An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
This study, called a Phase 1/2 trial, is looking at a new medicine called GEN3014 (also known as HexaBody®-CD38). It's for adults with certain blood cancers, specifically Multiple Myeloma, Diffuse Large B Cell Lymphoma, and Acute Myeloid Leukemia, that have either returned after treatment or haven't responded to other medicines. The main goals are to find out if GEN3014 is safe, what side effects it might cause, and if it helps to treat these cancers. Researchers will also compare it to an existing medicine, DARZALEX, in some cases. This is an early-stage study, meaning it's one of the first times this medicine is being given to people.
At a glance
What is this study about?
This study is a clinical trial, which is a type of medical research involving people. Its main purpose is to test a new medicine called GEN3014. This medicine is designed to treat certain blood cancers, specifically Multiple Myeloma, Diffuse Large B Cell Lymphoma, and Acute Myeloid Leukemia. These are cancers that affect blood cells and bone marrow. The study is particularly for people whose cancer has either come back after past treatments (relapsed) or hasn't responded to other medicines (refractory).
This trial is made up of two parts, called Phase 1 and Phase 2. Phase 1 trials are usually the first time a new medicine is given to people. The main focus at this stage is to check if the medicine is safe and to find the right dose. Phase 2 trials then look more closely at how well the medicine works, while still monitoring safety. The researchers will be carefully watching for any side effects and how the participants' bodies react to the medicine.
During the study, some participants will receive GEN3014, while others might receive DARZALEX, which is another medicine used for these conditions. By comparing the new medicine to an existing one, doctors can learn more about its potential benefits and risks. The goal is to see if GEN3014 could be a new and effective treatment option for these difficult-to-treat blood cancers.
Key takeaways
- Tests a new medicine (GEN3014) for specific blood cancers.
- For adults whose cancer has returned or didn't respond to previous treatment.
- Aims to check safety and how well the new medicine works.
- Compares GEN3014 to an existing treatment (DARZALEX) in some cases.
- Involves regular clinic visits and close health monitoring.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have one of three types of blood cancer: Multiple Myeloma, Diffuse Large B Cell Lymphoma, or Acute Myeloid Leukemia.
It's important that your cancer has either come back after you've had treatment for it before, or that it hasn't responded to your previous treatments. The study is looking for people in these specific situations.
There might be other health requirements or previous treatment details that determine if you can join. A doctor involved in the study will review your full medical history to see if it’s a good fit for you.
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 18 years old or older?
- Do you have Multiple Myeloma, Diffuse Large B Cell Lymphoma, or Acute Myeloid Leukemia?
- Has your cancer come back after a previous treatment?
- Or has your cancer not responded to previous treatments?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you will receive either the new medicine GEN3014 or a standard medicine named DARZALEX. You will come to the clinic regularly for check-ups. During these visits, doctors will closely monitor your health by taking blood samples, checking your vital signs (like blood pressure and heart rate), and performing heart checks using an electrocardiogram (ECG). They will also ask you about how you are feeling and any side effects you might be experiencing.
Some visits might involve longer stays for observation after you receive the medicine. The total length of your participation can vary depending on how you respond to the treatment and the phase of the study you are in, but it will involve ongoing follow-up visits to track your progress and long-term health. The doctors will explain the exact schedule and duration to you in detail.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedDenmark
- —UnverifiedGreece
- —UnverifiedPoland
Common questions
What kind of cancers is this study for?
This study is for adults with Multiple Myeloma, Diffuse Large B Cell Lymphoma, or Acute Myeloid Leukemia that have come back or not responded to previous treatments.
What is GEN3014?
GEN3014 is a new medicine being tested in this study to see if it can treat these specific blood cancers.
Will I definitely get the new medicine?
Some participants will receive GEN3014, while others might receive DARZALEX, an existing medicine, as part of the study design.
What does 'relapsed or refractory' mean?
It means your cancer has either returned after you've had treatment, or it hasn't responded to the treatments you've received.
How long will I be in the study?
The length of time you'd be in the study will depend on your response to treatment and the specific part of the study you're in. This will be explained in detail.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.