A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
This research is investigating new treatment approaches for people with multiple myeloma, a type of blood cancer. The study focuses on combining a well-known drug, Daratumumab, with two newer medications, Talquetamab or Teclistamab. In some cases, another drug called Pomalidomide might also be included. The main aim is to carefully test these drug combinations to find the safest and most effective doses. Researchers will also be looking closely at how well these new combinations help control the cancer. This is a Phase 1 study, meaning it's an early stage of testing new treatments in people.
At a glance
What is this study about?
This study is for adults living with multiple myeloma, which is a cancer of certain white blood cells. When you have multiple myeloma, your body makes too many abnormal cells, which can cause problems like weak bones and a higher chance of infections. The treatments being explored in this study are combinations of existing and newer medications.
The idea behind this study is that by combining different drugs, we might be able to fight the cancer more effectively than with single drugs. Specifically, researchers are looking at Daratumumab, which is a medicine that targets specific markers on cancer cells. This is being combined with Talquetamab or Teclistamab, which are newer types of drugs designed to help your own immune system find and attack the cancer cells. In some cases, a medicine called Pomalidomide might also be added to these combinations.
Since this is an early-stage (Phase 1) study, the main goal is to figure out the safest dose of these drug combinations. Once a safe dose is found, the researchers will then look to see how well these combinations work at treating the multiple myeloma.
Key takeaways
- This study is for adults with multiple myeloma.
- It's testing new drug combinations, including Daratumumab with Talquetamab or Teclistamab, sometimes with Pomalidomide.
- The main goals are to find safe doses and see how well these combinations work.
- It's an early-stage (Phase 1) study.
- Participation involves regular visits and monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must have been diagnosed with multiple myeloma and have already tried at least three different types of treatment, including two specific kinds of drugs (called a proteasome inhibitor and an immunomodulatory drug). Alternatively, your cancer might be considered 'double refractory,' meaning it hasn't responded well to those two specific types of drugs.
Doctors will need to confirm that your multiple myeloma can be measured, either in your blood or urine. You also need to be generally well enough to take part, as assessed by a doctor. If you're a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study drugs.
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.
- Have I been diagnosed with multiple myeloma?
- Have I already tried at least three different types of myeloma treatments, including specific kinds of drugs?
- Can doctors measure my multiple myeloma in my blood or urine?
- Am I generally well enough to participate?
- If I am a woman, am I able to have a negative pregnancy test?
What does participation involve?
If you join this study, you'll go through several stages. First, there's a 'screening period' where doctors will check if you're suitable to take part. After that, you'll enter the 'treatment period.' This involves two main parts: first, a dose-finding stage to figure out the best amount of medication, and then a stage where more people receive the chosen dose. You'll receive the study drugs according to a schedule decided by the research team.
After your treatment finishes, there will be a 'post-treatment follow-up period' lasting up to 16 weeks to monitor your health. Some participants who are still benefiting from the treatment might be able to continue into a 'long-term extension period.' The study is expected to last about five and a half years in total. During this time, you'll have regular hospital visits for assessments, including blood tests and other checks, to monitor how you're responding to treatment and manage any side effects. The exact number of visits will be explained by the study team.
Potential risks and benefits
Locations (24)
- City of Hope National Medical CenterVerified postcodeDuarte, United States
- City of Hope Orange County Lennar Foundation Cancer CenterVerified postcodeIrvine, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- The Blavatnik Family Chelsea Medical Center at Mount SinaiVerified postcodeNew York, United States
- Mount Sinai Medical CenterVerified postcodeNew York, United States
- Levine Cancer InstituteVerified postcodeCharlotte, United States
- Wake Forest Baptist Medical CenterVerified postcodeWinston-Salem, United States
- University of PennsylvaniaVerified postcodePhiladelphia, United States
- Vanderbilt Ingram Cancer CenterVerified postcodeNashville, United States
- Medical College Of WisconsinVerified postcodeMilwaukee, United States
- Arthur J E Child Comprehensive Cancer CentreVerified postcodeCalgary, Canada
- University Health Network UHN Princess Margaret Cancer CentreVerified postcodeToronto, Canada
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 your bone marrow.
What does 'Phase 1' study mean?
Phase 1 is the first step of testing new drugs in people. The main goals are to find a safe dose and see if there are any serious side effects.
What are these drugs like?
Daratumumab helps your immune system find cancer cells. Talquetamab and Teclistamab are newer drugs that help direct your T-cells (another type of immune cell) to attack the cancer.
Will I get all the drugs mentioned?
The study tests combinations. You would receive Daratumumab plus either Talquetamab or Teclistamab. Pomalidomide might also be part of some combinations.
How long will I be involved?
Your direct treatment and follow-up could last several months, and the entire study is planned for about five and a half years. The study team will explain your specific timeline.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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