A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
This study is a first-time test in humans for a new drug called SAR446523. It's for adults in the UK who have a type of blood cancer called myeloma that has come back after treatment or is no longer responding to current medicines. The study wants to find the safest and most effective dose of SAR446523. It has two parts: first, finding the right dose, and then testing that dose in more people. Participants will take SAR446523 as an injection under the skin. The main goal is to see if this new treatment can help people whose myeloma has been difficult to treat.
At a glance
What is this study about?
This study is exploring a new medicine, SAR446523, for adults living with a specific type of blood cancer called multiple myeloma. This kind of myeloma has either returned after previous treatments or isn't responding to the usual medicines anymore. This is often called 'relapsed/refractory' myeloma, and it means new treatment options are really needed. The study is particularly interested in understanding if SAR446523 is safe to use and how well it might work against the cancer.
The study is split into two main sections. The first part is about carefully figuring out the best dose of SAR446523 to give. Researchers will start with very small doses and gradually increase them in different groups of people to find out what dose is both safe and has the best chance of being effective. This helps make sure that when more people take part, they receive a dose that's been well-researched.
Once a good dose range is identified, the second part of the study will involve more participants. These individuals will be randomly assigned to receive one of the chosen doses. This helps the researchers confirm the best dose and further understand how well the drug works for people with this challenging form of myeloma. The drug is given as an injection under the skin.
Key takeaways
- This study is for adults with multiple myeloma that has returned or is hard to treat.
- It's testing a new drug, SAR446523, given by injection under the skin.
- The study aims to find the safest and most effective dose of this new drug.
- Participation involves two phases: finding the dose, then testing it more widely.
- You can continue treatment as long as it's helping and side effects are manageable.
- You have the right to leave the study at any time.
Who may be eligible?
This study is looking for adults who have been diagnosed with multiple myeloma and whose cancer can be measured. For women and men, it's important to use birth control methods as advised by the study team.
To join the first part of the study (finding the right dose), you must have already tried at least three different treatments for your myeloma, and your cancer must have either come back or not responded to those treatments. It's okay if you've had certain other types of myeloma drugs before.
For the second part of the study (testing the best dose), you also need to have tried at least three different treatments, including specific types of drugs like certain anti-inflammatory medicines, proteasome inhibitors, and anti-CD38 antibodies, and your cancer must have come back or not responded to them. However, for this part, you can't have had a specific older type of drug called anti-GPRC5D therapy. There are also general health requirements, like having good organ function and not having other serious health conditions, or certain types of nerve damage or problems affecting the brain.
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 an adult with a confirmed diagnosis of multiple myeloma?
- Has your myeloma either come back after treatment or isn't responding to current medicines?
- Have you tried at least three different myeloma treatments previously?
- Are you generally feeling well enough to take part in such a study (your doctor will check this)?
- Are you able to use contraception if required by the study?
What does participation involve?
If you decide to take part in this study, the timing of your last visit can vary, as the study will continue until the last person has completed their final check-up. You'll keep receiving the study treatment, SAR446523 (given as an injection under the skin), for as long as it seems to be helping, and you're not experiencing difficult side effects. You, or your doctor, can decide to stop the treatment at any time if it's no longer suitable or if you wish to withdraw.
Potential risks and benefits
Locations (19)
- Mayo Clinic in Arizona - Phoenix- Site Number : 8400005Verified postcodePhoenix, United States· Recruiting
- Mayo Clinic in Florida- Site Number : 8400003Verified postcodeJacksonville, United States· Recruiting
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400004Verified postcodeRochester, United States· Recruiting
- Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001Verified postcodeHackensack, United States· Recruiting
- Thomas Jefferson University Hospital- Site Number : 8400002Verified postcodePhiladelphia, United States· Recruiting
- Investigational Site Number : 0360001Verified postcodeWollongong, Australia· Recruiting
- Investigational Site Number : 0360002Verified postcodeMelbourne, Australia· Recruiting
- Investigational Site Number : 1240005Verified postcodeVancouver, Canada· Recruiting
- Investigational Site Number : 1240001Verified postcodeMontreal, Canada· Recruiting
- Investigational Site Number : 1240002Verified postcodeSherbrooke, Canada· Recruiting
- Investigational Site Number : 2500002Verified postcodeLille, France· Recruiting
- Investigational Site Number : 2500001Verified postcodeNantes, France· Recruiting
Common questions
What is SAR446523?
SAR446523 is a new drug being tested for people with multiple myeloma that hasn't responded well to previous treatments.
How will I receive the drug?
The drug, SAR446523, will be given to you as an injection under your skin, like a small jab.
What is 'relapsed/refractory' myeloma?
This means your myeloma has either come back after you've had treatment or it's no longer responding to the medicines you're currently taking.
Can I stop participating in the study?
Yes, you can choose to stop participating in the study at any time, for any reason, and your regular medical care will not be affected.
What does 'first-in-human' mean?
It means this is the very first time this new drug is being given to people to see how safe and effective it is.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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