Daratumumab in combination with Carfilzomib, Pomalidomide and Dexamethasone (DCPD) in patients with multiple myeloma induced acute renal failure - "Time is Kidney in the Treatment of myeloma Cast nephropathy" The TIKTAC phase II trial (Pilot-study)
This study is called TIKTAC and focuses on people with multiple myeloma, a type of blood cancer, who also have kidney problems. Some people in the study are on dialysis because their kidneys have failed, while others have kidney damage but aren't yet on dialysis. The main goal is to see how well a combination of four medicines – daratumumab (DARZALEX), carfilzomib (Kyprolis), pomalidomide (Imnovid), and dexamethasone (Fortecortin) – helps improve kidney function. For those on dialysis, researchers want to know if they can stop needing it. For those not on dialysis, they're looking to see if their kidney health gets better. This is a Phase II study, meaning it's an early-stage trial looking at the treatment's effectiveness and safety.
At a glance
What is this study about?
This study is investigating a new way to treat multiple myeloma, a cancer that affects plasma cells in your bone marrow. Sometimes, this type of cancer can damage the kidneys, leading to serious problems. This particular study focuses on patients whose kidneys have been affected by their multiple myeloma. The study is called TIKTAC, which stands for "Time is Kidney in the Treatment of myeloma Cast nephropathy," highlighting how important it is to act quickly to protect the kidneys.
The researchers want to see if a combination of four existing medicines can help improve kidney function. These medicines are Darzalex (daratumumab), Kyprolis (carfilzomib), Imnovid (pomalidomide), and Fortecortin (dexamethasone). For patients who are currently receiving dialysis because their kidneys have stopped working, the study will check if this new treatment can help them recover enough to stop needing dialysis. For patients whose kidneys are damaged but who are not yet on dialysis, the study will look at how much their kidney health improves after receiving the treatment.
This is a Phase II study, which means it’s still in the early stages and aims to find out if the treatment works well and is safe. Patients will receive four cycles of this combination treatment. The team will carefully monitor how well their kidneys are working and also look at other important things like how the cancer responds to the treatment and any side effects people might experience.
Key takeaways
- This study is for people with multiple myeloma and kidney problems.
- It uses a combination of four medicines to try and improve kidney function.
- The study aims to help patients on dialysis reduce or stop needing it.
- It also checks if kidney function improves for those not yet on dialysis.
- This is an early-stage study (Phase II) looking at effectiveness and safety.
- Participation involves four cycles of treatment and regular medical checks.
Who may be eligible?
To join this study, you must be at least 18 years old. The study is open to both men and women.
The most important requirement is that you have multiple myeloma and that your kidneys have been damaged by the cancer. This includes people who are currently on dialysis because of their kidney problems and also those whose kidneys are not working as well as they should be, even if they aren't on dialysis yet.
There might be other health criteria that the doctors will review to make sure the study treatment is safe and appropriate for you. Your specialist doctor will be able to tell you if you meet all the requirements for this study.
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 a diagnosis of multiple myeloma?
- Has your multiple myeloma caused damage to your kidneys?
- Are you currently receiving dialysis for kidney problems?
- Or, do you have kidney problems due to myeloma but are not yet on dialysis?
What does participation involve?
If you join this study, you will receive a combination of four medicines (Daratumumab, Carfilzomib, Pomalidomide, and Dexamethasone) for four cycles. A 'cycle' is a period of treatment that usually involves receiving the medicines, followed by a break. During the study, you will have regular visits to the hospital or clinic to receive your treatment and have various tests and check-ups. These will include blood tests to monitor your kidney function, assess the cancer, and check for any side effects. You will also have assessments to see how you are generally feeling and coping with the treatment. The total duration of your active treatment participation will be for these four cycles, but there will be follow-up appointments afterwards to see how you are doing in the longer term.
Potential risks and benefits
Locations (1)
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Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that develops from plasma cells, a type of white blood cell, in your bone marrow.
What does 'kidney failure' mean?
Kidney failure means your kidneys can no longer properly filter waste from your blood, leading to a build-up of harmful substances in your body.
What is 'dialysis'?
Dialysis is a medical procedure that helps clean your blood when your kidneys are no longer able to do so, acting as an artificial kidney.
What do the different 'phases' of a clinical trial mean?
Clinical trials often have phases (I, II, III). Phase II means the study is looking at whether a treatment works and is safe in a larger group of people than in a Phase I study.
What kinds of checks will I have during the study?
You will have regular blood tests, physical examinations, and assessments to check your kidney function, how your cancer is responding, and to monitor for any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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