A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
This study is looking into a new medication called linvoseltamab for adults who have recently been diagnosed with multiple myeloma and have not yet received any treatment. The main goals are to find out if the drug is safe, how well people tolerate it (meaning, how their body reacts to it), and if it can help shrink the cancer. We're testing different doses to find the most effective and safe amount to give. This research includes people who might be able to have a stem cell transplant and those who can't, to see if linvoseltamab could be a helpful treatment option for many different patients with newly diagnosed multiple myeloma.
At a glance
What is this study about?
This study focuses on a new experimental drug called linvoseltamab. We are researching this drug to see if it could become a new treatment option for multiple myeloma, a type of cancer that affects plasma cells in your bone marrow. This particular study is for people who have recently been diagnosed with multiple myeloma and haven't started any treatment yet.
The main idea behind this study is to carefully look at how safe the drug is and how well people's bodies cope with it. We also want to understand if linvoseltamab can effectively shrink the myeloma. This is a very early stage of testing, so we're starting with small groups of people to figure out the best dose and schedule for giving the drug. Later on, more people will receive the drug to get a clearer picture of its effects.
By taking part, you would be helping researchers learn important information, such as what side effects might occur, what the best dose of linvoseltamab is, and how many people's disease improves while taking it. We will also look at how much of the drug stays in your blood and if your body creates a resistance to it. This information is crucial for deciding if linvoseltamab has a future role in treating multiple myeloma.
Key takeaways
- This study is for adults with recently diagnosed (untreated) multiple myeloma.
- It's testing a new drug called linvoseltamab to check its safety and how well it fights the cancer.
- The study includes finding the best dose and schedule for the drug.
- Participation involves regular hospital visits for drug administration and health checks.
- There are potential benefits and risks, which will be fully explained by the study team.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is for adults aged 18 and over who have been recently diagnosed with multiple myeloma and have not yet had any treatment for it, except for certain quick treatments like emergency radiation or a short course of steroids if absolutely necessary.
You might be able to join if you are generally well, can manage your daily activities, and have good organ function (meaning your liver, kidneys, heart, and bone marrow are working properly). There are also specific checks to make sure your type of multiple myeloma can be measured and tracked during the study.
However, you wouldn't be able to join if you are already taking other experimental cancer drugs, have multiple myeloma that affects your brain or spinal cord, have certain other neurological conditions, or have a type of multiple myeloma that needs very urgent treatment that can't wait for this study. Also, if you have other specific blood disorders or rare conditions linked to multiple myeloma, you may not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult (18 years or older)?
- Have you recently been diagnosed with multiple myeloma?
- Have you NOT received any treatment for multiple myeloma yet (besides emergency or very short-term care)?
- Are you generally feeling well and able to manage most everyday activities?
- Do you have good overall health, including your heart, kidneys, and liver working well?
- For those under 70, are your organs healthy enough for a potential transplant, if recommended by your doctor?
What does participation involve?
If you join this study, you will receive the experimental drug, linvoseltamab. Initially, the study will involve carefully increasing the dose for participants to find the safest and most effective amount. This will involve regular visits to the hospital for drug administration and checks.
Throughout the study, you'll have frequent appointments, which will include blood tests, physical exams, and other assessments to monitor your health, how your body is reacting to the drug, and how the multiple myeloma is responding. The number of visits and the assessments will be more frequent at the beginning and might become less often if you continue with the treatment and are doing well.
The total length of time you'll be on the study drug and taking part in follow-up appointments will vary for each person, depending on how they respond to the treatment and their overall health.
Potential risks and benefits
Locations (32)
- University of California Los Angeles (UCLA)Verified postcodeLos Angeles, United States· Recruiting
- UC Irvine HealthVerified postcodeOrange, United States· Recruiting
- Colorado Blood Cancer Institute/SCRIVerified postcodeDenver, United States· Recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Recruiting
- Perlmutter Cancer Center at NYU Langone Hospital - Long IslandVerified postcodeMineola, United States· Recruiting
- Perlmutter Cancer CenterVerified postcodeNew York, United States· Recruiting
- Columbia University _ New York PresbyterianVerified postcodeNew York, United States· Recruiting
- Stony Brook University HospitalVerified postcodeStony Brook, United States· Recruiting
- Levine Cancer InstituteVerified postcodeCharlotte, United States· Recruiting
- Duke University Health System (DUHS)Verified postcodeDurham, United States· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in your plasma cells, which are a type of white blood cell found in your bone marrow. These abnormal cells can build up and cause problems in your bones, kidneys, and immune system.
What is 'newly diagnosed' multiple myeloma?
Newly diagnosed means you have recently found out you have multiple myeloma and have not yet received any treatment for it, beyond possibly some very brief emergency care.
What does 'experimental drug' mean?
An experimental drug means it's a new medication that is still being tested in clinical trials to see if it's safe and effective, before it can be approved for general use.
Will I get the actual study drug, or a dummy drug?
In this particular study, all participants will receive the study drug, linvoseltamab. There isn't a dummy drug (placebo) part to this trial.
Can I leave the study at any time?
Yes, you can choose to leave the study at any point, for any reason, and your decision will not affect your usual medical care.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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