Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
This study is looking into a new treatment called HDP-101 for adults with multiple myeloma, a type of blood cancer. This is for people whose cancer has either returned after treatment or didn't respond to their previous therapies. The main goals are to check if HDP-101 is safe to use and to find the best dose. Researchers also want to see how the medicine acts in the body and if it shows any signs of helping to treat the cancer. The study will happen in two stages: first, finding the right dose, and then, expanding to more people to gather more information on safety and potential benefits. This research could help bring new options to patients who have limited choices left.
במבט חטוף
על מה המחקר הזה?
This research study is about a new medicine called HDP-101. It's being tested for people who have multiple myeloma, which is a cancer of certain white blood cells called plasma cells. For this study, participants will have multiple myeloma that has either come back after past treatments or hasn't responded well to those treatments. This means that standard treatments haven't been successful for them.
The main purpose of the study is to find out if HDP-101 is safe for people to take and what the best dose might be. The researchers will also be watching to see how the medicine works in the body and if it has any effect on the cancer. Think of it like taking baby steps – first, making sure it's safe at different doses, and then looking more closely at if it helps.
This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The hope is that HDP-101 could eventually become another treatment option for people with multiple myeloma, especially for those whose cancer has been difficult to treat.
נקודות עיקריות
- This study tests a new medicine (HDP-101) for multiple myeloma that has come back or not responded to other treatments.
- The main goals are to check the medicine's safety and find the best dose.
- You must have already tried certain standard multiple myeloma treatments.
- Regular hospital visits and tests will monitor your health and cancer.
- You can stop participating at any time, for any reason.
- This is an early-stage study, so results are not guaranteed, but it could offer a new treatment option.
מי עשוי להיות זכאי?
To join this study, you need to be an adult, aged 18 or older, and have a confirmed diagnosis of active multiple myeloma. Your doctors must have assessed that you are likely to live for more than 12 weeks, and your general health and fitness, as measured by a specific scale, should be good enough to take part.
You must have already received several standard treatments for multiple myeloma, including certain types of medicines (like immunomodulatory drugs, proteasome inhibitors, and anti-CD38 treatments). Importantly, your cancer must either have stopped responding to these treatments or they couldn't be tolerated. Also, your cancer needs to be 'measurable,' meaning your doctors can track its presence and size.
There are also reasons why you might not be able to join. For instance, if you have certain other serious health conditions, or if the cancer has spread to your brain or spinal cord. If you've recently had a stem cell transplant or radiation therapy, or if you have certain active infections like HIV or hepatitis, you wouldn't be able to participate. Also, if you've already had a treatment that specifically targets something called BCMA (for those entering the second part of the study), you wouldn't be eligible.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- אני בן 18 או יותר.
- I have been diagnosed with active multiple myeloma.
- My multiple myeloma has come back or not responded to previous treatments.
- I have already received specific prior treatments for multiple myeloma (e.g., immunomodulatory drugs, proteasome inhibitors, anti-CD38).
- My cancer is measurable by doctors' tests.
- I do not have other serious active medical conditions or infections like HIV or hepatitis.
מה כרוך בהשתתפות?
If you join this study, you would receive the new study medicine, HDP-101. The study starts with a phase to find the safest and most effective dose, where a small group of people will receive carefully chosen doses. Once the best dose is found, more people will join to get that specific dose and help gather more information.
Throughout your time in the study, you would have regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks. This includes blood tests to see how the medicine is working and how your body is handling it, as well as scans or other tests to monitor your multiple myeloma. The study team will explain exactly how often these visits will be.
The exact duration of your participation would depend on how your body responds to the treatment and the study plan. You would have regular check-ups to monitor your health and the progress of your cancer. All visits, tests, and the study medicine, HDP-101, would be provided as part of the research – you wouldn't have to pay for them.
סיכונים ותועלות פוטנציאליים
Locations (16)
- Winship Cancer Institute of Emory Universityמיקוד מאומתאטלנטה, ארצות הברית· גיוס
- Mount Sinai, The Tisch Cancer Instututeמיקוד מאומתניו יורק, ארצות הברית· גיוס
- MD Anderson Cancer Centerמיקוד מאומתיוסטון, ארצות הברית· גיוס
- Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologieמיקוד מאומתברלין, גרמניה· עדיין לא מגייסים
- Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin IIIמיקוד מאומתכימניץ, גרמניה· גיוס
- Universitätsklinikum Kölnמיקוד מאומתקלן, גרמניה· גיוס
- Asklepios Klinik Altona, Haematologie und internistische Onkologieמיקוד מאומתהמבורג, גרמניה· גיוס
- Universitätsklinikum Heidelbergמיקוד מאומתהיידלברג, גרמניה· גיוס
- Universitätsklinikum Schleswig-Holsteinמיקוד מאומתKiel, Germany· גיוס
- UKSH Campus Lübeck Klinik für Hämatologie und Onkologieמיקוד מאומתליבק, גרמניה· גיוס
- Universitätsklinikum Mainzמיקוד מאומתמיינץ, גרמניה· נמשך
- Semmelweis University, Belgyogyaszati es Onkologiai Klinikaמיקוד מאומתבודפשט, הונגריה· גיוס
שאלות נפוצות
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the bone marrow, affecting white blood cells called plasma cells.
מה המשמעות של 'חזרה/עמידות'?
It means the cancer has either come back after previous treatments or didn't respond to them, making it harder to treat.
Is HDP-101 a chemotherapy drug?
HDP-101 is a new, investigational medicine. The study will help us understand more about how it works.
What is the purpose of a Phase 1/2 study?
Phase 1 studies primarily check if a new medicine is safe and help find the right dose. Phase 2 studies then look for early signs of whether the medicine works.
האם אדע אם אני מקבל את התרופה למחקר?
Yes, everyone in this study will receive the active study medicine, HDP-101, there is no placebo group.
כיצד לגלות עוד
András Strassz, MD
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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