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Study on Alnuctamab and Drug Combination for Patients with Relapsed or Refractory Multiple Myeloma

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Multiple Myeloma, which affects the blood and bone marrow. The study is specifically for patients whose cancer has returned or has not responded to previous treatments, known as Relapsed or Refractory Multiple Myeloma. The main treatment being tested in this study is a medication called Alnuctamab, which is being compared to standard treatments that are currently used for this condition. The goal of the study is to determine if Alnuctamab can help patients live longer without their cancer worsening.

Participants in the study will receive either Alnuctamab or one of the standard treatments. The study will monitor how long it takes for the cancer to progress or for the patient to pass away, which is referred to as "progression-free survival." Researchers will also look at the overall survival of participants, which means how long they live in total. Additionally, the study will assess how well the cancer responds to the treatment, the duration of the response, and the time it takes for patients to start a new treatment. The safety of Alnuctamab and any side effects experienced by participants will also be closely monitored.

The study aims to provide valuable information on whether Alnuctamab is a safe and effective treatment option for people with Multiple Myeloma. The trial is expected to continue until 2031, with recruitment of participants starting in 2024. This research could potentially lead to new treatment options for patients with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose, procedures, and potential risks and benefits.

    The participant will sign an informed consent form, confirming their understanding and willingness to participate.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility, which includes a documented diagnosis of relapsed or refractory multiple myeloma.

    The assessment will also verify that the participant has received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody.

  3. Step 3

    Randomization

    Participants will be randomly assigned to receive either the experimental treatment with alnuctamab or a standard care regimen.

  4. Step 4

    Treatment phase

    Participants receiving alnuctamab will be administered the medication as a solution for injection.

    Participants in the standard care group may receive medications such as Empliciti (elotuzumab) as a solution for infusion, DARZALEX (daratumumab) as a solution for injection, Imnovid (pomalidomide) in capsule form, Kyprolis (carfilzomib) as a solution for infusion, and DEXAMETHASONE in capsule form.

    The specific dosage and frequency will depend on the assigned treatment regimen.

  5. Step 5

    Monitoring and follow-up

    Participants will be regularly monitored to assess the treatment's effectiveness and any side effects.

    The main focus will be on progression-free survival, which is the time from starting treatment until the cancer worsens or the participant passes away.

    Secondary assessments will include overall survival, cancer response to treatment, and quality of life.

  6. Step 6

    End of study

    The study is estimated to conclude by January 1, 2031.

    Participants will have a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

9 criteria

  • Participant must be at least 18 years old or the legal age of consent in the area where the study is happening.
  • Participant must have a confirmed diagnosis of **Multiple Myeloma (MM)**, a type of blood cancer.
  • Participant must have received at least 1 but not more than 3 previous treatments for MM. One treatment can include a series of planned therapies, such as initial treatment, possibly followed by a stem cell transplant, and additional therapies to maintain the response.
  • Participant must have been treated before with **lenalidomide**, a medication used to treat MM, and an **anti-CD38 monoclonal antibody**, a type of drug that targets specific proteins on cancer cells, for at least 2 cycles in a row.
  • Participant must have shown at least a minimal improvement in response to at least one previous MM treatment.
  • Participant must have experienced disease progression, meaning the cancer got worse, during or after their last MM treatment, or did not respond to the treatment.
  • Participant must have measurable disease, which means the cancer can be measured by tests. This includes having at least one of the following:
    • **Myeloma (M)-protein** levels of at least 0.5 grams per deciliter in the blood.
    • At least 200 milligrams of protein in a 24-hour urine collection.
    • **Serum free light chain** levels greater than 100 milligrams per liter, with an abnormal ratio of kappa to lambda light chains, in participants without detectable M-protein in blood or urine.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with relapsed or refractory multiple myeloma. This means the cancer has returned after treatment or has not responded to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific clinical trial group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population. This refers to groups of people who might need special protection or care.
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Investigated drugs

Alnuctamab is a medication being studied to see if it can help people with relapsed or refractory multiple myeloma live longer without their cancer getting worse. It is being compared to standard treatments to evaluate its effectiveness and safety.

What is already known about the treatment

Alnuctamab – Alnuctamab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of blood cancer. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. Alnuctamab is classified as a monoclonal antibody, a type of drug designed to bind to specific targets in the body.

Investigated diseases

Relapsed and/or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has returned after treatment (relapsed) or does not respond to treatment (refractory). It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to high levels of calcium in the blood, anemia, and kidney problems. As it advances, it becomes more challenging to manage and requires different treatment strategies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509472-42-00Protocol codeCA058-1019Estimated enrolment466 patientsSponsorCelgene International II S.a.r.l.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).