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A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

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What is this trial about?

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

This study involves people with Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. Plasma cells are a kind of white blood cell that normally helps fight infections by making antibodies. In this disease, abnormal plasma cells multiply too much and crowd out healthy blood cells, which can lead to various health problems. The study will test a medicine called etentamig, which is also known by its code name ABBV-383. This medicine will be given either alone or together with other medicines that are already used to treat this condition. These other medicines include daratumumab, lenalidomide, dexamethasone, and carfilzomib. The treatment combinations being tested depend on whether someone has newly diagnosed disease or disease that has come back or did not respond to previous treatment.

The purpose of this study is to find out how safe these treatment combinations are and what side effects they might cause, and also to determine the best doses of etentamig when given alone or with other medicines. The study will also look at how well these treatments work in controlling the disease. Etentamig is given as an infusion, which means it is delivered directly into a vein over a period of time. Some of the other medicines are taken by mouth as capsules or tablets, while others are given as injections under the skin or into a vein.

During the study, participants will receive their assigned treatment combination and will be monitored regularly to check how they respond to the treatment and whether they experience any unwanted effects. The study team will measure things like whether the cancer responds to treatment, how long any response lasts, and how long participants remain without their disease getting worse. Some participants will receive treatment right after their diagnosis, while others will receive it as a maintenance therapy after other treatments, and some will receive it because their disease has returned or did not respond to earlier treatments. The specific treatment plan depends on which part of the study someone joins.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and confirmation
Your diagnosis of multiple myeloma (a type of blood cancer affecting plasma cells in the bone marrow) will be confirmed according to international diagnostic criteria.
Your overall physical condition will be assessed using a standard scale that ranges from 0 to 5, where lower numbers indicate better ability to perform daily activities. Your score must be 1 or lower to participate.
Laboratory tests will be performed to check that your blood and organ function values meet the specific requirements for the substudy you will be assigned to.
Step 2
Assignment to treatment group
You will be assigned to one of four substudies based on your disease status and treatment history.
Substudy 1 is for patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant. You will receive etentamig given through an intravenous infusion (into a vein), combined with daratumumab given by injection and lenalidomide taken by mouth.
Substudy 2 is for patients with newly diagnosed multiple myeloma who are eligible for stem cell transplant. You will receive etentamig alone as maintenance treatment, given through an intravenous infusion.
Substudy 3 is for patients whose multiple myeloma has returned or did not respond to previous treatment. You will receive etentamig given through an intravenous infusion, combined with carfilzomib given intravenously and dexamethasone taken by mouth.
Substudy 4 is for patients with newly diagnosed multiple myeloma who are eligible for stem cell transplant. You will receive etentamig given through an intravenous infusion combined with lenalidomide taken by mouth as maintenance treatment.
Step 3
Treatment phase
The study will evaluate the safety and effectiveness of etentamig, either alone or in combination with other medications.
Etentamig will be administered as an intravenous infusion, meaning the medication will be delivered directly into your vein over a period of time.
If you are assigned to a combination treatment, additional medications will be given according to your substudy protocol.
Daratumumab (if prescribed) will be given as a solution for injection.
Lenalidomide (if prescribed) will be taken by mouth as capsules or tablets.
Dexamethasone (if prescribed) will be taken by mouth or given as a subcutaneous injection (under the skin).
Carfilzomib (if prescribed) will be given through an intravenous infusion.
The specific doses, frequency, and duration of each medication will be determined based on the substudy protocol and your individual response to treatment.
During the initial treatment period, the study team will carefully monitor you for any dose-limiting toxicities, which are serious side effects that may require dose adjustments.
Step 4
Ongoing monitoring and assessments
Throughout the study, you will undergo regular assessments to monitor your disease status and any side effects.
Blood tests and other laboratory evaluations will be performed at scheduled intervals.
Your response to treatment will be measured using standard criteria, including whether your cancer has completely responded, partially responded, remained stable, or progressed.
Minimal residual disease testing may be performed to detect very small amounts of cancer cells that remain after treatment.
Any adverse events (unwanted or harmful effects) will be documented and assessed for severity and relationship to the study treatment.
Step 5
Response evaluation
The study will measure several outcomes to determine how well the treatment is working.
Overall response rate refers to the percentage of patients whose cancer shrinks or disappears.
Complete response rate measures the percentage of patients whose cancer becomes undetectable by standard tests.
Duration of response tracks how long your cancer remains controlled after responding to treatment.
Progression-free survival measures the length of time during and after treatment that your cancer does not grow or spread.
Time-to-progression tracks how long it takes before your cancer begins to grow or spread again.
Step 6
Continuation of treatment
If you are tolerating the treatment well and your cancer is responding, you may continue receiving the study medication according to your substudy protocol.
The recommended doses for each treatment combination will be determined based on safety and effectiveness data collected during the study.
Treatment may continue for an extended period as part of maintenance therapy, particularly in substudies 2 and 4.
Step 7
Study completion
The study is expected to continue until February 2036, though your individual participation duration will depend on your substudy assignment and treatment response.
You may discontinue treatment earlier if your cancer progresses, if you experience unacceptable side effects, or for other medical reasons.
Final assessments will be performed to evaluate your overall response to treatment and document any long-term effects.

Who can join the trial?

5 criteria

You must have a performance status score of 1 or less according to the ECOG scale, which means you are able to carry out light work or normal activities with little or no symptoms
You must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer affecting plasma cells in the bone marrow, and your disease may be newly diagnosed or have come back after treatment or not responded to previous treatment, depending on which part of the study you join
Your blood test results must meet specific requirements as described in the study plan during the screening period before you receive the first dose of the study treatment
You can be male or female
You must be an adult to participate in this study

Who cannot join the trial?

4 criteria

The specific exclusion criteria (reasons why you cannot participate) have not been provided in the available study information
Generally, clinical trials have rules about who cannot join to make sure the study is safe and the results are reliable
Common reasons people may not be able to join cancer studies include having other serious medical conditions, being pregnant or breastfeeding, having certain blood test results outside normal ranges, or taking medications that might interfere with the study treatment
Your doctor will review all requirements with you to determine if you can safely participate in this study

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Etentamig is a medication being tested in people with multiple myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. This medicine is being studied both on its own and in combination with other treatments to see how well it works and how safe it is for patients with this condition.

What is already known about the treatment

Etentamig – Etentamig is an investigational medication currently being studied in clinical trials for the treatment of multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. This drug is being evaluated both as a single treatment and in combination with other anti-cancer agents to determine its safety, tolerability, and effectiveness in patients with this condition. The exact mechanism of how etentamig works at the molecular level has not been fully detailed in available trial information, but it is being developed as a targeted therapy for multiple myeloma. As an experimental treatment still in Phase 1/2 clinical trials, etentamig is not yet approved for general medical use and is only available to patients participating in research studies.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that develops in the bone marrow, where plasma cells grow abnormally and uncontrollably. Plasma cells are a type of white blood cell that normally produces antibodies to help fight infections. In multiple myeloma, these cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. The abnormal plasma cells produce abnormal proteins that can cause damage to various organs, particularly the bones and kidneys. As the disease progresses, the buildup of cancerous cells in the bone marrow interferes with the production of normal blood cells, leading to anemia, weakened immune system, and bleeding problems. The condition can also cause bone pain, bone fractures, and elevated calcium levels in the blood.