A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
This study is for adults in the UK who have multiple myeloma, a type of blood cancer, that has either returned after previous treatment or isn't getting better with current therapies. It's testing a new drug called Cemsidomide, given together with Dexamethasone, a commonly used steroid. Researchers want to find out how effective this drug combination is at fighting the cancer and to understand its side effects. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments. Participants will receive the treatment, and doctors will carefully monitor their health and how their cancer responds. The goal is to see if this new approach could be a helpful option for people with this specific type of multiple myeloma.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is designed for individuals in the UK who are living with multiple myeloma. Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell found in the bone marrow. When we talk about "relapsed/refractory" multiple myeloma, it means the cancer has either returned after being treated, or it hasn't responded well to previous treatments.
The main purpose of this study is to investigate a new drug called Cemsidomide, which will be given alongside Dexamethasone, a steroid medication often used in cancer treatment. Researchers want to see if this combination can effectively fight the myeloma. They will also be closely watching for any side effects to understand how safe the treatment is and how well people tolerate it.
This is a Phase 2 study, which means it's one of the earlier steps in testing a new treatment. It's about gathering more information on how well the treatment works and its safety profile in a group of people with the condition. The hope is that the findings from this study could potentially lead to new and better treatment options for people with multiple myeloma that is difficult to treat.
النقاط الرئيسية
- This study is for adults with multiple myeloma that has returned or isn't responding to current treatments.
- It's testing a new drug, Cemsidomide, given with Dexamethasone, to see how well it works and if it's safe.
- Participants must have had at least three previous myeloma treatments.
- Your health will be closely monitored by a medical team.
- يمكنك الانسحاب من الدراسة في أي وقت دون التأثير على رعايتك.
من قد يكون مؤهلاً؟
To join this study, you need to be at least 18 years old and have been diagnosed with multiple myeloma that has either come back or isn't responding to other treatments. You also need to have received at least three different types of anti-myeloma treatments before, including specific kinds of drugs like those that target immune cells, proteasome inhibitors, and anti-CD38 antibodies, or newer T-cell therapies, unless these weren't available in your area.
There are also some important health requirements. Your body's organs, like your heart, liver, and kidneys, need to be working well. Any side effects you had from previous cancer treatments must have cleared up or be very mild. For women, it's important not to be pregnant, plan to become pregnant, or breastfeed during the study and for a period after. Men must agree to use contraception during the study and for some time after. Also, you shouldn't have certain other health conditions like specific types of nerve problems, other cancers that are active, or a history of certain heart or blood clot issues.
Crucially, you cannot have had Cemsidomide before, as this is a new treatment being tested. The study will also check that your myeloma hasn't spread to your brain or spinal cord. These rules help make sure the study is safe for everyone involved and that the results are clear.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك لا يقل عن 18 عامًا؟
- Do you have multiple myeloma that has come back or isn't getting better with other treatments?
- Have you had at least three different types of myeloma treatments before?
- Are your other body organs, like your heart and kidneys, working well?
- Are you able and willing to follow the study's requirements, including not being pregnant or planning to be?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you'll be given Cemsidomide and Dexamethasone. You'll have regular visits to the hospital or clinic for check-ups, blood tests, and to make sure the treatment is working as expected and you're not experiencing any severe side effects. The exact schedule of these visits and tests will be explained to you in detail by the study team.
During your time in the study, doctors will closely monitor your health and how your multiple myeloma responds to the treatment. This will involve various medical assessments. The overall duration of your participation in the study will depend on how you respond to the treatment and what your doctor decides, but typically involves ongoing treatment cycles followed by a period of follow-up after the treatment has finished. You will be given clear instructions on your medication, including how and when to take it.
المخاطر والفوائد المحتملة
المواقع (60)
- Clearview Cancer Instituteالرمز البريدي المؤكدهانتسفيل، الولايات المتحدة· التوظيف
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- HonorHealthالرمز البريدي المؤكدسكوتسديل، الولايات المتحدة· التوظيف
- City of Hopeالرمز البريدي المؤكددوارتي، الولايات المتحدة· التوظيف
- Berenson Cancer Centerالرمز البريدي المؤكدويست هوليوود، الولايات المتحدة· التوظيف
- Mayo Clinic - Floridaالرمز البريدي المؤكدجاكسونفيل، الولايات المتحدة· التوظيف
- معهد وينشيب للسرطان، جامعة إيموريالرمز البريدي المؤكدأتلانتا، الولايات المتحدة· التوظيف
- Indiana University Healthالرمز البريدي المؤكدإنديانابوليس، الولايات المتحدة· التوظيف
- جامعة آيواالرمز البريدي المؤكدمدينة آيوا، الولايات المتحدة· التوظيف
- مركز بيث إسرائيل ديكونيس الطبيالرمز البريدي المؤكدبوسطن، الولايات المتحدة· لم يبدأ التوظيف بعد
- معهد دانا فاربر للسرطانالرمز البريدي المؤكدبوسطن، الولايات المتحدة· لم يبدأ التوظيف بعد
- مستشفى ماساتشوستس العامالرمز البريدي المؤكدبوسطن، الولايات المتحدة· التوظيف
أسئلة شائعة
ما هو الورم النقوي المتعدد؟
Multiple myeloma is a type of cancer that affects the plasma cells in your bone marrow, which are part of your immune system.
ماذا يعني 'الانتكاس/المقاوم'؟
It means the cancer has either come back after treatment, or it hasn't responded well to previous treatments.
What is Cemsidomide?
Cemsidomide is a new drug being tested in this study to see how well it works against multiple myeloma when combined with Dexamethasone.
Will I receive a placebo?
No, in this study, all participants will receive Cemsidomide along with Dexamethasone.
هل يمكنني التوقف عن المشاركة إذا أردت؟
Yes, you can choose to leave the study at any time, for any reason, without affecting your regular medical care.
كيفية معرفة المزيد
Study Medical Officer
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
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نقاش
مناقشة المجتمع
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