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

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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 blood cancer called Multiple Myeloma, specifically in patients whose disease has returned or has not responded to previous treatments. The study will test a combination of two treatments: Alnuctamab and Mezigdomide. Alnuctamab is given as an injection under the skin, while Mezigdomide is taken as a capsule by mouth. The purpose of the study is to find out how safe these treatments are when used together and to determine the best dose and schedule for taking Mezigdomide with Alnuctamab.

Participants in the study will receive either the combination of Alnuctamab and Mezigdomide or Alnuctamab alone. The study will monitor the safety of these treatments and how well they work in controlling the cancer. The study will also compare the effects of the combination treatment to Alnuctamab alone. Throughout the study, participants will have regular check-ups to assess their response to the treatment and any side effects they may experience.

The study will continue until the researchers have enough information to understand the safety and effectiveness of the treatments. Participants will be followed closely, and their health will be monitored even after they stop receiving the study treatments. This trial aims to provide new insights into treating Relapsed and Refractory Multiple Myeloma and potentially improve outcomes for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing your medical history and ensuring you meet the criteria for participation, such as having a history of relapsed and/or refractory multiple myeloma and having received the required number of prior treatments.
Step 2
Treatment initiation
The treatment phase begins with the administration of alnuctamab and mezigdomide. Alnuctamab is given as a solution for injection under the skin (subcutaneous).
You will also take mezigdomide orally in the form of capsules. The dosage of mezigdomide may vary, including 0.2 mg, 0.3 mg, 0.4 mg, or 0.6 mg, depending on the phase of the trial and your specific treatment plan.
Step 3
Ongoing treatment and monitoring
Throughout the trial, you will continue to receive alnuctamab and mezigdomide as per the schedule determined by the study team. Dexamethasone, another oral medication, may also be part of your treatment regimen.
Regular monitoring will be conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and evaluating your response to the therapy.
Step 4
Evaluation of response
Your response to the treatment will be evaluated at the start of each cycle, beginning with Cycle 2 Day 1. This involves measuring the extent to which the multiple myeloma responds to the treatment.
Additional assessments will be conducted every 8 weeks to monitor progression, unless you withdraw consent, the disease progresses, or new treatments are initiated.
Step 5
End of treatment
The treatment phase will conclude based on the study's schedule or if you decide to withdraw from the trial. After the last dose of alnuctamab or mezigdomide, follow-up assessments will continue for a specified period to monitor your health and any long-term effects of the treatment.

Who can join the trial?

6 criteria

Must be at least 18 years old.
Must have a history of Relapsed and/or Refractory Multiple Myeloma (RRMM), which means the disease has returned or is not responding to treatment.
Must have been treated with 3 or more previous treatments for multiple myeloma if participating in Part A, or 1 to 3 previous treatments if participating in Parts B and C.
Must have measurable multiple myeloma, which means the disease can be measured by tests done in a central laboratory.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which indicates that the person is fully active or has some symptoms but does not require bed rest.
Must agree to follow contraception requirements to prevent pregnancy during the study.

Who cannot join the trial?

8 criteria

Patients who have not been diagnosed with Relapsed and/or Refractory Multiple Myeloma cannot participate. This is a type of blood cancer that has returned after treatment or is not responding to treatment.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults only.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or adverse reactions to the study medications cannot participate.
Patients who are unable to provide informed consent cannot participate. This means they must understand the study and agree to take part.

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Verified sites

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Aarhus University Hospital
Aarhus, Denmark
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Odense University Hospital
Odense, Denmark

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Investigated drugs

Alnuctamab
is a type of treatment that helps the body's immune system fight cancer cells. It works by targeting specific proteins on the surface of cancer cells, which helps the immune system recognize and destroy these harmful cells. In this trial, alnuctamab is being tested to see how safe it is and how well it works when used alone or in combination with another medication.
Mezigdomide
is a medication that is being studied for its potential to treat multiple myeloma, a type of blood cancer. It is designed to interfere with the growth and survival of cancer cells. In this trial, researchers are looking at how mezigdomide works when given together with alnuctamab, to see if the combination is more effective than using alnuctamab by itself. The study also aims to find the best dose and schedule for taking mezigdomide with alnuctamab.

What is already known about the treatment

Alnuctamab
Alnuctamab is administered through an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its use in treating relapsed and/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 interact with specific targets in the body.
Mezigdomide
Mezigdomide is taken orally, usually in the form of a pill. It is under investigation in clinical trials for its potential to treat relapsed and/or refractory multiple myeloma. The drug functions by modulating the immune system and affecting the growth of cancer cells, aiming to slow down or stop their proliferation. Mezigdomide is classified as an immunomodulatory agent, which means it helps regulate the immune system's response to cancer.

Investigated diseases

Relapsed and Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type 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). The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Over time, the accumulation of these cells can cause bone pain, fractures, and anemia. The disease can also lead to high levels of calcium in the blood, which can cause further complications. As the condition advances, it may become increasingly difficult to manage with standard therapies.