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RecruitingPHASE3INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE3
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrolment target
440
Start
12 Mar 2025
Estimated completion
22 Jun 2032

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.

  1. Are you an adult (18 years or older)?
  2. Have you been diagnosed with multiple myeloma that has come back or not responded to treatment?
  3. Have you previously been treated with lenalidomide?
  4. Do doctors currently see clear signs of your multiple myeloma that they can measure?
  5. Is your general health good enough to undertake a study treatment?
Answer every question to see your result.

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

Participating in this study might offer a potential benefit if the new treatment, BMS-986393, proves to be more effective than standard options for your multiple myeloma. However, as with any medical treatment, there are potential risks, including side effects from the study drugs. Some of these side effects might be serious. The study team will explain all known risks and closely monitor your health throughout. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (138)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Recruiting
  • UCLA Hematology/Oncology - Santa Monica
    Verified postcode
    Los Angeles, United States· Recruiting
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center
    Verified postcode
    Orange, United States· Recruiting
  • Local Institution - 0223
    Verified postcode
    Washington D.C., United States· Not yet recruiting
  • Baptist MD Anderson Cancer Center
    Verified postcode
    Jacksonville, United States· Recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
    Verified postcode
    Miami, United States· Recruiting
  • Local Institution - 0228
    Verified postcode
    Orlando, United States· Not yet recruiting
  • Winship Cancer Institute, Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • Louisiana State University Health Sciences Shreveport
    Verified postcode
    Shreveport, United States· Recruiting
  • Boston Medical Center
    Verified postcode
    Boston, United States· Recruiting
  • Local Institution - 0219
    Verified postcode
    Minneapolis, United States· Not yet recruiting
  • Weill Cornell Medical College
    Verified postcode
    New 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?

Register your interest

Share your details and the research team for "A Study to Compare the Efficacy and Safety of BMS-986393 Ver…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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