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Phase II Study of Teclistamab Plus Pomalidomide in Patients with Relapsed/Refractory Multiple Myeloma After 1–3 Prior Therapies

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What is this trial about?

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

The study focuses on adults with relapsed or refractory Multiple myeloma (often abbreviated as RRMM), a blood cancer that returns after previous treatments. The investigational regimen combines the antibody therapy teclistamab, given as a subcutaneous injection, with the oral drug pomalidomide. Both medicines are intended to work together to target cancer cells that have become resistant to earlier therapies such as lenalidomide and anti‑CD38 therapy.

The primary aim is to evaluate how well this combination works in controlling the disease. Participants receive the injection and the capsule on a repeated schedule, typically every few weeks, and are followed for several months with regular doctor visits, blood tests, and imaging to check for disease activity and any side effects. The study continues until a predefined number of treatment cycles are completed or if a participant experiences significant toxicity that requires stopping the therapy.

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

    Baseline assessment

    After enrollment, a series of tests are performed to record the current health status and disease characteristics. these results serve as the reference point for all future measurements.

  2. Step 2

    First dose of <b>teclistamab</b>

    The study medication teclistamab is given as a subcutaneous injection (injection under the skin). the dose is 1 mg/kg (one milligram per kilogram of body weight). this initial injection marks the start of the treatment period.

  3. Step 3

    Start of <b>pomalidomide</b> oral capsules

    On the same day or as directed, the patient begins taking pomalidomide capsules. each capsule contains 1 mg (one milligram) of the active substance and is taken by mouth. the exact schedule (for example, daily) follows the study protocol.

  4. Step 4

    Continuous treatment cycles

    Treatment is organized into repeated periods called cycles. each cycle includes a dose of teclistamab given by subcutaneous injection and the daily intake of pomalidomide capsules. the dosing amount remains the same for every cycle.

    The study plans for up to 12 cycles, which corresponds to the primary evaluation point after approximately one year of therapy.

  5. Step 5

    Regular monitoring visits

    Throughout the treatment period, the patient attends scheduled visits. during these visits, health professionals check for side effects, measure disease response, and record any changes in symptoms or quality of life.

    Laboratory tests and imaging may be performed to assess the effectiveness of the combination therapy.

  6. Step 6

    Evaluation after 12 <b>cycles</b>

    At the end of the 12th cycle, a comprehensive assessment is carried out. this includes measuring progression‑free survival (the time the disease does not get worse) and checking for complete response without detectable disease.

  7. Step 7

    Optional continuation to 24 <b>cycles</b>

    If the patient continues to meet study criteria, treatment may be extended for up to 24 cycles. additional evaluations are performed to determine long‑term response and safety.

  8. Step 8

    Final follow‑up

    After the last treatment cycle, the patient undergoes a final follow‑up visit. this includes a last set of assessments to document overall outcome, any late side effects, and overall survival.

Who can join the trial?

14 criteria

  • Age requirement: You must be at least 18 years old (or the legal adult age in your country) when you sign the consent form.
  • Diagnosis of multiple myeloma: You must have a confirmed diagnosis of multiple myeloma, a type of blood cancer, based on standard medical criteria, and have measurable disease shown by specific blood test levels.
  • Relapsed or refractory disease: Your cancer must have either come back after previous treatment (relapsed) or not responded to previous treatment (refractory) according to standard definitions.
  • Prior treatments: You must have received 1 to 3 previous treatment plans, including at least two cycles of an anti‑CD38 monoclonal antibody (a type of targeted therapy) and at least two cycles of lenalidomide (a medication used for this cancer).
  • Progressive or non‑responsive disease: Your doctor must determine that your disease is getting worse or did not respond to the most recent therapy.
  • ECOG performance status: Your overall health must be rated as 0, 1, or 2 on the ECOG scale, meaning you are fully active (0) or able to care for yourself but unable to do work activities (1‑2).
  • Laboratory values: You must have blood test results within the required ranges, including hemoglobin at least 8.0 g/dL, platelets at least 75 × 10⁹/L (or 50 × 10⁹/L if many bone‑marrow cells are cancerous), white‑blood‑cell count (ANC) at least 1.0 × 10⁹/L, liver enzymes (AST/ALT) no more than 2.5 times the normal limit, kidney function (eGFR) 30 mL/min or higher, bilirubin no more than 1.5 times normal, and calcium no higher than 14 mg/dL.
  • Pregnancy testing for women: Women who could become pregnant must have a negative pregnancy test within 14 days before the first dose and another negative test within 24 hours before treatment, and must agree to continue pregnancy testing during the study.
  • Contraception for women: Women who could become pregnant must either be unable to become pregnant or must use a highly effective birth‑control method and keep using it until six months after the last dose.
  • Egg donation restriction for women: Women must agree not to donate, freeze, or store eggs for reproductive purposes during the study and for six months after the last dose.
  • Condom use for men: Men must wear a condom (with or without spermicide) during any sexual activity that could result in ejaculation reaching another person, for the whole study period and for three months after the last dose. If the partner could become pregnant, she must also use effective contraception unless the man has had a vasectomy (but the man still must use a condom).
  • Sperm donation restriction for men: Men must agree not to donate sperm for reproductive purposes during the study and for three months after the last dose.
  • Informed consent: You must sign an informed consent form (or have a legally authorized representative sign) showing that you understand the study purpose and procedures and agree to take part.
  • Willingness to follow study rules: You must be willing and able to follow any lifestyle restrictions and study procedures described in the protocol.

Who cannot join the trial?

15 criteria

  • Had any previous treatment that specifically targets BCMA (a protein on myeloma cells).
  • Has a serious allergy, severe reaction, or intolerance to the study drug, its ingredients, or to dexamethasone (a steroid medication).
  • Received any of the following cancer treatments too recently: targeted or epigenetic drugs, experimental drugs or devices, investigational vaccines, monoclonal antibodies, chemotherapy, proteasome inhibitors, immunomodulatory drugs, radiation therapy, gene‑modified cell therapy (such as CAR‑T cells), plasmapheresis, high‑dose steroids, or a stem cell transplant (all within the time limits listed in the study).
  • Received a live, weakened‑virus vaccine within the past 4 weeks or plans to receive one during the study.
  • Shows signs that the myeloma has spread to the brain or spinal fluid (called CNS involvement or meningeal disease).
  • Has any of these rare blood‑cell disorders: Waldenström’s macroglobulinemia, POEMS syndrome, or light‑chain amyloidosis.
  • Has an ongoing blood‑cell problem called myelodysplastic syndrome, or any other cancer that is still active or likely to come back and needs treatment, except for certain cured cancers (such as early‑stage skin cancer, non‑muscle invasive bladder cancer, certain breast or prostate cancers, etc.).
  • Had a stroke, a brief “mini‑stroke” (transient ischemic attack), or a seizure within the last 6 months.
  • Has any of the following heart problems: unstable chest pain (angina) or severe heart failure (class III‑IV), a heart attack or heart bypass surgery within 6 months, dangerous heart rhythm problems, uncontrolled heart rhythm or abnormal ECG, or a heart‑pumping ability (left‑ventricular ejection fraction) less than 40%.
  • Underwent major surgery or suffered a serious injury within the past 2 weeks, has not fully recovered from such surgery, or plans to have major surgery while participating in the study (minor procedures under local anesthesia are allowed).
  • Has a medical or psychiatric condition that could interfere with the study or be unsafe, such as active lung disease, ongoing infections that need antibiotics, uncontrolled autoimmune disease, severe substance abuse, dementia, inability to follow study instructions, or recent fluid build‑up in the lungs or abdomen that required drainage.
  • Tests positive for hepatitis B surface antigen (indicating active infection) or has detectable hepatitis B DNA in the blood.
  • Has an active hepatitis C infection (detectable hepatitis C RNA in the blood).
  • Is HIV‑positive and meets any of these: a history of AIDS‑defining illnesses, a low CD4 cell count (<350 cells/mm³), detectable HIV viral load, not on effective antiretroviral therapy, changed HIV medicines within 6 months, or taking HIV drugs that could interfere with the study treatment.
  • Any condition that the doctor believes would make participation unsafe, could harm the patient’s health, or might affect the study results.
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Investigated drugs

  • teclistamab

    is a medicine given as a small injection under the skin. It is a type of immunotherapy that connects the body’s immune cells to the cancer cells, helping the immune system recognize and kill the multiple myeloma cells. In this study, it is tested to see how well it works when used together with another drug.

  • pomalidomide

    is an oral capsule that you swallow. It belongs to a group of drugs called immunomodulatory agents, which can slow the growth of cancer cells and also help the immune system fight the disease. In this trial, it is taken together with the injection to see if the combination improves treatment results for patients with relapsed or refractory multiple myeloma.

What is already known about the treatment

  • teclistamab

    This investigational medication is given as a subcutaneous injection of a clear solution, dosed by body weight. It is currently being studied in clinical trials for the treatment of relapsed or refractory multiple myeloma. Teclistamab works by linking a protein on myeloma cells (BCMA) to T‑cells (CD3), directing the immune system to attack the cancer. It belongs to the class of bispecific T‑cell‑engaging antibodies.

  • pomalidomide

    This approved drug is taken orally as a hard capsule, usually at a fixed milligram dose. It is used to treat relapsed or refractory multiple myeloma, often after other therapies have failed. Pomalidomide binds to the protein cereblon, altering the activity of immune cells and reducing blood vessel growth that supports tumors. It is classified as an immunomodulatory imide drug (IMiD).

Investigated diseases

Multiple myeloma - Multiple myeloma is a cancer of plasma cells that live in the bone marrow. It causes abnormal cells to build up, crowding out normal blood cells. Over time, patients may develop bone pain, anemia, kidney problems, and increased infections. The disease often progresses slowly at first, but can become more aggressive, leading to more symptoms. In relapsed/refractory cases, the disease returns after previous treatments and may spread further.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522114-23-00Protocol code64007957MMY2022Estimated enrolment50 patientsSponsorOdense University Hospital

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