Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia
This study is for people with a rare, slow-growing blood cancer called Waldenström's macroglobulinaemia (WM). Current treatments for WM aren't always ideal, so researchers are looking for better options that are more effective and have fewer side effects. This trial, called RAINBOW, compares two treatments. One is a 'chemotherapy-free' approach using two drugs, rituximab and ibrutinib. The other is a standard treatment involving rituximab, cyclophosphamide, and dexamethasone. The aim is to see if the new combination can improve how well people respond, how long they stay well, and reduce unpleasant side effects, ultimately improving their lives. This study will involve 148 adults who haven't had treatment for WM before.
At a glance
What is this study about?
Waldenström's macroglobulinaemia (WM) is a type of blood cancer that grows slowly. It starts when certain white blood cells don't develop properly. This condition is more common in older people, typically those over 70. Unfortunately, the treatments currently available for WM don't always fully clear the cancer, and it often comes back. This means there's a real need to find new, more effective ways to treat it, giving people longer periods of good health and a better quality of life.
The RAINBOW study is designed to answer this need. It's comparing two treatment approaches. One is a newer 'chemotherapy-free' option that combines two drugs: rituximab and ibrutinib. Because there isn't one set 'best' first treatment for WM, we're comparing this new combination against a treatment that's widely considered a good standard option: rituximab, cyclophosphamide, and dexamethasone. By doing this, we hope to find a treatment that not only works better but also has fewer side effects, making it easier for people to manage their condition.
In this study, 148 adults, aged 18 and over, who haven't had treatment for WM before, will be randomly put into one of the two treatment groups. This randomisation means that neither you nor the doctors can choose which group you're in, which helps make the study results fair and reliable. The study will be carried out in NHS hospitals across the UK and is expected to run for about nine and a half years in total.
Key takeaways
- This study compares two treatments for Waldenström's macroglobulinaemia.
- It aims to find treatments that work better and have fewer side effects.
- People aged 18 and over who haven't been treated for WM before can join.
- Participants will be randomly assigned to one of two treatment groups.
- The study involves regular visits and long-term follow-up for about 9.5 years.
Who may be eligible?
To join this study, you must be 18 years or older and have a confirmed diagnosis of Waldenström's macroglobulinaemia that hasn't been treated yet. Your doctor will need to agree that treatment is necessary for your condition right now. This might be because your blood counts are low, you have certain symptoms like noticeable lumps or an enlarged spleen, or other signs that indicate you need treatment. You should also be generally well enough to take part, as assessed by your doctor, and expect to live longer than 6 months. Women who could become pregnant will need a negative pregnancy test and agree to use contraception during the trial.
You cannot join the study if you've already had treatment for your Waldenström's macroglobulinaemia. Also, if your cancer has spread to your brain or spinal cord, or if you have certain serious heart problems (like a recent heart attack, unstable chest pain, severe heart failure, or uncontrolled high blood pressure), you won't be able to participate. Recent major surgery or particular autoimmune conditions would also prevent you from joining.
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?
- Have you been diagnosed with Waldenström's macroglobulinaemia but haven't received treatment for it yet?
- Is your doctor recommending treatment for your WM now?
- Do you feel generally well enough to take part in a study?
- Do you have any serious heart conditions or a recent major surgery?
What does participation involve?
If you join the study, you'll be assigned to one of two treatment groups, like flipping a coin for fairness. The main treatment phase lasts for a maximum of 6 cycles. You'll have check-ups after 3 cycles and again around 24 weeks after starting treatment to see how well it's working. If you're in the group receiving Ibrutinib, you might continue taking just Ibrutinib for up to five years after the main treatment.
During and after treatment, you'll have regular hospital visits. These will be quite frequent during treatment, then every three months for five years after you finish treatment. After these five years, you'll have yearly check-ups to monitor your overall health until the study officially ends. Even if your condition changes, you'll still be followed up to track your survival. The total length of the study from start to finish is expected to be about nine and a half years.
Potential risks and benefits
Locations (25)
- Royal United Hospital, BathVerified postcodeBath, United Kingdom· Recruiting
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation TrustVerified postcodeBournemouth, United Kingdom· Recruiting
- East Kent Hospitals University NHS Foundation TrustVerified postcodeCanterbury, United Kingdom· Recruiting
- University Hospital of WalesVerified postcodeCardiff, United Kingdom· Recruiting
- Colchester HospitalVerified postcodeColchester, United Kingdom· Recruiting
- Mid Yorkshire NHS TrustVerified postcodeDewsbury, United Kingdom· Recruiting
- Royal Devon University HospitalVerified postcodeExeter, United Kingdom· Recruiting
- Medway Maritime HospitalVerified postcodeGillingham, United Kingdom· Recruiting
- Castle Hill HospitalVerified postcodeHull, United Kingdom· Recruiting
- NHS LanarkshireVerified postcodeLanark, United Kingdom· Recruiting
- St James's University HospitalVerified postcodeLeeds, United Kingdom· Recruiting
- Leicester Royal InfirmaryVerified postcodeLeicester, United Kingdom· Recruiting
Common questions
What is Waldenström's macroglobulinaemia?
It's a rare, slow-growing cancer that affects a type of white blood cell, usually seen in older adults.
What drugs are being tested?
One group gets rituximab and ibrutinib (a new combination). The other gets rituximab, cyclophosphamide, and dexamethasone (a widely used treatment).
Why is this study important?
Current treatments aren't perfect, so this study aims to find more effective options with fewer side effects to improve patients' lives.
How long will I be in the study if I join?
The main treatment lasts up to 6 cycles. You'll have regular check-ups for 5 years, then yearly follow-ups until the study ends (about 9.5 years total).
Do I have a choice of which treatment I get?
No, you'll be randomly assigned to one of the two treatment groups to ensure the study results are fair.
How to find out more
RAINBOW Trial Coordinator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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