What will happen if I join?
Your hospital doctor has planned for you to have treatment with Daratumumab, lenalidomide (also known as Revlimid®) and dexamethasone. This is known as DRd. This is an approved treatment for people newly diagnosed with myeloma who are not suitable for a stem cell transplant. DRd treatment is available to patients in the NHS.
You usually receive this treatment for as long as it is working, until your myeloma progresses (gets worse). If you take part in this research, you will receive DRd for around 6 months.
Each treatment cycle lasts 4 weeks (28 days), and you will receive:
- Daratumumab on days 1, 8, 15, and 22 of the first and second cycle, and days 1 and 15 of the third cycle onwards
- Lenalidomide on days 1 – 21
- Dexamethasone on days 1, 8, 15, and 22.
Before the start of each cycle of treatment, your hospital doctor will carry out some tests (including a blood test). This is to make sure it is safe and suitable for you to continue receiving treatment. As long as the tests show you are tolerating and responding to the treatment, you will receive a total of 6 cycles.
Daratumumab is given as an injection under the skin, so you may need to come into the hospital on these days. Your hospital doctor will let you know if this is the case. The first time you receive it, you will need to stay to be monitored for a few hours afterwards to check you haven’t had a reaction.
Lenalidomide is taken by mouth (orally) as capsules. You can take lenalidomide at home. It is important that you take it exactly as explained by your hospital doctor.
Dexamethasone is taken by mouth as either liquid, soluble or hard tablets. It is important that you take it exactly as explained by your hospital doctor. Dexamethasone may be given as an injection into the vein. Your hospital doctor will advise you if an injection is necessary.
You will also be given some additional medications to help combat the possible side effects of these myeloma treatments. Your hospital doctor will decide exactly which medications you need for this.
We expect this first 6 months of treatment to pose the same amount of risk as you would have from your usual care. This is because you will be receiving the usual NHS treatment DRd.
What else will happen during the 6 cycles of DRd treatment?
Blood and bone marrow samples
We will collect samples of your blood and bone marrow aspirate (fluid) at the following times:
- Before you start DRd (we will only collect bone marrow aspirate (fluid) if you did not previously share this with us), and
- After you have completed 6 cycles of DRd.
We will take up to an additional 4 teaspoons (20mL) of blood, and 2 teaspoons (10mL) of bone marrow aspirate (fluid) each time.
It is expected that most of the blood samples will be taken at the same time as your routine hospital tests. These should not require any additional needle punctures.
The bone marrow aspirate (fluid) sample after you complete 6 cycles of DRd is not usually performed as part of your usual care. However, the extra sample for this research allows us to personalise your further treatment. Parts of the sample will also be used in laboratory research to understand who responds best to which treatments.
Questionnaires
We will ask you to complete a set of questionnaires at the following times:
- Before you start DRd, and
- After you have completed 6 cycles of DRd.
This is to help us determine the impact of this research on your emotional and physical wellbeing, and how you have used healthcare services.
They can be completed when you attend clinic, or they will be posted to you if you cannot attend. The questionnaires are confidential. Your hospital doctor or nurse will not see what you have written.
Data collection
We will collect further data about you and your health:
- Before you start DRd,
- After 3 cycles of DRd, and
- After you have completed 6 cycles of DRd.
Your hospital doctor will look at some information about you, and if you have any other illnesses. They will also ask you some questions about your lifestyle. This is a way of determining your level of fitness.
We will ask you to complete functional activities, including a short walk test, a memory test and a drawing activity. We will do this to see whether we can find any patterns in how people respond.