A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.
Doctors are conducting a Phase 3 study to test two different treatment combinations for multiple myeloma that has a specific genetic change called t(11;14). This type of multiple myeloma has either returned after treatment or didn't respond to earlier treatments. The study will compare venetoclax plus dexamethasone with pomalidomide plus dexamethasone. Both combinations already include dexamethasone, a type of steroid often used in cancer treatment. The main goal is to find out which combination keeps the disease from getting worse for longer. This research is important because it could help doctors understand the best way to treat people with this particular type of multiple myeloma.
At a glance
What is this study about?
This study is looking into new ways to treat multiple myeloma, a type of cancer that affects plasma cells in your bone marrow. Specifically, it's for people whose multiple myeloma has a particular genetic change, called t(11;14), and who have already had other treatments that either didn't work well or whose cancer has come back. The doctors want to find out if a new combination of medicines is better than a standard one.
The study will compare two different treatment plans. One group of patients will receive a drug called venetoclax along with dexamethasone. The other group will receive pomalidomide, also with dexamethasone. Dexamethasone is a common steroid used in cancer treatment. The main thing they want to measure is how long people live without their disease getting worse. This is known as "progression-free survival."
Understanding which treatment combination works best for this specific type of multiple myeloma is really important. The results could help more people with multiple myeloma live longer and have a better quality of life. By taking part, you could help doctors learn more and improve future treatments for others.
Key takeaways
- Tests two new drug combinations for multiple myeloma.
- Specifically for people with t(11;14)-positive multiple myeloma.
- For those whose cancer has returned or didn't respond to previous treatments.
- Aims to see which treatment keeps the disease from worsening for longer.
- Participation involves regular clinic visits and monitoring.
- You won't choose which treatment you receive.
Who may be eligible?
This study is looking for adults aged 18 and over who have been diagnosed with multiple myeloma. To be considered, your multiple myeloma must have a specific genetic feature called t(11;14), which will be checked with a special test. You also need to have tried at least two different types of treatments before, including lenalidomide and a proteasome inhibitor, and your cancer must have either gotten worse during or shortly after these treatments.
There are also some health requirements, such as having generally good liver and kidney function, and a good overall physical ability, as assessed by your doctor. You wouldn't be able to join if you've already had venetoclax, pomalidomide, or a similar drug, or if you have certain other health conditions like other active cancers from the last three years (with some exceptions) or if your multiple myeloma has spread to your brain or spinal cord.
Also, if you've had a stem cell transplant recently, there are specific timeframes you would need to meet before you could participate. The study team will review all your medical information carefully to see if this study is suitable 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.
- Are you 18 years old or older?
- Do you have multiple myeloma with the t(11;14) gene change?
- Has your multiple myeloma come back or not responded to at least two previous treatments (including lenalidomide and a proteasome inhibitor)?
- Are you generally able to do daily activities without much trouble?
- Have you *not* had venetoclax or pomalidomide before?
- Do you have good overall organ function (e.g., kidneys, liver)?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two treatment groups, meaning you won't choose which treatment you get. Both groups will receive a combination of medicines, including dexamethasone. You will have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medication. These visits will help the doctors monitor your health, how you are responding to the treatment, and any side effects you might experience.
The study will continue as long as the treatment is working for you and you are able to tolerate it. There will also be follow-up appointments even after you stop the study treatment to continue monitoring your health. The total duration of your participation, including follow-up, will depend on how your disease responds and other factors, and the study team will explain this in detail.
Potential risks and benefits
Locations (180)
- Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407Verified postcodeTucson, United States
- VA Central California Health Care System /ID# 200047Verified postcodeFresno, United States
- University of California, Los Angeles /ID# 171524Verified postcodeLos Angeles, United States
- Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904Verified postcodeAurora, United States
- Mayo Clinic /ID# 200075Verified postcodeJacksonville, United States
- Cleveland Clinic Florida /ID# 208884Verified postcodeWeston, United States
- Duplicate_Norton Cancer Institute /ID# 200834Verified postcodeLouisville, United States
- University of Maryland, Baltimore /ID# 217422Verified postcodeBaltimore, United States
- Boston Medical Center /ID# 223606Verified postcodeBoston, United States
- Barbara Ann Karmanos Cancer In /ID# 201377Verified postcodeDetroit, United States
- Duplicate_Henry Ford Hospital /ID# 171531Verified postcodeDetroit, United States
- Mayo Clinic - Rochester /ID# 201091Verified postcodeRochester, United States
Common questions
What is 't(11;14)-positive' multiple myeloma?
It's a specific genetic change found in some multiple myeloma cells. This study is for people who have this particular change.
What does 'relapsed or refractory' mean?
Relapsed means your cancer has returned after treatment. Refractory means your cancer didn't respond or stopped responding to previous treatments.
Will I get to choose which treatment I receive?
No, you will be randomly assigned to one of the two treatment groups, like flipping a coin, to ensure a fair comparison between the treatments.
What is a 'Phase 3' study?
This is a large study that compares a new treatment to an existing one, or to a placebo, to see if the new treatment is better or has fewer side effects. It's usually the final step before a treatment can be approved.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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