Testing the efficacy of teclistamab vs other drugs for relapsed or refractory multiple myeloma treatment

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    What is this study about?

    The study is evaluating a treatment for a blood cancer known as multiple myeloma. Two different treatments are being compared to assess their effectiveness in both slowing down the disease and minimizing side effects. The first treatment involves a single medicine called teclistamab, while the second offers a choice between two combinations of multiple medicines (either PVd – pomalidomide, bortezomib, dexamethasone or Kd – carfilzomib, dexamethasone). Both treatments have been previously administered to individuals with similar conditions. Individuals who have undergone prior treatment, including the use of an anti-CD38 monoclonal antibody and lenalidomide, but experienced a recurrence or lack of resolution of the disease, are eligible to participate in this study. The objective is to determine the duration it takes for the disease to progress under different treatments. Additionally, the study will monitor changes in health and potential medication-related issues through regular check-ups.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Salzburg , Austria

      Vienna , Austria

      Brasschaat , Belgium

      Haine-St-Paul , Belgium

      Kortrijk , Belgium

      Leuven , Belgium

      Liege , Belgium

      Brno , Czechia

      Olomouc , Czechia

      Ostrava – Poruba , Czechia

      Praha 2 , Czechia

      Aalborg , Denmark

      Aarhus , Denmark

      Copenhagen , Denmark

      Herning , Denmark

      Odense C , Denmark

      Vejle , Denmark

      AMIENS cedex 1 , France

      Caen cedex 9 , France

      Grenoble , France

      Le Mans , France

      Lille , France

      Montpellier , France

      Nantes Cedex 1 , France

      Paris , France

      Paris , France

      Paris , France

      Toulouse , France

      Vandu0153uvre-lu00e8s-Nancy , France

      Cottbus , Germany

      Dresden , Germany

      Greifswald , Germany

      Hamburg , Germany

      Heidelberg , Germany

      Tu00fcbingen , Germany

      Ulm , Germany

      Zwickau , Germany

      Athens Attica , Greece

      Patra , Greece

      Thessaloniki , Greece

      Bologna , Italy

      Milano , Italy

      Palermo , Italy

      Pisa , Italy

      Reggio Emilia , Italy

      Roma , Italy

      Siena , Italy

      Turin , Italy

      Udine , Italy

      Varese , Italy

      Amersfoort , Netherlands

      Amsterdam , Netherlands

      Groningen , Netherlands

      Utrecht , Netherlands

      Gdansk , Poland

      Katowice , Poland

      Kielce , Poland

      Lublin , Poland

      Almada , Portugal

      Lisbon , Portugal

      Porto , Portugal

      Vila Nova de Gaia , Portugal

      Hospitalet de Llobregat , Spain

      Jerez de la Frontera , Spain

      Leon , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Murcia , Spain

      Oviedo , Spain

      Palma de Mallorca , Spain

      Pontevedra , Spain

      Pozuelo de Alarcon , Spain

      Valu00e8ncia , Spain

      Falun , Sweden

      Helsingborg , Sweden

      Uppsala , Sweden

      Aberdeen , United Kingdom

      Colchester , United Kingdom

      Liverpool , United Kingdom

      London , United Kingdom

      Norwich , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The clinical trial includes the following steps for patients:

      1. Screening Phase: Safety will be assessed by physical examinations, neurologic examinations, Eastern Cooperative Oncology Group (ECOG) performance status, clinical laboratory tests, vital signs, and adverse event (AE) monitoring.
      2. Treatment Phase: Participants will either receive teclistamab monotherapy, which will be administered subcutaneously, or they will receive a combination of drugs based on the principal investigator’s choice. If not teclistamab, patients may receive Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd).
      3. Follow-up Phase: The follow-up phase is implied as part of the safety assessments and evaluation of efficacy outcomes that will last for the duration of the trial.

      The overall duration of the study will be up to 9 years.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you must have a documented diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) diagnostic criteria.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study, along with explanations of the medical terms:

      Inclusion Criteria:

      1. Documented diagnosis of multiple myeloma:
        • Diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria. IMWG criteria include evidence of plasma cells in the bone marrow, presence of a monoclonal protein, and signs of organ damage that can be attributed to the underlying plasma cell proliferative disorder.
        • Measurable disease at screening defined by one of the following:
          • Serum M-protein level ≥0.5 grams per deciliter (g/dL).
          • Urine M-protein level ≥200 milligrams (mg) per 24 hours.
          • Serum immunoglobulin free light chain ≥10 mg/dL and an abnormal serum immunoglobulin kappa lambda free light chain ratio.
      2. Previous therapy for multiple myeloma: You need to have received 1 to 3 prior lines of antimyeloma therapy. This must include at least two consecutive cycles of an anti-CD38 monoclonal antibody and two consecutive cycles of lenalidomide. The CD38 monoclonal antibody is a type of targeted therapy that attaches to CD38 proteins found on the surface of myeloma cells. Lenalidomide is an immunomodulatory drug that affects the immune system and can help control myeloma.
      3. Documented evidence of disease progression: There must be documented proof based on the IMWG criteria that the disease has progressed or there was a failure to respond to the last line of therapy.
      4. Performance status: You must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
        • The ECOG performance status is a scale used to assess how a patient’s disease is progressing, how the disease affects the daily living abilities of the patient, and determines appropriate treatment and prognosis. It ranges from 0 to 5 with 0 being fully active without restrictions, 1 restricted in physically strenuous activity but ambulatory, and 2 capable of all self-care but unable to carry out any work activities.
      5. Reproductive status for female participants: Female participants must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in the study or within 6 months after the last dose of study treatment.
      6. Lifestyle adherence: Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria with Explanations:

      1. Previous BCMA-directed therapy: You cannot participate if you have received treatment targeting B cell maturation antigen (BCMA), which is a protein that is generally found on the surface of B cells, including malignant multiple myeloma cells.
      2. Previous pomalidomide therapy: You are not eligible for PVd control therapy if you have previously been treated with pomalidomide, which is a medication used in the treatment of multiple myeloma.
      3. Criteria for bortezomib retreatment: If you are not suitable for re-treatment with bortezomib (a proteasome inhibitor used for multiple myeloma treatment), you cannot receive PVd control therapy.
      4. Allergies/hypersensitivity to pomalidomide or bortezomib: If you have life-threatening allergies or intolerance to these medications, you cannot receive PVd control therapy.
      5. Peripheral neuropathy: If you have Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy, as defined by NCI-CTCAE Version 5.0, you are ineligible. Peripheral neuropathy is a nerve condition that causes weakness, numbness, and pain, usually in the hands and feet.
      6. Use of strong CYP3A4 inducers: If you have received a strong inducer of cytochrome P450 (CYP) 3A4, which is a protein involved in drug metabolism, within 5 half-lives before randomization, you cannot participate. These substances may significantly lower the plasma concentrations of drugs metabolized by this enzyme.

      These criteria ensure that the safety of participants is prioritized and that the study results are not confounded by previous treatments or medical conditions.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study, along with a brief description of each active substance, are:

      1. Teclistamab (JNJ-64007957): A bispecific antibody that targets the CD3 receptor on T cells and the B cell maturation antigen (BCMA) to bring T cells into proximity with BCMA-positive cells, leading to T-cell activation and subsequent lysis of these cells.
      2. Pomalidomide: A third-generation immunomodulatory imide drug (IMiD) that has both direct tumoricidal effects and immune-enhancing capabilities.
      3. Bortezomib: A proteasome inhibitor that interferes with protein turnover in cells, which leads to apoptosis, particularly in cancer cells.
      4. Dexamethasone: A corticosteroid medication used to reduce inflammation and suppress the immune system, commonly used in combination with other drugs for the treatment of multiple myeloma.
      5. Carfilzomib: A second-generation proteasome inhibitor that works similarly to Bortezomib, used to treat multiple myeloma by causing cell death.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances in the clinical trial are known to medicine and have been described in the medical literature. Below is the list of substances and their descriptions:

      1. Teclistamab (JNJ-64007957): Teclistamab is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the CD3 receptor on T cells and B cell maturation antigen (BCMA). It draws CD3 positive T cells in close proximity to BCMA positive cells, causing T-cell activation and subsequent lysis of the BCMA positive cells.
      2. Pomalidomide: Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) known for its potent, direct tumoricidal and immune-enhancing effects.
      3. Carfilzomib: Carfilzomib is a second-generation proteasome inhibitor that blocks proteasome activity leading to a disruption in protein turnover and induction of apoptosis in cancer cells.
      4. Bortezomib: Not specifically detailed in the provided text regarding its novelty but it is an established proteasome inhibitor used in multiple myeloma treatment.
      5. Dexamethasone: Dexamethasone is a well-known synthetic glucocorticoid with anti-inflammatory and immunosuppressant properties. It is not specifically discussed in the text as a novel drug, suggesting that it is a standard treatment option.

      Each of these substances has been utilized in various capacities in the treatment of multiple myeloma or other conditions and have corresponding literature documenting their use and effects.


      Study ID

      CT-EU-00041959

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III