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Plasma cell myeloma refractory – Trials in Disease

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Clinical Trials for Plasma Cell Myeloma Refractory

There are currently 15 ongoing clinical trials investigating new treatments for plasma cell myeloma refractory (also known as refractory multiple myeloma), a type of blood cancer that does not respond to standard treatments. These trials are being conducted across Europe, testing various drug combinations, cell therapies, and targeted medications to help patients whose disease has become resistant to previous treatments.

Clinical trial locations

Study Comparing Anitocabtagene Autoleucel with Standard Treatment for Patients with Relapsed or Refractory Multiple Myeloma

This trial is exploring an innovative cell therapy approach called anitocabtagene autoleucel, which uses a patient’s own modified immune cells to fight the cancer. The study compares this new treatment with standard medication combinations.

Inclusion criteria: Patients must have documented multiple myeloma that has progressed within 12 months of their last treatment. They must have received 1 to 3 previous treatments, including an immunomodulatory drug and an anti-CD38 monoclonal antibody. Patients need measurable disease with specific levels of M-protein in blood or urine, or serum free light chain of at least 10 mg/dL. They must be aged 18 or older, have an ECOG performance status of 0 or 1, and be candidates for at least one of the standard therapy regimens being tested.

Exclusion criteria: The trial excludes patients who have not been properly diagnosed with relapsed or refractory disease, those who have not received the required 1 to 3 previous treatment lines, and those who have not been treated with both an immunomodulatory drug and an anti-CD38 monoclonal antibody.

Trial focus: The study aims to determine whether anitocabtagene autoleucel can help patients live longer without disease progression compared to standard treatments. It will monitor participants over time to assess response, including progression-free survival and overall survival rates, while also evaluating side effects and quality of life impacts.

Investigational drug: Anitocabtagene autoleucel is a CAR T-cell therapy where a patient’s own immune cells are collected, modified in a laboratory to better recognize and attack cancer cells, and then infused back into the patient. This approach represents a type of immunotherapy designed to harness the body’s immune system to fight cancer.

Study Comparing Elranatamab to Drug Combinations for Patients with Relapsed/Refractory Multiple Myeloma After Anti-CD38 Therapy

This study evaluates elranatamab as a single treatment option compared to various combination therapies for patients who have already received anti-CD38 directed therapy.

Inclusion criteria: Participants must be 18 years or older with a prior diagnosis of multiple myeloma. They must have received at least one but no more than four previous treatments, including at least two cycles each of an anti-CD38 antibody and lenalidomide. The disease must show evidence of progression or lack of response to the last treatment. Patients need measurable disease with specific protein levels, corrected serum calcium of 14 mg/dL or less, adequate bone marrow function, and an ECOG performance status of less than 2.

Exclusion criteria: The study excludes patients with cancers other than multiple myeloma, those outside the specified age range, patients unable to follow study procedures or with conditions making participation unsafe, pregnant or breastfeeding women, those who recently participated in other clinical trials, and patients taking medications that could interfere with study treatments.

Trial focus: The trial aims to compare how well elranatamab works as a monotherapy against combination treatments including elotuzumab, pomalidomide, and dexamethasone, or pomalidomide, bortezomib, and dexamethasone, or carfilzomib and dexamethasone. The study will measure progression-free survival and overall survival rates to determine which approach is most effective.

Investigational drug: Elranatamab is administered as an injection and targets specific proteins on cancer cells to help the immune system recognize and destroy them. It is classified as a monoclonal antibody, representing a type of targeted cancer therapy.

Study Comparing Mezigdomide, Bortezomib, and Dexamethasone with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

This trial compares two different treatment combinations to determine which is more effective and safer for managing relapsed or refractory multiple myeloma.

Inclusion criteria: Patients must have confirmed multiple myeloma with measurable disease showing specific protein levels in blood or urine. They should have received 1 to 3 previous treatments and must have been treated with lenalidomide in the past. Patients must have shown at least minimal improvement from at least one previous treatment and experienced disease worsening during or after their last treatment. They must have an ECOG performance status of 0, 1, or 2, indicating ability to perform daily activities.

Exclusion criteria: The trial excludes patients with cancers other than relapsed or refractory multiple myeloma, those outside the specified age range, patients unable to follow study procedures or take medications as required, those with certain health conditions that might interfere with the study, pregnant or breastfeeding women, those who recently participated in other trials, patients with allergies to study medications, and those who have not recovered from previous treatments or surgeries.

Trial focus: The study evaluates how long patients can live without disease progression while taking either mezigdomide combined with bortezomib and dexamethasone, or pomalidomide combined with bortezomib and dexamethasone. It will monitor participants’ health and response, assess side effects, and measure overall response and survival rates.

Investigational drugs: Mezigdomide is an experimental immunomodulatory drug being tested for its effectiveness in stopping cancer growth. Bortezomib is a proteasome inhibitor that interferes with cancer cell growth, leading to their destruction. Dexamethasone is a corticosteroid that reduces inflammation and is used to enhance cancer treatment effectiveness. Pomalidomide is an immunomodulatory agent that helps the immune system attack cancer cells.

Study of Linvoseltamab in Adults with Relapsed or Refractory Multiple Myeloma

This trial tests linvoseltamab, a bispecific antibody designed to target specific proteins on cancer cells to help the immune system fight the cancer more effectively.

Inclusion criteria: Patients must have confirmed active multiple myeloma with an ECOG performance status of 0 or 1. The myeloma must be measurable according to specific criteria. For different phases of the study, patients must have tried various numbers of previous treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies, with the disease either progressing or not responding. If patients previously received BCMA-directed CAR-T therapy, they must have shown improvement and had at least 60 days since treatment.

Exclusion criteria: The study excludes patients who have not experienced disease return or lack of response, those who haven’t tried at least three different treatments, patients not resistant to the three specific treatment types mentioned, those who haven’t previously relapsed after BCMA-directed CAR-T therapy, patients outside the specified age range, and those belonging to vulnerable populations.

Trial focus: The study has two phases: the first finds the best tolerable dose through intravenous infusion, while the second evaluates how well the medication controls cancer. Some patients may receive pre-treatment targeting IL-6R to help manage side effects. The goal is to determine if linvoseltamab can be a safe and effective treatment option.

Investigational drug: REGN5458 (linvoseltamab) is a bispecific antibody that targets BCMA and CD3 proteins, engaging the immune system to attack cancer cells. It’s administered either intravenously or subcutaneously, and the trial is exploring optimal dosing and effectiveness.

Study of Selinexor, Dexamethasone, and Bortezomib for Patients with Refractory Multiple Myeloma

This study focuses on testing medication combinations for two specific forms of treatment-resistant multiple myeloma: penta-refractory and triple-class refractory.

Inclusion criteria: Participants must be at least 18 years old and have signed informed consent. They must have measurable multiple myeloma with specific protein levels in blood or urine or abnormal free light chain levels. For penta-refractory patients, they must have received at least 4 previous treatments and be resistant to at least 2 proteasome inhibitors, 2 immunomodulatory drugs, and 1 anti-CD38 monoclonal antibody. For triple-class refractory patients, 1 to 5 previous treatments with resistance to at least one of each drug class is required. Patients need an ECOG performance status of 2 or less and must agree to use effective contraception.

Exclusion criteria: The trial excludes patients without the specified types of refractory myeloma, those outside the age range, patients unable to follow procedures or take medications properly, those with interfering medical conditions, pregnant or breastfeeding women, and vulnerable populations unable to provide informed consent.

Trial focus: The study evaluates different combinations of selinexor, dexamethasone, and bortezomib at various doses to determine which works best for managing these challenging forms of multiple myeloma. Participants will be monitored to assess disease response and treatment effectiveness.

Investigational drugs: Selinexor blocks certain proteins in cancer cells to stop their growth. Dexamethasone is a steroid that reduces inflammation and enhances other cancer treatments. Bortezomib is a proteasome inhibitor that interferes with cancer cell growth, often used when other treatments have failed.

Study on the Safety and Effectiveness of BCMACP03 for Patients with Relapsed or Refractory Multiple Myeloma

This trial evaluates a new cell therapy called BCMACP03, which involves specially modified anti-BCMA CAR T cells created using lentivirus to modify patients’ own T cells.

Inclusion criteria: Participants must be at least 18 years old with signed informed consent and agree to use highly effective contraception for at least 12 months after treatment. They must have documented multiple myeloma according to specific guidelines, with disease that has returned or not responded to at least two previous treatments including specific drug types and therapies. Patients need measurable disease, performance status of 0 or 1, and adequate bone marrow, kidney, liver, and lung function. Women of childbearing potential must have negative pregnancy tests.

Exclusion criteria: The study excludes patients without relapsed or refractory multiple myeloma, those outside the specified age range, and vulnerable populations.

Trial focus: The study has two phases: first, determining the safety and appropriate dose of GLPG5301, and second, evaluating how well it works in reducing cancer. Throughout the trial, participants receive treatment through intravenous infusion, with regular monitoring for effectiveness and side effects, particularly eye health.

Investigational drug: GLPG5301 uses anti-BCMA CAR T cells, where patients’ immune cells are collected, modified to recognize and attack cancer cells through BCMA protein targeting, and then infused back. This immunotherapy approach is being tested for feasibility and safety in treatment-resistant cases.

Comparing CT-P44 and Darzalex Faspro with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma

This double-blind study compares CT-P44 to Darzalex Faspro, both containing daratumumab, used in combination with lenalidomide and dexamethasone.

Inclusion criteria: Patients must be 18 years or older with diagnosed multiple myeloma that has relapsed or is refractory. They must have shown positive response to at least one previous treatment and experienced disease progression during or after their most recent therapy. They should have received at least 1 but no more than 3 previous treatments.

Exclusion criteria: The trial excludes patients with prior daratumumab or anti-CD38 treatment, active plasma cell leukemia, severe allergies to similar medications, active infections, major recent surgery, recent participation in other trials, significant heart problems, severe liver or kidney issues, active untreated cancer, pregnancy or breastfeeding, inability to use contraception, mental conditions interfering with procedures, recent stem cell transplant, or recent use of experimental treatments.

Trial focus: The study evaluates how well CT-P44 compares to Darzalex Faspro when combined with lenalidomide and dexamethasone. Both medications are given by subcutaneous injection for up to 104 weeks, with regular monitoring of treatment effectiveness and side effects. The primary assessment occurs at 24 weeks to evaluate overall response.

Investigational drugs: CT-P44 is being tested as a biosimilar to Darzalex Faspro. Darzalex Faspro (daratumumab) targets specific proteins on cancer cells to help the immune system fight the cancer. Lenalidomide boosts the immune system and blocks cancer cell growth. Dexamethasone reduces inflammation and enhances treatment effectiveness.

Study on Iberdomide, Cyclophosphamide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

This trial tests a combination of iberdomide, cyclophosphamide, and dexamethasone, all taken orally, to evaluate effectiveness in managing relapsed or refractory disease.

Inclusion criteria: Patients must be at least 18 years old with WHO performance status of 0, 1, or 2 and life expectancy of at least 3 months. Female participants of childbearing potential must have negative pregnancy tests and agree to ongoing testing and birth control. Males must agree to use contraception and not donate sperm. All participants must agree not to donate blood during and after the study. Patients must have confirmed multiple myeloma with measurable disease, have received 2-4 prior treatments (pomalidomide allowed), and have developed lenalidomide-refractory disease.

Exclusion criteria: The study excludes patients without relapsed or refractory multiple myeloma, those outside the age range, patients not in specified clinical trial groups, those unwilling to follow procedures, and vulnerable populations unless specific conditions are met.

Trial focus: The study evaluates how long patients can live without disease progression while taking the combination of iberdomide, cyclophosphamide, and dexamethasone. It monitors participants’ health and response, including side effects, overall response rates, and survival.

Investigational drugs: Iberdomide is an experimental immunomodulatory drug affecting the immune system and targeting cancer cells. Cyclophosphamide is chemotherapy that damages cancer cell DNA to prevent growth. Dexamethasone is a steroid that reduces inflammation and enhances other cancer treatments.

Study on Melflufen and Dexamethasone for Elderly Patients with Relapsed Multiple Myeloma

This trial focuses specifically on elderly patients aged 70-85 who have experienced a second or subsequent relapse of their multiple myeloma.

Inclusion criteria: Patients must have relapsed multiple myeloma that has progressed after 2 or more previous treatments. They need adequate liver function with total bilirubin no more than 1.5 times upper normal limit and specific liver enzyme levels. Estimated creatinine clearance must be at least 30 mL/min, and adequate bone marrow function is required with specific blood cell counts. Patients must be 70-85 years old with ECOG performance status of 2 or less, life expectancy of at least 3 months, and have been previously treated with anti-CD38 antibodies, immunomodulatory drugs, and proteasome inhibitors. They need specific M-protein levels and left ventricular ejection fraction of at least 40%.

Exclusion criteria: The trial excludes patients who haven’t experienced relapse, those not in their second or later relapse, non-elderly patients, and vulnerable populations.

Trial focus: The study evaluates the effectiveness of melflufen combined with dexamethasone in elderly patients with multiple relapses. It will monitor response duration, progression-free survival, time to response, and overall survival, with conclusion expected by August 2027.

Investigational drugs: Melflufen is designed to deliver chemotherapy directly to cancer cells for more effective destruction. Dexamethasone is a steroid used to reduce inflammation, suppress the immune system, and enhance other cancer treatment effectiveness.

Study Comparing Teclistamab with Daratumumab, Pomalidomide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

This study compares different treatment combinations, with participants assigned to receive either teclistamab and daratumumab, or daratumumab with pomalidomide and dexamethasone, or daratumumab with bortezomib and dexamethasone.

Inclusion criteria: Patients must have confirmed multiple myeloma diagnosis with measurable disease showing specific protein levels. They must have received 1 to 3 previous treatments, including a proteasome inhibitor and lenalidomide. If only one previous treatment, they must not have responded well to lenalidomide. The disease must show signs of progression, and patients need a performance status score of 0, 1, or 2 with laboratory test results within specified ranges.

Exclusion criteria: The study excludes patients with different cancer types, those outside the age range, patients unable to provide informed consent, pregnant or breastfeeding women, those with interfering health conditions, and recent participants in other clinical trials.

Trial focus: The study evaluates which treatment combination is most effective for managing relapsed or refractory multiple myeloma. Participants are randomly assigned to treatment groups and monitored regularly to gather data on effectiveness and safety.

Investigational drugs: Teclistamab is under investigation for potential multiple myeloma treatment. Daratumumab SC targets proteins on cancer cells to help immune system destruction. Pomalidomide helps the immune system fight cancer. Dexamethasone reduces inflammation and is used with other cancer treatments. Bortezomib interferes with cancer cell growth.

Study Comparing Teclistamab with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma After 1-3 Prior Treatments

This trial compares teclistamab alone against combination treatments including pomalidomide, bortezomib, and dexamethasone, or carfilzomib and dexamethasone.

Inclusion criteria: Patients must have documented multiple myeloma with measurable disease showing specific protein levels. They must have received 1 to 3 previous treatments, including anti-CD38 monoclonal antibody and lenalidomide. Evidence of disease progression or lack of response to the last treatment is required. Patients need ECOG performance status of 0 to 2 and must agree to contraception requirements if applicable.

Exclusion criteria: The study excludes patients with different cancer types, those outside the age range, patients in different clinical trial groups, and vulnerable populations.

Trial focus: The study determines which treatment is more effective for patients with relapsed or refractory multiple myeloma. Participants are randomly assigned to receive either teclistamab or one of the combination treatments, with regular monitoring to track disease progression and overall survival.

Investigational drugs: Teclistamab is being studied for effectiveness against multiple myeloma on its own. Pomalidomide helps the immune system attack cancer cells. Bortezomib interferes with cancer cell growth. Dexamethasone reduces inflammation and improves cancer treatment effectiveness. Carfilzomib blocks certain proteins in cancer cells to cause their death.

Summary

The 15 ongoing clinical trials for plasma cell myeloma refractory span across multiple European countries, with notable concentrations in Belgium, Germany, Italy, and Spain. Several countries including the Netherlands, France, and Greece are also hosting multiple trials. A few trials are being conducted in single countries, such as the melflufen study in Italy and the iberdomide study in the Netherlands.

The trials demonstrate a diverse approach to treatment, ranging from innovative cell therapies like CAR T-cell treatments to various combinations of established medications. Several studies focus on newer bispecific antibodies such as teclistamab and elranatamab, which appear in multiple trials. Common drug combinations being tested include variations of pomalidomide, bortezomib, and dexamethasone, reflecting the current standard approaches to managing this challenging condition.

Many trials specifically target patients who have received limited prior treatments (typically 1-3 lines), while others focus on heavily pre-treated patients who have exhausted multiple treatment options. Some studies address specific patient populations, such as elderly patients aged 70-85 years. The trials generally assess progression-free survival as a primary measure of effectiveness, alongside safety profiles and quality of life impacts.

Ongoing Clinical Trials on Plasma cell myeloma refractory

  • Study of isatuximab, evorpacept and dexamethasone combination therapy for patients with relapsed or refractory multiple myeloma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Norway Portugal

  • Study of isatuximab, pomalidomide and dexamethasone combination for patients with relapsed or refractory multiple myeloma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Norway Portugal

  • Study of isatuximab, belumosudil and dexamethasone combination treatment for patients with relapsed or refractory multiple myeloma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Norway Portugal

  • A Phase 2 Study of JNJ-79635322 in Patients with Relapsed or Refractory Multiple Myeloma

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland

  • AZD0120 versus standard regimens in patients with relapsed or refractory multiple myeloma

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Norway Poland Spain

  • Study of belantamab mafodotin with drug combination in adults aged 18 years and older with relapsed or refractory multiple myeloma

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece The Netherlands Spain

  • Study on the Safety and Effectiveness of Mezigdomide and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Spain

  • Study on the Effectiveness and Safety of Idecabtagene Vicleucel for Patients with Relapsed or Refractory Multiple Myeloma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study Comparing Ciltacabtagene Autoleucel with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed and Lenalidomide-Refractory Multiple Myeloma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Greece Italy +4

  • Study Comparing bb2121 with Standard Treatments for Patients with Relapsed and Refractory Multiple Myeloma

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Norway +1

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