Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
This study is looking into a new medicine called linvoseltamab for adults living with multiple myeloma, a type of blood cancer, especially when previous treatments haven't worked or stopped working. The main goal is to figure out the safest and best dose of linvoseltamab to give. Researchers will also be carefully watching for any side effects people might experience. Another important aim is to see if linvoseltamab can effectively treat the cancer and how it works within the body. By understanding how this new medicine behaves, we hope to find new ways to help patients whose multiple myeloma has been difficult to treat.
At a glance
What is this study about?
This study is focused on a new medicine called linvoseltamab, which is being tested for adults diagnosed with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. Sometimes, despite receiving standard treatments, the cancer can return or stop responding effectively. When this happens, it's called 'relapsed' or 'refractory' multiple myeloma.
The main reasons for doing this study are to check if linvoseltamab is safe to use and to find the best amount (dose) of the drug to give. Researchers will also be looking closely at any unwanted effects, known as side effects, that people might have. They want to understand how the medicine travels through the body, how much stays in the blood, and importantly, if it can help to control or treat the cancer. This research is vital because it could offer a new option for people whose multiple myeloma has been particularly challenging to treat with existing medicines.
The study is divided into different parts. Initially, smaller groups of patients receive increasing doses of linvoseltamab to find a safe and effective dose (Phase 1). Once a good dose is found, more patients will be studied to further confirm its safety and effectiveness (Phase 2). All the information gathered will help doctors learn more about linvoseltamab and its potential to help people with multiple myeloma.
Key takeaways
- This study is testing a new medicine, linvoseltamab, for hard-to-treat multiple myeloma.
- It aims to find the safest and most effective dose of the medicine.
- Researchers will also track side effects and how the medicine works in the body.
- It's for adults whose myeloma hasn't responded to several standard treatments.
- Participation involves clinic visits, blood tests, and medical check-ups.
- You can stop participating at any time without affecting your normal care.
Who may be eligible?
To join this study, adults must have been diagnosed with active multiple myeloma that hasn't responded well to previous treatments, including certain strong medicines like a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. This means your cancer has either come back after treatment or stopped responding.
Also, your general health and ability to perform daily activities must be good, assessed by a scoring system called ECOG. The doctors need to be able to measure how your cancer is responding to treatment using standard criteria. If your multiple myeloma is still growing or has returned after previous treatments with these specific types of medications, you might be suitable for this study.
There are slightly different requirements for various stages of the study, but generally, you need to have tried and not fully responded to at least three different types of myeloma treatments, or your cancer must be 'triple-refractory', meaning it hasn't responded to a proteasome inhibitor, an IMiD, and an anti-CD38 antibody.
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 with multiple myeloma?
- Has your multiple myeloma come back or not responded to previous treatments?
- Have you tried at least three different types of myeloma medications, including specific ones like a proteasome inhibitor, an IMiD, and an anti-CD38 antibody?
- Is your general health good enough for you to manage daily activities?
- Have doctors confirmed your myeloma can be measured to see how it's responding to treatment?
What does participation involve?
If you join this study, you will receive the new medicine called linvoseltamab. Initially, the study focuses on finding the safest and most effective dose. This means some participants might start on a lower dose, which could be gradually increased. You would have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medication. These visits are important for monitoring how you are responding to the treatment and to keep an eye on any side effects.
The research team will carry out various tests, including blood samples, to understand how the medicine works in your body and how much of it is present. They will also assess your myeloma to see if the treatment is working. The total length of your participation, including how often you attend the clinic and for how long, will depend on the phase of the study you are in and how you respond to the treatment. There will be follow-up appointments even after you stop receiving the study medicine to continue monitoring your health.
Potential risks and benefits
Locations (40)
- Sylvester Comprehensive Cancer CenterVerified postcodeMiami, United States· Active not recruiting
- Moffitt Cancer Center - McKinley DriveVerified postcodeTampa, United States· Recruiting
- Emory University HospitalVerified postcodeAtlanta, United States· Recruiting
- Indiana University_Michigan StreetVerified postcodeIndianapolis, United States· Active not recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Recruiting
- C. S. Mott_University of MichiganVerified postcodeAnn Arbor, United States· Active not recruiting
- Barbara Ann Karmanos Cancer CenterVerified postcodeDetroit, United States· Active not recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Active not recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
- Columbia University Medical CenterVerified postcodeNew York, United States· Active not recruiting
- Ohio State University James Cancer HospitalVerified postcodeColumbus, United States· Recruiting
- Oregon Health and Science University (OHSU) Marquam Hill CampusVerified postcodePortland, United States· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell that helps fight infection. These cells build up in the bone marrow and can cause problems.
What does 'relapsed or refractory' mean?
It means your multiple myeloma has either come back after it was treated (relapsed) or it hasn't responded to previous treatments (refractory).
What is linvoseltamab?
Linvoseltamab is a new medicine being tested in this study to see if it can help treat multiple myeloma.
What is the 'best dose' they're looking for?
The 'best dose' is the amount of medicine that is most likely to help treat the cancer while causing the fewest and mildest side effects.
Can I stop taking part in the study if I want to?
Yes, you can choose to leave the study at any time, and this will not affect your regular medical care.
How to find out more
Clinical Trial 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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