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Cevostamab, Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma Previously Treated with 1‑3 Lines of Therapy

Verified siteRegistered drugNo placebo
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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 bone‑marrow cells that make antibodies. The trial tests a new antibody called Cevostamab given together with the oral medicines pomalidomide and dexamethasone. The purpose is to find out whether this three‑drug mix works better and is safe compared with the usual treatments that may include drugs such as elotuzumab, carfilzomib or daratumumab. Researchers will look at two main results: the proportion of patients who achieve a very deep level of disease control called MRD-negative CR, which means no cancer cells are found by a sensitive test called NGS in a bone‑marrow sample, and the length of time patients stay free of disease worsening, known as PFS.

Participants are randomly assigned to receive either the new combination or the standard regimen; the new drugs are given by IV infusion on scheduled days while the oral pills are taken at home. The standard‑of‑care arm receives the physician‑chosen drugs (such as elotuzumab, carfilzomib or daratumumab) using the usual dosing routes. Throughout the study, blood work, imaging and a bone‑marrow test reviewed by an independent review committee (IRC) using criteria from the International Myeloma Working Group (IMWG) are performed to follow the disease. Additional outcomes include measures such as overall survival (OS), very good partial response (VGPR), overall response rate (ORR), time to first response (TTR), time to deepest response (TTBR) and duration of response (DOR). Safety is checked with standard grading systems from the NCI (CTCAE) and the ASTCT for side‑effects such as cytokine release syndrome (CRS), immune‑cell neurotoxicity (ICANS) and severe inflammation syndromes (HLH, IEC-HS). Patients also complete quality‑of‑life questionnaires from the EORTC (QLQ-MY20, QLQ-C30) and the FACTG tool, and report symptoms using the PRO-CTCAE system during regular visits until the disease progresses or the study ends.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After you join the study, you are assigned to one of two treatment groups. one group receives the test combination called cevostamab plus pomalidomide and dexamethasone. the other group receives the standard of care, which may include medicines such as elotuzumab, carfilzomib, daratumumab, and dexamethasone.

    Your baseline health information, including blood tests and a bone‑marrow sample, is collected before treatment begins.

  2. Step 2

    Baseline assessments

    A bone‑marrow aspirate is performed to evaluate disease status using next‑generation sequencing. this provides the reference for later mr d‑negative cr assessments.

    Additional laboratory tests, vital‑sign measurements, and questionnaires about symptoms and quality of life are completed.

  3. Step 3

    Start of study medication

    If you are in the test group, you begin receiving cevostamab by iv infusion. the medication is given as a concentrate that is mixed with a solution and delivered through a needle in a vein.

    You also start oral pomalidomide tablets and oral or iv infusion dexamethasone, according to the study schedule.

    If you are in the standard‑of‑care group, you receive the assigned medicines (for example, elotuzumab or carfilzomib by iv infusion, daratumumab by subcutaneous injection, and dexamethasone by oral or iv infusion) as described in the protocol.

  4. Step 4

    Regular treatment cycles

    Treatment is given in repeated cycles. each cycle includes the scheduled doses of the study drugs and may last several weeks, as defined by the protocol.

    The same medicines are taken in each cycle unless a dose adjustment is required because of side effects.

  5. Step 5

    Monitoring visits and tests

    During each cycle you attend clinic visits for safety monitoring. blood samples are drawn to check blood counts, organ function, and drug levels.

    Your doctor evaluates any side effects using standardized grading systems. dose interruptions, reductions, or discontinuation may be recommended based on these evaluations.

    Periodic imaging or bone‑marrow assessments are performed to track disease response, including a scheduled mr d‑negative cr assessment at 9 months.

  6. Step 6

    Assessment of response

    Responses are classified using criteria such as complete response, very good partial response, partial response, and stable disease. these are determined by the independent review committee.

    If a response is achieved, the time to first response and the depth of response are recorded.

  7. Step 7

    Treatment continuation or discontinuation

    Treatment continues until disease progression, unacceptable toxicity, or completion of the planned number of cycles, as defined by the study.

    If disease progression is observed or if serious side effects occur, treatment may be stopped and subsequent care is arranged.

  8. Step 8

    Post‑treatment follow‑up

    After stopping study medication, you enter a follow‑up period. periodic visits are scheduled to monitor long‑term safety, survival, and disease status.

    Follow‑up assessments may include blood tests, imaging, and questionnaires about symptoms and quality of life.

Who can join the trial?

10 criteria

  • Agree to have the planned tests and procedures, which include a bone marrow biopsy (a small sample taken from the inside of a bone) and an aspirate (a fluid sample from the bone marrow).
  • Have an ECOG Performance Status of 0 or 1 when screened and right before starting treatment; people with a score of 2 only because of myeloma‑related pain are also allowed. (ECOG measures how well you are able to carry out daily activities, where 0 = fully active and 1 = restricted in physically strenuous activity.)
  • Be expected to live at least 12 more weeks.
  • Have a diagnosis of multiple myeloma (MM) that meets the official criteria set by the International Myeloma Working Group (IMWG).
  • Show measurable disease, meaning at least one of the following lab results:
    • Blood test showing serum M‑protein (a protein made by myeloma cells) of 0.5 g/dL (5 g/L) or higher,
    • Urine test showing urine M‑protein of 200 mg in 24 hours or more, or
    • If the myeloma is a “light chain” type, a blood test showing free light chains above 10 mg/dL and an abnormal ratio of the two types of light chains (kappa/lambda) that is less than 0.26 or greater than 1.65.
    • Have received one to three previous treatment courses (called “lines of therapy”) that included at least two back‑to‑back cycles of:
      • a regimen containing an anti‑CD38 therapy (a drug that targets a protein on myeloma cells),
      • a regimen containing lenalidomide (a medicine that helps the immune system fight myeloma), and
      • for patients in the United States, a regimen that includes a proteasome inhibitor (PI)

Who cannot join the trial?

6 criteria

  • You cannot join the study if you have a known history of amyloidosis, a disease where abnormal protein builds up in body tissues; this includes any positive test such as a Congo Red stain (a lab test that shows the protein) or a serum amyloid P component scan (an imaging test that looks for the protein).
  • You cannot join if you have tumor lesions that are located very close to vital organs (important organs like the heart, lungs, liver, or brain) and could cause a sudden worsening of health (called decompensation) if the tumor temporarily gets larger (a “tumor flare”).
  • You cannot join if you have plasma cell leukemia (a rare blood cancer) or if the number of abnormal plasma cells in your blood is higher than 500 cells per microliter or makes up more than 5 % of your white blood cells.
  • You cannot join if you have Waldenström’s macroglobulinemia (a type of blood cancer) or POEMS syndrome (a rare disorder that affects many body systems).
  • You cannot join if you are unable to take medicines that prevent blood clots (called thromboprophylaxis) or if you have a medical reason (a contraindication) that makes taking those medicines unsafe.
  • You cannot join if you have a known history of interstitial lung disease, which is a group of lung conditions that cause scarring and make breathing difficult.
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Investigated drugs

  • Cevostamab

    is an investigational medicine given by IV infusion. It is designed to help the immune system recognize and attack myeloma cancer cells. In this study it is being tested together with other drugs to see if it improves treatment results for patients who have already had other therapies.

  • Pomalidomide

    is an oral medication that works by modifying the activity of the immune system and directly inhibiting the growth of myeloma cells. It is used in combination with other drugs to try to control the disease and keep it from getting worse.

  • Dexamethasone

    is a steroid that is taken either by mouth or given through an IV. It helps reduce inflammation and can kill cancer cells, and it is often added to other myeloma treatments to improve their effectiveness.

  • Elotuzumab

    is a medication given by IV infusion that helps the immune system target myeloma cells. It works by attaching to a protein on the cancer cells and signaling immune cells to destroy them.

  • Carfilzomib

    is an IV infusion drug that blocks a process cancer cells need to survive, leading to their death. It is commonly used as part of standard treatment regimens for multiple myeloma.

  • Daratumumab

    is given by subcutaneous injection and works by binding to a protein on myeloma cells, marking them for destruction by the immune system. It is a standard therapy option for patients with multiple myeloma.

What is already known about the treatment

  • Cevostamab

    Given by IV infusion as a concentrate that is mixed for injection, Cevostamab is an experimental bispecific antibody that is still being studied in clinical trials for multiple myeloma. It works by linking T‑cells to cancer cells, helping the immune system kill the tumor. The drug is classified as a bispecific T‑cell engager. It is being investigated as a new treatment option for patients who have already received other therapies.

  • Dexamethasone

    Available as oral tablets and IV infusion, dexamethasone is a well‑known corticosteroid that has been used for many decades in a wide range of medical conditions. In multiple myeloma it reduces inflammation and suppresses the immune response, which helps control disease symptoms. It belongs to the glucocorticoid class of drugs and is a standard part of many myeloma treatment regimens.

  • Elotuzumab

    Administered by IV infusion as a solution for injection, elotuzumab is an approved monoclonal antibody for multiple myeloma. It targets the SLAMF7 protein on myeloma cells and activates natural killer cells to attack the cancer. The medication is classified as an immunostimulatory antibody and is used together with other drugs in patients whose disease has returned.

  • Carfilzomib

    Given by IV infusion, carfilzomib is an approved proteasome inhibitor used to treat multiple myeloma. It blocks the cell’s protein‑degrading system, causing cancer cells to build up toxic proteins and die. This drug belongs to the proteasome‑inhibitor class and is typically used after other treatments have failed.

  • Pomalidomide

    Taken orally as a tablet, pomalidomide is an approved immunomodulatory drug for multiple myeloma that has progressed after other therapies. It modifies the activity of immune cells and also stops new blood vessels from forming around the tumor. The medication is classified as an IMiD (immunomodulatory imide drug) and is commonly combined with dexamethasone.

  • Daratumumab

    Delivered by subcutaneous injection, daratumumab is an approved monoclonal antibody that targets the CD38 protein on myeloma cells. By binding to CD38, it flags the cancer cells for destruction by the immune system. It is classified as a CD38‑directed antibody and is used in many standard multiple myeloma treatment plans.

Investigated diseases

Multiple Myeloma - Multiple Myeloma is a cancer that starts in plasma cells, a type of white blood cell found in the bone marrow. Abnormal plasma cells grow and multiply, producing excess abnormal proteins. These cells can push out normal blood cells, leading to anemia, infections, and weakened bones. As the disease advances, it may cause bone lesions, kidney problems, and higher levels of the abnormal proteins. The condition typically progresses in stages, with more cells and symptoms appearing over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524028-23-00Protocol codeCO46096Estimated enrolment384 patientsSponsorF. Hoffmann-La Roche AG

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