A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
This important study is investigating new treatments for multiple myeloma, a type of blood cancer. Specifically, it's for people who have been recently diagnosed and aren't suitable for a stem cell transplant. Researchers are comparing two different combinations of medicines: belantamab mafodotin, lenalidomide, and dexamethasone (called BRd) against daratumumab, lenalidomide, and dexamethasone (called DRd). The main goal is to see if one treatment combination can keep the cancer from getting worse for longer, or if it can help more people achieve a very low level of cancer cells in their body (known as 'minimal residual disease negative').
At a glance
What is this study about?
This study aims to find the best way to treat people who have recently been diagnosed with multiple myeloma and whose doctors don't recommend a stem cell transplant. Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. When these cells become cancerous, they can cause problems like bone damage and kidney issues.
Researchers are comparing two different treatment combinations. One group will receive a combination of medicines called BRd (belantamab mafodotin, lenalidomide, and dexamethasone). The other group will receive a different combination called DRd (daratumumab, lenalidomide, and dexamethasone). Both combinations include lenalidomide and dexamethasone, which are common treatments for multiple myeloma, but they differ in the third medicine included.
The main purpose of this study is to see if one of these combinations is better at keeping the cancer under control for longer (this is called 'progression-free survival'). They also want to see if one treatment helps more people achieve a state where there are very few or no detectable cancer cells left in their body, which is a good sign for long-term health. By comparing these treatments, doctors hope to find more effective options for people with newly diagnosed multiple myeloma who aren't able to have a stem cell transplant.
Key takeaways
- Compares two different drug combinations (BRd vs. DRd) for newly diagnosed multiple myeloma.
- For people who cannot have a stem cell transplant.
- Aims to see which treatment keeps the cancer under control for longer.
- Also checks if treatments can reduce cancer signs to very low levels.
- Participation involves regular check-ups and taking study medications.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been recently diagnosed with multiple myeloma. Your doctor must have determined that you need treatment for your multiple myeloma, and that you are not suitable for a high-dose chemotherapy followed by a stem cell transplant. This might be because of your age, or other health conditions you may have.
You would also need to have clear signs of multiple myeloma in your body that can be measured, for example, specific proteins in your blood or urine. Your general health and organ function would need to be good enough to take part in the study.
Because some of the medications can affect unborn babies, both men and women of child-bearing age would need to agree to use effective contraception during the study and for a period afterwards. Men would also need to agree not to donate semen.
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?
- Have you been newly diagnosed with multiple myeloma?
- Has your doctor said you cannot have a stem cell transplant?
- Do you have measurable signs of multiple myeloma?
- Are you able to use contraception if required?
What does participation involve?
If you join this study, you would receive one of the two treatment combinations (BRd or DRd). The specific schedule for taking these medicines would be explained to you by the study team. You would need to attend regular clinic visits for check-ups, blood tests, and other assessments to monitor your health and how well the treatment is working. This will likely involve multiple visits over several months or even years. The total duration of your participation, including regular follow-up, would depend on how your cancer responds to treatment and would be clearly outlined by the study team.
Potential risks and benefits
Locations (181)
- GSK Investigational SiteVerified postcodeMobile, United States· Recruiting
- GSK Investigational SiteVerified postcodePhoenix, United States· Recruiting
- GSK Investigational SiteVerified postcodeBeverly Hills, United States· Recruiting
- GSK Investigational SiteVerified postcodePasadena, United States· Recruiting
- GSK Investigational SiteVerified postcodeAurora, United States· Recruiting
- GSK Investigational SiteVerified postcodeWashington D.C., United States· Recruiting
- GSK Investigational SiteVerified postcodeEnglewood, United States· Recruiting
- GSK Investigational SiteVerified postcodeLady Lake, United States· Recruiting
- GSK Investigational SiteVerified postcodePembroke Pines, United States· Recruiting
- GSK Investigational SiteVerified postcodeSaint Augustine, United States· Recruiting
- GSK Investigational SiteVerified postcodeAtlanta, United States· Recruiting
- GSK Investigational SiteVerified postcodePortland, United States· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, a type of white blood cell found in the bone marrow. These cancerous cells can harm bones, kidneys, and the immune system.
What does 'ineligible for autologous stem cell transplantation' mean?
It means that a stem cell transplant, a common treatment for multiple myeloma, isn't suitable for you. This could be due to your age or other health conditions you might have.
What is the difference between BRd and DRd?
Both BRd and DRd are combinations of medicines for multiple myeloma. They both contain lenalidomide and dexamethasone, but BRd includes belantamab mafodotin, while DRd includes daratumumab. The study is comparing these two different third medicines.
What is 'progression free survival'?
Progression-free survival (PFS) is how long a person lives with cancer without the disease getting worse or spreading. The study wants to see if one treatment helps people stay in this state for longer.
Will I know which treatment I'm getting?
Often in these types of studies, participants don't know which specific treatment they are receiving until the study concludes. This is to ensure fair comparison of the treatments. The study team will provide more details.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
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