A Phase 3 Study Comparing Lenalidomide and Daratumumab Subcutaneous Injection (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy.
Multiple myeloma is a type of blood cancer that develops in the bone marrow. Standard intensive treatments, like high-dose chemotherapy and stem cell transplants, are often too harsh for people who are older, frail, or have other health conditions. This Phase 3 trial looks at a gentler approach for people who have not yet had treatment. Participants are placed into one of two groups by chance. One group receives the standard treatment: lenalidomide capsules taken with dexamethasone steroid tablets. The other group receives lenalidomide capsules along with daratumumab, an antibody drug given as a quick injection under the skin, avoiding regular steroid use. The main goal is to find out if the daratumumab combination keeps the cancer from growing for longer, improves quality of life, and causes fewer troublesome side effects than the standard steroid-based treatment.
At a glance
What is this study about?
Multiple myeloma affects plasma cells, a type of white blood cell found inside your bone marrow. While there are many effective treatments available today, some standard options involve high-dose chemotherapy that can be very hard on the body. For people who are frail, elderly, or managing other long-term illnesses, these intensive therapies are not safe or suitable.
Doctors usually treat frail patients with a combination of lenalidomide (a medicine that helps the immune system fight cancer cells) and dexamethasone (a strong steroid). While dexamethasone is effective, taking steroids for a long time can cause difficult side effects, including mood changes, sleep problems, weakened bones, and a higher risk of infections.
This trial investigates whether replacing the steroid with a targeted medicine called daratumumab gives better results. Daratumumab sticks directly to myeloma cells so the immune system can destroy them. Because it is given as a quick injection just under the skin, it may offer strong cancer control with fewer steroid-related complications. Researchers hope this study will lead to kinder, more effective treatment options for people who need a gentler approach.
Key takeaways
- The trial compares standard treatment against a newer targeted injection for multiple myeloma.
- It is specifically designed for people who are frail or cannot tolerate high-dose chemotherapy.
- Half of the participants receive daratumumab injections instead of regular steroid tablets.
- The study aims to see which option keeps the disease stable for longer with fewer side effects.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is designed specifically for adults who have been newly diagnosed with multiple myeloma and have not yet received any treatment for it.
To take part, doctors must have assessed you as 'frail' or unable to have intensive treatments such as high-dose chemotherapy or a stem cell transplant. This assessment considers your age, everyday fitness, and any other health conditions you may have.
Both men and women can join. However, you will not be able to participate if you have already started treatment for your myeloma, or if your doctor feels your general organ health makes taking part unsafe. Your hospital team will carry out detailed checks to confirm whether this trial is a good match for you.
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.
- I have been diagnosed with multiple myeloma.
- I have not yet started any treatment for my myeloma.
- My doctor has told me that an intensive stem cell transplant is not suitable for me.
- I am able and willing to attend regular hospital appointments for check-ups and treatments.
- I am happy to take part in a study where treatment is decided by random selection.
What does participation involve?
If you join the trial, a computer will assign you to one of two treatment groups by chance (like flipping a coin). You will have an equal chance of being in either group. One group takes lenalidomide capsules by mouth alongside dexamethasone steroid tablets. The other group takes lenalidomide capsules and receives daratumumab as an injection under the skin.
You will need to visit the hospital clinic regularly for your treatments and check-ups. At these visits, the team will give you your injections (if in that group), check your vital signs, ask how you are feeling, and take blood and urine samples. You may also need occasional bone marrow tests or scans to see how well the treatment is working.
You will stay on the study treatment for as long as it continues to help keep your cancer under control and you do not experience troublesome side effects. If your cancer changes or you decide to stop, your doctors will discuss other treatment options with you.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
Can I choose which treatment group I am in?
No. A computer assigns you to a group at random. This process ensures the trial results are fair, unbiased, and scientifically reliable.
How is the daratumumab injection given?
Daratumumab is given as a subcutaneous injection, which means a small needle delivers the medicine just under the skin, usually into the tummy area, taking only a few minutes.
Will I still receive standard care if I don't take part?
Yes. If you choose not to join, your haematology team will provide the best approved standard NHS treatment suitable for your condition.
What happens if my cancer worsens during the trial?
Your doctor will monitor your blood tests closely. If the treatment stops working, you will be taken off the study medicines and offered another suitable treatment.
Will I have to pay to take part?
No. The trial medicines and study-related tests are provided free of charge, and some trials offer support for travel expenses to hospital appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.