide
Lenalidomide comes in hard oral capsules that are swallowed. It is an approved therapy for multiple myeloma and is widely used in everyday practice. The medicine changes the activity of immune cells and blocks the growth of new blood vessels that feed the tumor, leading to cancer cell death. It is part of the immunomodulatory imide drug (IMiD) class.
Teclistamab
Teclistamab is delivered as a subcutaneous injection in a liquid solution. It is an investigational drug currently being tested in trials for multiple myeloma. The drug links T‑cells to myeloma cells by binding BCMA on the cancer cells and CD3 on T‑cells, prompting the immune system to kill the tumor. It is another bispecific T‑cell‑engaging antibody.

Investigated diseases

Multiple myeloma - Multiple myeloma is a cancer that starts in the plasma cells, a type of white blood cell that makes antibodies. Over time, the abnormal cells build up in the bone marrow, crowding out normal blood‑forming cells and causing bone damage. As the disease progresses, the number of cancerous plasma cells increases, leading to higher levels of abnormal proteins in the blood and worsening of symptoms.