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Cevostamab plus pomalidomide and dexamethasone in patients with multiple myeloma previously treated with BCMA‑targeted CAR T‑cell therapy

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What is this trial about?

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

The study involves patients with Multiple Myeloma, a cancer of the bone‑marrow cells that produce blood cells. Some of these patients have already received a type of advanced treatment called CAR T-cell therapy, which uses the patient’s own immune cells that have been altered to attack the cancer. The new treatment being tested combines three medicines: cevostamab, which is given by a drip into a vein (intravenous infusion); pomalidomide, which is taken as a pill by mouth (oral); and dexamethasone, which is also given through a vein.

The purpose of the study is to see how well this combination works and how safe it is for people whose disease has come back after previous therapy. Participants will receive the medicines on a regular schedule, attend clinic visits for check‑ups, have blood drawn, and may have other simple tests to monitor how the disease is responding and to watch for any side effects.

The study continues for several months, during which doctors will look for any improvement in the cancer, record any problems that arise, and follow participants after treatment ends to see how long any benefit lasts.

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 baseline assessments
After joining the study you will have a series of baseline examinations. these include physical measurements, blood laboratory tests, imaging studies, and a bone marrow sample to confirm the status of multiple myeloma.
The results of these assessments will be used to determine eligibility for the treatment phase.
Step 2
First treatment day
On day 1 you will receive an intravenous infusion of cevostamab. the infusion is given through a vein over a period of time as specified in the study protocol.
On the same day you will also receive an intravenous dose of dexamethasone to help manage potential infusion‑related reactions.
You will begin taking pomalidomide capsules by mouth. the capsule strength (1 mg or 2 mg) and the exact daily dose are defined by the study protocol and will be taken each day as instructed.
Step 3
Subsequent treatment cycles
After the first day, cevostamab will be administered by intravenous infusion according to the schedule defined in the protocol (for example, weekly or monthly).
Each time cevostamab is given, a dose of dexamethasone may be administered intravenously shortly before the infusion to reduce side effects.
You will continue to take pomalidomide capsules orally each day throughout the treatment period, unless a dose adjustment is required.
Step 4
Regular monitoring visits
Throughout the study you will attend scheduled clinic visits. at each visit blood samples will be taken, vital signs will be measured, and questionnaires about symptoms and quality of life will be completed.
The study team will evaluate your response to treatment using standard criteria for multiple myeloma. imaging or bone‑marrow assessments may be performed at specified time points.
Step 5
Management of side effects
If any adverse events occur, the study protocol allows for temporary interruption, dose reduction, or discontinuation of any medication, including cevostamab, pomalidomide, or dexamethasone.
You will be instructed on how to report symptoms and may receive supportive medications as needed.
Step 6
Continuation of therapy
Treatment will continue until one of the following occurs: disease progression as determined by the study assessments, unacceptable toxicity, or the end of the planned study period.
The decision to stop therapy will be made based on the criteria outlined in the protocol.
Step 7
Final study assessment
At the end of the study you will undergo a final evaluation that includes blood tests, imaging, and possibly a bone‑marrow sample to document the overall response and any lasting effects of the therapy.
The results will be used to determine the overall efficacy and safety of the combination of cevostamab, pomalidomide, and dexamethasone in patients who have previously received bcma‑targeting car t‑cell therapy.

Who can join the trial?

7 criteria

You must have an ECOG Performance Status of 0 or 1 (fully active or able to do light work) at the start of the study, or a score of 2 only if the limitation is caused by myeloma‑related pain.
You need to be expected to live at least 12 weeks from the time you start the study.
You must have already received one line of BCMA‑targeting CAR T‑cell therapy (a type of personalized cell treatment that attacks myeloma cells).
Any side effects from previous cancer treatments, including peripheral neuropathy (numbness or tingling in the hands or feet), must have improved to mild severity (called Grade ≤ 1), except for hair loss, which can be any level.
You must have a confirmed diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
You need to have previously been treated with all three major classes of myeloma medicines: an anti‑CD38 therapy (a drug that targets a specific protein on myeloma cells), a proteasome inhibitor (a drug that blocks a cell process that myeloma cells need), and lenalidomide (an immunomodulatory drug).
You can be either male or female and must be an adult able to give informed consent.

Who cannot join the trial?

6 criteria

You have a known history of amyloidosis, a condition where abnormal protein builds up in tissues, confirmed by special lab tests such as a Congo Red stain or a serum amyloid P scan.
You have lesions (abnormal tissue growths) located very close to vital organs (essential organs like the heart, lungs, or brain) that could suddenly get worse if a temporary tumor growth called a tumor flare occurs.
You have plasma cell leukemia (a rare blood cancer) or a high number of plasma cells in your blood—more than 500 cells per microliter or more than 5% of your white blood cells.
You have had severe allergic reactions, including anaphylactic (life‑threatening) responses, to similar medicines called monoclonal antibodies (mAb therapy) or to any inactive ingredients (excipients) in cevostamab.
You have another medical or mental health condition that could make it difficult to follow the study procedures, could affect the study results, or could be unsafe for you to participate, as judged by the doctor.
You have a gastrointestinal (GI) disease (stomach or intestinal problem) that might significantly change how well you absorb medicines taken by mouth.

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
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Ulm, Germany
Klinikum Nuernberg
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Nürnberg, Germany

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Investigated drugs

Cevostamab
is an investigational drug given by IV infusion. It is a type of antibody that is designed to recognize and bind to a protein on myeloma cells, helping the immune system to find and destroy those cancer cells. In this study, it is being tested as the main treatment to see how well it works when used together with other medicines.
Pomalidomide
is an oral medication taken in capsule form. It belongs to a class of drugs that modify the immune system and can directly affect myeloma cells, slowing their growth. In the trial, it is combined with Cevostamab and dexamethasone to see if the three‑drug mix improves patients’ response to treatment.
Dexamethasone
is a steroid that is given by IV infusion. It helps reduce inflammation and can make cancer cells more vulnerable to other treatments. In this study, it is used alongside Cevostamab and pomalidomide to support the overall anti‑myeloma effect.

What is already known about the treatment

Cevostamab
This drug is given as an intravenous infusion using a concentrate that is mixed into a solution. It is still being studied in clinical trials and is recognized as an orphan drug for multiple myeloma. Cevostamab works by attaching to a protein called BCMA on cancer cells and to CD3 on T‑cells, bringing the immune cells close to the cancer to kill it. It belongs to the class of bispecific antibodies that engage T‑cells for cancer immunotherapy.
Pomalidomide
Pomalidomide is taken as a hard oral capsule. It is an approved medication for multiple myeloma and is listed in medical literature as an immunomodulatory drug. The medicine changes the activity of immune cells and blocks blood vessel growth that tumors need, mainly by binding to a protein called cereblon. It is classified as an immunomodulatory imide drug (IMiD).
Dexamethasone
Dexamethasone is administered by intravenous injection in this trial. It is a widely used, approved corticosteroid that has many uses, including as part of therapy for multiple myeloma. The drug works by attaching to glucocorticoid receptors inside cells, which then changes gene activity to lower inflammation and suppress the immune response. It belongs to the glucocorticoid class of anti‑inflammatory agents.

Investigated diseases

Multiple Myeloma - Multiple Myeloma is a cancer of plasma cells in the bone marrow. It develops when these cells grow uncontrollably, producing abnormal protein. Over time, the disease can cause the marrow to become crowded, reducing normal blood cell production. The excess plasma cells may form tumors in bone, leading to weakening of the skeleton. The abnormal protein can accumulate in the blood and kidneys, affecting their function. As the condition advances, the number of abnormal cells generally increases, leading to further disruption of normal blood and bone health.