What happens after this?
If you are FIT or UNFIT, and MRD+ (you have current detectable myeloma cells in your bone marrow):
If you decide to continue to take part in this research, you would get one of the treatments by chance (randomly) based on how well you have responded to DRd, and your level of fitness after you have completed 6 cycles of DRd.
This means if you agree to continue to take part, you will have an equal chance of getting any of the treatments. You should only agree to continue to take part if you are happy with this.
We do this so that we can do a fair test of which treatment is best. We only do this because we do not know which of the treatments is best.
This process is called ‘randomisation’, and you will be randomised to one of the following treatments:
This could be a few months or several years.
This is continuing the NHS treatment that you would likely receive even if you were not taking part in this research.
You will continue your treatment as you have been. However, the daratumumab injection will be reduced to once a month (on day 1 of each 28-day cycle).
This is what you would receive outside of this research therefore the risk is the same.
Immunotherapy treatments help your own immune system fight myeloma.
You will receive:
-
Daratumumab
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 daratumumab injection will be reduced to once a month. -
Teclistamab
Teclistamab is given as an injection under the skin. It is started slowly, with two smaller doses (step-up doses) given before the first full dose. It will be given alongside daratumumab, which is also given as an injection under the skin. You may need to come into hospital on these days. You need to be monitored closely when starting teclistamab. This may mean being admitted to hospital for a period of time (usually about a week) or being monitored closely as an outpatient depending on your hospital’s usual practice.
After you stop the treatment, you will continue to be closely monitored by your hospital doctor for the duration of the research.
There are some different risks, compared with your usual care.
Immunotherapy treatments help your own immune system fight myeloma.
You will receive:
-
Daratumumab
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 daratumumab injection will be reduced to once a month. -
Talquetamab
Talquetamab is given as an injection under the skin. It is started slowly, with three smaller doses (step-up doses) given before the first full dose. It will be given alongside daratumumab, which is also given as an injection under the skin. You may need to come into hospital on these days. You need to be monitored closely when starting talquetamab. This may mean being admitted to hospital for a period of time (usually about 9 days) or being monitored closely as an outpatient depending on your hospital’s usual practice.
After you stop the treatment, you will continue to be closely monitored by your hospital doctor for the duration of the research.
There are some different risks, compared with your usual care.
People with myeloma often wish to know whether novel immunotherapy treatments are effective in treating myeloma. Immunotherapy treatments help your own immune system fight diseases.
You will help us answer this important question, even if you are not randomised (by chance) to receive one of the immunotherapy treatments (teclistamab or talquetamab).
If you are FRAIL, and MRD+ (you have current detectable myeloma cells in your bone marrow):
If you decide to continue to take part in this research, you would get one of the treatments by chance (randomly) based on how well you have responded to DRd, and your level of fitness after you have completed 6 cycles of DRd.
This means if you agree to continue to take part, you will have an equal chance of getting any of the treatments. You should only agree to continue to take part if you are happy with this.
We do this so that we can do a fair test of which treatment is best. We only do this because we do not know which of the treatments is best.
This process is called ‘randomisation’, and you will be randomised to one of the following treatments:
This could be a few months or several years.
This is continuing the NHS treatment that you would likely receive even if you were not taking part in this research.
You will continue your treatment as you have been. However, the daratumumab injection will be reduced to once a month (on day 1 of each 28-day cycle).
This is what you would receive outside of this research therefore the risk is the same.
This could be a few months or several years.
You will continue your treatment as you have been. However, the daratumumab injection will be reduced to once a month (on day 1 of each 28-day cycle), and you will no longer take dexamethasone.
There are some different risks, compared with your usual care.
People with myeloma who have previously received the NHS treatment DRd have often asked if dexamethasone can be stopped safely.
By continuing to take part, you will help us answer this important question, even if you are not randomised (by chance) to stop dexamethasone treatment.
If you are FIT, UNFIT, or FRAIL, and MRD- (you do not currently have detectable myeloma cells in your bone marrow):
If you decide to continue to take part in this research, you would get one of the treatments by chance (randomly) based on how well you have responded to DRd, regardless of your level of fitness.
This means if you agree to continue to take part, you will have an equal chance of getting any of the treatments. You should only agree to continue to take part if you are happy with this.
We do this so that we can do a fair test of which treatment is best. We only do this because we do not know which of the treatments is best.
This process is called ‘randomisation’, and you will be randomised to one of the following treatments:
This could be a few months or several years.
You will continue your treatment as you have been. However, the daratumumab injection will be reduced to once a month (on day 1 of each 28-day cycle), and you will no longer take dexamethasone.
There are some different risks, compared with your usual care.
You will continue your treatment as you have been. However, the daratumumab injection will be reduced to once a month (on day 1 of each 28-day cycle), and you will no longer take dexamethasone.
After 18 cycles you will stop the treatment and you will continue to be closely monitored by your hospital doctor around every 28 days.
There are some different risks, compared with your usual care.
People with myeloma often wish to know if they can have a treatment break after a fixed amount of time, without making the myeloma come back more quickly.
You will help us answer this important question, even if you are not randomised to stop treatment.
Before the start of each cycle of treatment, your hospital doctor will carry out some tests (including a blood test) to make sure it is safe and suitable for you to continue receiving treatment. This will also happen when you are not receiving treatment but are still being closely monitored by your hospital doctor, to see how you are doing.
You will continue to receive the treatment as planned, if the tests show you are tolerating the treatment, and your myeloma remains under control.
You will be given some additional medications to help combat the possible side effects of these myeloma treatments. Your hospital doctor will decide exactly which treatments you need for this.
Occasionally on receiving new information, your hospital doctor may consider it be in your best interests that you stop taking any further study treatment.
We will collect further bone marrow and blood samples, and we will ask you to complete more questionnaires.
There may be reasons why you can’t continue in the research and receive the further treatment. If you are not able to continue to take part in the research, your hospital doctor will discuss your alternative treatment options with you.
As with all research like this, the new treatment may not work as well as the best current treatments. But they might be as good as, or better, than current treatments. We are doing the research because we don’t know which is best.