A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
This study, called QUINTESSENTIAL-2, is looking at a new medicine for multiple myeloma, a type of blood cancer. We are comparing a new drug, BMS-986393, with existing common treatments. This is for adults whose multiple myeloma has either returned after initial treatment (relapsed) or has not responded well to previous treatments (refractory). Participants will have already received lenalidomide, a standard medication. The main aim is to check if BMS-986393 works better at controlling the cancer and to understand its potential side effects compared to the usual care. This research helps us find improved ways to treat multiple myeloma.
At a glance
What is this study about?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow. These cells are important for your immune system, but in multiple myeloma, they grow out of control. This study focuses on individuals whose multiple myeloma has either come back after past treatments (relapsed) or hasn't responded to previous medications (refractory). Specifically, it's for people who have already been treated with a medicine called lenalidomide.
The main goal of this study is to compare a new experimental drug, BMS-986393, with the treatments that are currently considered standard. Researchers want to find out if this new drug is more effective at treating the cancer and if it causes fewer or different side effects than current options. Finding new and better treatments is very important for patients living with multiple myeloma.
By taking part in studies like this, patients contribute to our understanding of multiple myeloma and help develop future treatments. This particular study is in 'Phase 3,' which means it involves a larger group of people and is one of the final steps before a new treatment might become widely available if it proves to be safe and effective.
Key takeaways
- This study is testing a new drug for multiple myeloma.
- It's for people whose cancer has returned or didn't respond to previous treatment, specifically after using lenalidomide.
- The study compares the new drug with current standard treatments.
- Its goal is to find out if the new treatment is safer and more effective.
- Participation involves regular hospital visits, tests, and medical monitoring.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You will need to have been diagnosed with multiple myeloma that has either returned or not responded to previous treatments, and you must have received treatment with lenalidomide before. Your doctors will also need to be able to measure your cancer, meaning there are clear signs of the disease that they can track.
Also, your body needs to be working well enough to handle the treatment, and you should be generally able to carry out your daily activities without too much difficulty. The research team will do some tests to make sure you meet all these health requirements.
You cannot join if your multiple myeloma has spread to your brain or spinal cord, or if your cancer is so aggressive that you need immediate treatment. Also, if you only have a single growth of cancer cells (a solitary plasmacytoma) or non-secretory myeloma without other measurable signs of disease, you might not be able to take part.
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 (18 years or older)?
- Have you been diagnosed with multiple myeloma that has come back or not responded to treatment?
- Have you previously been treated with lenalidomide?
- Do doctors currently see clear signs of your multiple myeloma that they can measure?
- Is your general health good enough to undertake a study treatment?
What does participation involve?
If you decide to join this study, you will receive either the new drug, BMS-986393, or a standard treatment for multiple myeloma. The specific schedule for your medication and any doctor's visits, tests, and scans will be clearly explained by the study team. You will have regular appointments where doctors will check how you are responding to treatment and monitor for any side effects.
These visits will involve blood tests, physical exams, and other medical assessments to track your health and the progress of your multiple myeloma. The total length of your participation will vary, but it includes the treatment period and then a follow-up period where doctors will continue to monitor your health, even after you stop taking the study medication.
Potential risks and benefits
Locations (138)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- UCLA Hematology/Oncology - Santa MonicaVerified postcodeLos Angeles, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical CenterVerified postcodeOrange, United States· Recruiting
- Local Institution - 0223Verified postcodeWashington D.C., United States· Not yet recruiting
- Baptist MD Anderson Cancer CenterVerified postcodeJacksonville, United States· Recruiting
- University of Miami Hospital and Clinics, Sylvester Cancer CenterVerified postcodeMiami, United States· Recruiting
- Local Institution - 0228Verified postcodeOrlando, United States· Not yet recruiting
- Winship Cancer Institute, Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- Louisiana State University Health Sciences ShreveportVerified postcodeShreveport, United States· Recruiting
- Boston Medical CenterVerified postcodeBoston, United States· Recruiting
- Local Institution - 0219Verified postcodeMinneapolis, United States· Not yet recruiting
- Weill Cornell Medical CollegeVerified postcodeNew York, United States· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are white blood cells found in your bone marrow.
What does 'relapsed or refractory' mean?
It means the cancer has come back after previous treatment (relapsed) or hasn't responded well to earlier treatments (refractory).
What is BMS-986393?
BMS-986393 is the name of the new experimental drug being tested in this study for multiple myeloma.
Will I definitely get the new drug?
No, participants will either receive the new drug or a standard treatment. Which one you get is decided by chance, like flipping a coin.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and your medical care will not be affected.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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